Clinical Research & Trials

Blood Cancer: Dose-Escalation Study of VLS-101

Lead Researcher: Paul Barr

This is a Phase 1 dose-escalation study evaluating the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and efficacy of the novel drug, VLS-101, across a range of dose levels when administered to subjects with previously treated relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma, mantle cell lymphoma, follicular lymphoma, marginal zone lymphoma, diffuse large B-cell lymphoma, or Richter transformation lymphoma.

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Pembrolizumab with Lenvatinib vs. Docetaxel in Participants with Lung Cancer Growth After Chemotherapy and Immunotherapy

Lead Researcher: Ronald Maggiore

This study will evaluate the efficacy and safety of pembrolizumab (MK-3475) with lenvatinib (E7080/MK-7902) vs. docetaxel in participants with metastatic non-small cell lung cancer (NSCLC) and progressive disease (PD) after platinum doublet chemotherapy and treatment with an anti-PD-1/PD-L1 monoclonal antibody (mAb). The primary hypotheses of this study are that pembrolizumab + lenvatinib (compared with docetaxel) prolongs: 1) overall survival (OS); and progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) based on blinded independent central review (BICR).

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Study of Abaloparatide and Bevacizumab in Myelodysplastic Syndromes

Lead Researcher: Jason Mendler

The primary objective of this study is to determine the safety and tolerability of combined abaloparatide and bevacizumab in patients with Myelodysplastic Syndromes (MDS). A secondary objective is to determine the response to treatment (based on bone marrow and peripheral blood findings). A tertiary objective is to determine the impact of therapy on health-related quality of life (HRQOL) and patient-reported outcomes (PRO). A quaternary (scientific) objective is to determine the impact of treatment on both hematopoietic and stromal cell populations within the bone marrow of MDS patients.

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Study of infusion treatment, axicabtagene ciloleucel, for patients with Indolent Non-Hodgkin Lymphoma

Lead Researcher: Carla Casulo

Axicabtagene ciloleucel is an experimental product made from the subject's own white blood cells which are genetically modified and grown to fight cancer. Patients will be infused with axicabtagene ciloleucel to see if their disease responds and if this product is safe. This study will enroll approximately 160 adult subjects who have relapsed or refractory Indolent Non-Hodgkin Lymphoma.

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A Disease Registry of Patients With Mantle Cell Lymphoma

Lead Researcher: Paul Barr

The purpose of this study is to create a patient registry in order to assess treatment patterns, physician-reported clinical outcomes and patient-reported health-related quality of life among patients diagnosed with Mantle Cell Lymphoma (MCL). Eligible patients will have newly initiated a novel therapy in the past 3 months with treatment ongoing at the time of enrollment.

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A Drug Study of Ibrutinib + Obinutuzumab in Patients with Chronic Lymphocytic Leukemia (CLL)

Lead Researcher: Paul Barr

This research study is evaluating a combination of two drugs, ibrutinib and obinutuzumab, as a possible treatment for Chronic Lymphocytic Leukemia (CLL).

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A Multi-Center Study of SM-88 in Subjects With Pancreatic Cancer

Lead Researcher: Marcus Noel

A prospective, open-label phase 2 trial in metastatic pancreatic cancer subjects who have failed at least one line of any prior chemotherapy. The trial is designed to evaluate the of SM-88 therapy on pancreatic cancer and will measure multiple efficacy and safety endpoints, including overall response rate, overall survival, progression free survival, relevant biomarkers, quality of life and safety. In the initial stage of the trial (36 subjects), two dose levels of SM-88's metyrosine-derivative will be evaluated.

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A Phase 2 Study of Ruxolitinib With Chemotherapy in Children With Acute Lymphoblastic Leukemia

Lead Researcher: Angela Girvin

This is a nonrandomized study of ruxolitinib in combination with a standard multi-agent chemotherapy regimen for the treatment of B-cell acute lymphoblastic leukemia. Part 1 of the study will optimize the dose of study drug (ruxolitinib) in combination with the chemotherapy regimen. Part 2 will evaluate the efficacy of combination chemotherapy and ruxolitinib at the recommended dose determined in Part 1.

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A Study Comparing the Efficacy and Safety of Polatuzumab Vedotin With Rituximab-Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Rituximab-Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Diffuse Large B-Cell Lymphoma

This Phase III, randomized, double-blind, placebo-controlled study will compare the efficacy, safety, and pharmacokinetics of polatuzumab vedotin plus R-CHP versus R-CHOP in participants with previously untreated diffuse large B-cell lymphoma (DLBCL).

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A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia

Glasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population). Glasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).

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A Study of Baricitinib (LY3009104) in Participants With Severe or Very Severe Alopecia Areata

Lead Researcher: Mary Gail Mercurio

This study is designed to select up to two doses of baricitinib (referred to as low dose and high dose) and assess their efficacy and safety for the treatment of severe or very severe alopecia areata.

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A Study of Bemarituzumab (FPA144) Combined With Modified FOLFOX6 (mFOLFOX6) in Gastric/Gastroesophageal Junction Cancer (FIGHT)

This is a global, randomized, double-blind, controlled study to evaluate the efficacy of bemarituzumab (FPA144) + mFOLFOX6 versus placebo + mFOLFOX6 in patients with FGFR2 selected Gastric Cancer (as determined by prospective IHC FGFR2b overexpression and/or a ctDNA blood assay demonstrating FGFR2 gene amplification)

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A Study of BMS-813160 in Combination With Chemotherapy or Nivolumab in Patients With Advanced Solid Tumors

Lead Researcher: Marcus Noel

This study will evaluate the safety profile, tolerability, and effectiveness of the drug BMS-813160 in patients with metastatic colorectal and pancreatic cancers.

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A Study of DSP-7888 Dosing Emulsion in Adult Patients With Advanced Malignancies

Lead Researcher: Nimish Mohile

This is a dose-escalation study of DSP-7888 Dosing Emulsion administered to adult patients with advanced malignancies. Patients will be administered escalating doses of DSP-7888 Dosing Emulsion intradermally (between the skin layers) or subcutaneously (under the skin) in accordance with the following regimen: once weekly for four weeks during the Induction Phase, once every 7 to 14 days for 6 weeks during the Consolidation Phase, and once every 14 to 28 days until a discontinuation criterion is met during the Maintenance Phase. Once the highest dose with acceptable toxicity is determined from either the intradermal or subcutaneous group, an additional 40 patients may be enrolled as an expansion cohort at this dose and route of administration to confirm safety and tolerability. Separate from the dose-ascending cohort and expansion cohort described previously, and once the intradermal dose-ascending cohort is completed, up to 20 myelodysplastic syndrome (MDS) patients who are resistant to treatment with hypomethylating agents (HMAs) will be enrolled into an MDS expansion cohort. Of these 20 MDS patients, one-half will receive DSP-7888 at 10.5 mg according to the modified schedule employed in Phase 1 (every week for 4 weeks, every 2 weeks until Week 24, and then every 4 weeks [Named MDS Cohort 1]). The other half of the MDS patients will receive DSP-7888 at 10.5 mg in an alternative dosing schedule where DSP-7888 is administered every 2 weeks until Week 24, after which it will be administered every 4 weeks (Named MDS Cohort 2).

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A Study of DSP-7888 Dosing Emulsion in Combination With Bevacizumab in Patients With Recurrent or Progressive Glioblastoma Following Initial Therapy

This is a randomized, active-controlled, multicenter, open-label, parallel groups, Phase 2 study of DSP-7888 Dosing Emulsion plus Bevacizumab versus Bevacizumab alone in patients with recurrent or progressive glioblastoma multiforme (GBM) following treatment with first line therapy consisting of surgery and radiation with or without chemotherapy.

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A Study of Elotuzumab With Pomalidomide, Bortezomib, and Dexamethasone in Relapsed Multiple Myeloma

Lead Researcher: Brea Lipe

This research study is studying a combination of study drugs as a possible treatment for relapsed and refractory Multiple Myeloma. The interventions involved in this study are elotuzumab, pomalidomide, bortezomib, dexamethasone.

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A Study of IMO-2125 in Combination With Ipilimumab in Subjects With Melanoma (ILLUMINATE-301)

Lead Researcher: Deepak Sahasrabudhe

A Phase 3 global, multi-center, open-label comparison of ipilimumab with and without intratumoral IMO-2125 in subjects with advanced melanoma who had confirmed disease progression while on nivolumab or pembrolizumab

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A Study of INCMGA00012 in Metastatic Merkel Cell Carcinoma

Lead Researcher: Adrienne Victor

The purpose of this study is to assess the clinical activity and safety of INCMGA00012, a monoclonal antibody, in participants with metastatic merkel cell carcinoma (MCC).

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A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease

Lead Researcher: Lawrence Saubermann

The purpose of this program is to evaluate the efficacy and safety of guselkumab in participants with Crohn's disease.

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A Study of the Safety and Effectiveness of Apixaban in Preventing Blood Clots in Children With Leukemia Who Have a Central Venous Catheter and Are Treated With Asparaginase

Lead Researcher: Angela Girvin

The purpose of this study is to compare the effect of a blood thinning drug called Apixaban versus no administration of a blood thinning drug, in preventing blood clots in children with leukemia or lymphoma. Patients must be receiving chemotherapy, including asparaginase, and have a central line (a catheter inserted for administration of medications and blood sampling)

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A Study to Compare the Efficacy and Safety of Ustekinumab to that of Adalimumab in the Treatment of Subjects with Active Crohn’s Disease

Lead Researcher: Lawrence Saubermann

The purpose of this study is to compare the effectiveness of the drug Ustekinumab to the drug Adalimumab in patients who have moderate to severe Crohn's disease. The study will test Ustekinumab compared to Adalimumab for 56 weeks. To determine if the effectiveness of each drug, patients will come to the clinic regularly to meet with the study team, complete questionnaires, and have blood work completed.

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A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) Amyloidosis

The purpose of this study is to evaluate the efficacy and safety of daratumumab plus cyclophosphamide, bortezomib and dexamethasone (CyBorD) compared with CyBorD alone in treatment of newly diagnosed amyloid light chain (AL) amyloidosis participants.

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A Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Participants With Diabetic Macular Edema

Lead Researcher: Ajay Kuriyan

This study will evaluate the efficacy, safety, and pharmacokinetics of faricimab administered at 8-week intervals or as specified in the protocol following treatment initiation, compared with aflibercept once every 8 weeks (Q8W), in participants with diabetic macular edema (DME).

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A Study to Evaluate the Efficacy and Safety of RO7105705 in Patients With Prodromal to Mild Alzheimer's Disease

This is a phase II, randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of RO7105705 in participants with prodromal to mild Alzheimer's disease. An optional 96-week open-label extension period will be available to participants who complete the double-blind treatment period and who, in the judgment of the investigator, would potentially benefit from open-label RO7105705 treatment.

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A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared With Placebo and With Vedolizumab in Participants With Moderate to Severe Ulcerative Colitis (UC)

Lead Researcher: Lawrence Saubermann

This study is designed to evaluate the efficacy, safety, and pharmacokinetics of UTTR1147A compared with vedolizumab and with placebo in the treatment of participants with moderate to severe UC. This study will consist of two parts, Part A and Part B. Part A will test the induction of clinical remission and Part B will test the durability of clinical remission.

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A Study to Investigate the Effects of GC4419 on Radiation Induced Oral Mucositis in Patients With Head/Neck Cancer

Lead Researcher: Ronald Maggiore

The purpose of the phase 3, clinical study is to determine if GC4419 administered prior to intensity-modulated radiation therapy (IMRT) reduces the severity of radiation induced oral mucositis in patients who have been diagnosed with locally advanced, non-metastatic squamous cell carcinoma of the head and neck.

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A Study to Test Radium-223 Therapy With Docetaxel Chemotherapy in Patients With Prostate Cancer

Lead Researcher: Chunkit Fung

The purpose of this study is to compare any good and bad effects of using radium-223 therapy along with docetaxel chemotherapy treatment versus using docetaxel alone.

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Active Surveillance, Bleomycin, Carboplatin, Etoposide, or Cisplatin in Treating Pediatric and Adult Patients With Germ Cell Tumors

Lead Researcher: Angela Girvin

This partially randomized phase III trial studies how well active surveillance, bleomycin, carboplatin, etoposide, or cisplatin work in treating pediatric and adult patients with germ cell tumors. Active surveillance may help doctors to monitor subjects with low risk germ cell tumors after their tumor is removed. Drugs used in chemotherapy, such as bleomycin, carboplatin, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

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Acute Myeloid Leukemia (AML): Crenolanib Versus Midostaurin in Newly Diagnosed Subjects With FLT3 Mutated AML

Lead Researcher: Jane Liesveld

This purpose of this study is to compare the efficacy of crenolanib with midostaurin administered following induction chemotherapy and consolidation therapy on event-free survival in newly diagnosed acute myeloid leukemia subjects with FLT3 mutation.

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Acute Myeloid Leukemia (AML): Intensive Chemotherapy with or without Glasdegib or AZA with or without Glasdegib

Lead Researcher: Jane Liesveld

The purpose of this study is to determine if glasdegib is superior to placebo in combination with azacitidine or cytarabine and daunorubicin in prolonging overall survival in subjects with untreated AML.

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Acute Myeloid Leukemia (AML): Study of Crenolanib vs Midostaurin Following Induction Chemotherapy and Consolidation Therapy in Newly Diagnosed FLT3 Mutated AML

Lead Researcher: Jane Liesveld

A phase III randomized multi-center study designed to compare the efficacy of crenolanib with that of midostaurin when administered following induction chemotherapy, consolidation chemotherapy and bone marrow transplantation in newly diagnosed AML subjects with FLT3 mutation. About 510 subjects will be randomized in a 1:1 ratio to receive either crenolanib in addition to standard first line treatment of AML (chemotherapy and if eligible, transplantation) (arm A) or midostaurin and standard treatment (arm B). Potentially eligible subjects will be registered and tested for the presence of FLT3 mutation. Once the FLT3 mutation status is confirmed and additional eligibility is established, subject will be randomized and enter into the treatment phase.

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Acute Myeloid Leukemia (AML): Uproleselan Administered With Chemotherapy Versus Chemotherapy Alone in Patients With Relapsed/Refractory AML

Lead Researcher: Jane Liesveld

The purpose of this trial is to compare overall survival achieved with uproleselan administered with chemotherapy versus chemotherapy alone.

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ADMET2

Lead Researcher: Anton Porsteinsson

Apathy in Dementia Methylphenidate Trial 2 (ADMET 2) is a Phase III, placebo-controlled, masked, 6 month, 10-center randomized clinical trial sponsored by National Institute of Aging involving 200 participants with Alzheimer's disease (AD). ADMET 2 is designed to examine the efficacy and safety of methylphenidate as treatment for clinically significant apathy in AD. participants. ADMET 2 will enroll participants from real world settings such as outpatient, nursing home, and assisted living facilities and will examine the effects of methylphenidate on apathy and cognition. ADMET 2 will also conduct careful safety monitoring.

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ADNI3

Lead Researcher: Anton Porsteinsson

ADNI3 is not a treatment study. It continues research that began in 2004 (ADNI1) and will follow people over a five year period using the information collected from thinking and memory testing, brain imaging, genetics testing, and blood and brain-spinal fluid testing to help improve the way AD research is conducted. Approximately 1070 - 2000 participants will be enrolled at 59 sites in the US and Canada. Three groups will be enrolled and evaluated: those with normal thinking and memory, those with mild cognition problems, and those with mild Alzheimer's disease. The normal thinking cohort is filled; the study is now only recruiting people with mild cognition problems (MCI) or mild Alzheimer's disease.

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Amyloidosis: A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) Amyloidosis

Lead Researcher: Frank Passero

There are two treatment groups in this study. The study medication will be given in treatment cycles, and each cycle is 28 days long. Group A: Cyclophosphamide, bortezomib (VELCADE®) and dexamethasone (CyBorD). Group B: Daratumumab plus cyclophosphamide, bortezomib (VELCADE®) and dexamethasone (CyBorD)

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Amyloidosis: S1702 Isatuximab in Treating Patients With Relapsed or Refractory Primary Amyloidosis

Lead Researcher: Frank Passero

All participants will receive the same study drug. If you decide to participate, you will receive up to 24 cycles (1 cycles = 28 days) of the study drug, isatuximab, as an outpatient (meaning you will not be admitted to the hospital to receive study drug. During the first cycle (or 28 days), you will receive isatuximab on Day 1, 8, 15 and 22 by intravenous (IV) infusion (into your vein). For all other cycles (Cycle 2, up to Cycle 24), you will receive isatuximab on Days 1 and 15.

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Antiandrogen Therapy and Radiation Therapy With or Without Docetaxel in Treating Patients With Prostate Cancer That Has Been Removed by Surgery

Lead Researcher: Yuhchyau Chen

This randomized phase II/III trial studies docetaxel, antiandrogen therapy, and radiation therapy to see how well it works compared with antiandrogen therapy and radiation therapy alone in treating patients with prostate cancer that has been removed by surgery. Androgen can cause the growth of prostate cells. Antihormone therapy may lessen the amount of androgen made by the body. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving antiandrogen therapy and radiation therapy with or without docetaxel after surgery may kill any remaining tumor cells.

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Apixaban for the Acute Treatment of Venous Thromboembolism in Children

To assess the safety and descriptive efficacy of apixaban in pediatric subjects requiring anticoagulation for the treatment of a VTE.

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Aspirin in Preventing Recurrence of Breast Cancer

Lead Researcher: Kristin Skinner

This randomized phase III trial studies how well aspirin works in preventing the cancer from coming back (recurrence) in patients with human epidermal growth factor receptor 2 (HER2) breast cancer after chemotherapy, surgery, and/or radiation therapy. Aspirin is a drug that reduces pain, fever, inflammation, and blood clotting. It is also being studied in cancer prevention. Giving aspirin may reduce the rate of cancer recurrence in patients with breast cancer.

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Biliary Cancer: Phase 1b PEGPH20 with Cis & Gem; PEGPH20 with Atezolizumab, Cis & Gem; and compared with Cis & Gem alone in HA-High Subjects with Metastatic Intrahepatic and Extrahepatic Cholangiocarcinoma and Gallbladder Adenocarcinoma

Lead Researcher: Marcus Noel

If you participate in the Run In portion of this study, you will be assigned to one of two treatment groups. You can be assigned to receive either PEGPH20 plus Cisplatin and Gemcitabine or PEGPH20 plus Cisplatin and Gemcitabine and Atezolizumab. If you participate in the Dose Expansion portion of the study, you will be assigned to one of three different treatment groups. You can be assigned to receive PEGPH20 plus Cisplatin and Gemcitabine, PEGPH20 plus Cistplatin and Gemcitabine and Atezolizumab or Cisplatin and Gemcitabine alone.

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Biomarkers in Tumor Tissue Samples From Patients With Newly Diagnosed Neuroblastoma or Ganglioneuroblastoma

Lead Researcher: Angela Girvin

This research trial studies biomarkers in tumor tissue samples from patients with newly diagnosed neuroblastoma or ganglioneuroblastoma. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.

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Bladder Cancer: A Study to Evaluate the Efficacy and Safety of INCB054828 in Subjects With Urothelial Carcinoma

Lead Researcher: Chunkit Fung

The primary purpose of this research study is to assess how metastatic or surgically unresectable Urothelial Carcinoma with FGF/FGFR alterations responds to treatment with INCB054828. The other goals of the study are to determine how safe and well tolerated the study drug, INCB054828, is, and to obtain data to try and identify patients who would benefit most from INCB054828.

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Bladder Cancer: Atezolizumab in BCG-Unresponsive Non-Muscle Invasive Bladder Cancer S1605

Lead Researcher: Deepak Sahasrabudhe

The purpose of this study is to estimate complete response at 25 weeks after registration.

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Bladder Cancer: Different Strains of BCG With or Without Vaccine in High Grade Non- Muscle Invasive Bladder Cancer

Lead Researcher: Edward Messing

This study has 3 study groups; Group 1 will receive the usual BCG LIVE (TICE® BCG) version of BCG in the bladder, Group 2 will receive BCG in the bladder but it will be the Tokyo-172 version of BCG instead of the BCG LIVE (TICE® BCG) version, and Group 3 will receive a vaccination as an injection under the skin with the Tokyo-172 version of BCG followed by receiving the Tokyo-172 version in the bladder. A computer will assign you to treatment groups in the study by chance. This is done by chance because no one knows if one study group is better or worse than the others. Neither you nor your doctor will be able to choose your treatment.

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Bladder Cancer: Study of Pembrolizumab With or Without Platinum-based Combination Chemotherapy Versus Chemotherapy Alone in Urothelial Carcinoma

Lead Researcher: Elizabeth Guancial

If you agree to and are allowed to participate in this study, you will be assigned by 33% chance (a process called randomization similar to rolling a dice) to one of three treatment groups: • Subjects assigned to Treatment Group A, will receive pembrolizumab • Subjects assigned to Treatment Group B, will receive the combination of pembrolizumab and chemotherapy (either cisplatin or carboplatin with gemcitabine). • Subjects assigned to Treatment Group C, will receive chemotherapy (either cisplatin or carboplatin with gemcitabine). Both you and your doctor will know which treatment group you have been assigned to.

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Bladder Cancer: study on a drug delivery system (TAR-200)

Lead Researcher: Chunkit Fung

TAR-200 is a drug-device product that continuously releases a chemotherapy drug (called gemcitabine) in the bladder over several days. The purpose of this study is to determine if TAR-200, when combined with a first-line treatment (a drug called nivolumab) is safe and tolerable in patients with muscle-invasive bladder cancer (MIBC).

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Blinatumomab in Treating Younger Patients With Relapsed B-cell Acute Lymphoblastic Leukemia

Lead Researcher: Angela Girvin

This randomized phase III trial studies how well blinatumomab works compared with standard combination chemotherapy in treating patients with B-cell acute lymphoblastic leukemia that has returned after a period of improvement (relapsed). Monoclonal antibodies, such as blinatumomab, may interfere with the ability of tumor cells to grow and spread. It is not yet known whether standard combination chemotherapy is more effective than blinatumomab in treating relapsed B-cell acute lymphoblastic leukemia.

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Blood Cancer: A Study of APTO-253 in Patients With Acute Myelogenous Leukemia (AML) or Myelodysplastic Syndrom (MDS)

Lead Researcher: Kristen O'Dwyer

This study is being done to evaluate the safety and effectiveness of APTO-253 for the treatment of patients with the condition of acute myelogenous leukemia (AML) or myelodysplastic syndrome (MDS) for which either the standard treatment has failed, is no longer effective, or can no longer be administered safely or poses a risk for your general well being.

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Blood Cancer: Denosumab for Smoldering Multiple Myeloma

Lead Researcher: Brea Lipe

This is a trial of denosumab 120mg subcutaneous (under the skin) for patients with smoldering multiple myeloma (SMM). SMM is a plasma cell disorder has a high risk of progressing to multiple myeloma (MM). Participants will be recruited from the James P. Wilmot Cancer Center, University of Rochester in Rochester, New York. Patients seen in the inpatient or outpatient setting with histologically confirmed SMM will be evaluated for this study. 20 patients will be treated with a dose of denosumab every 4 weeks over the course of a year. Patients will be followed after completion of the study for an additional 2 years. All patients will take daily vitamin D and calcium supplements.

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Brain Training to Promote Health in Family Dementia Caregivers

Lead Researcher: Kathi Heffner

The purpose of the study is to determine whether two types of in-home “brain-training” programs may have beneficial health effects, including reduced stress and improved immune health, for individuals caring for a loved one (spouse, parent, friend, etc) who has dementia. Participation involves completing one of our brain training programs with the use of a computer at home a few times a week (when convenient for you), over eight weeks. Experience or skill with computers is not necessary. If you do not own a computer, one may be provided for you to use during the program period.

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Breast Cancer Weight Loss Study (BWEL Study)

Lead Researcher: Kristin Skinner

This randomized phase III trial studies whether weight loss in overweight and obese women may prevent breast cancer from coming back (recurrence). Previous studies have found that women who are overweight or obese when their breast cancer is found (diagnosed) have a greater risk of their breast cancer recurring, as compared to women who were thinner when their cancer was diagnosed. This study aims to test whether overweight or obese women who take part in a weight loss program after being diagnosed with breast cancer have a lower rate of cancer recurrence as compared to women who do not take part in the weight loss program. This study will help to show whether weight loss programs should be a part of breast cancer treatment.

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Breast Cancer: Evaluation of ParsortixTM PC1 System using Blood Sample from Metastatic Breast Cancer Patients and Healthy Volunteers

Lead Researcher: Richard Moore

The purpose of this study is to evaluate the performance of the ParsortixTM PC1 system, a semi-automated system capable of capturing and harvesting rare cells for subsequent analysis from bodily fluids based on the size and deformability (i.e. compressibility) of the cells, in the capture and harvesting of cells using whole blood samples collected from healthy women and women with metastatic breast cancer.

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Breast Cancer: HOMING Study: Harvest of Circulating Tumor Cells (CTCs) from Patients with Metastatic Breast Cancer (MBC) using the Parsortix PC1 System

Lead Researcher: Richard Moore

If you participate in this study, you will be asked to allow the study doctor to draw 3 tubes of blood (up to a total of 23mL or 1 1/2 tablespoons of your blood) for the evaluation of the presence or absence of CTCs and their characterization as well as to collect information about your health.

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Breast Cancer: MK-3475 as Adjuvant therapy for Triple Receptor-Negative Breast Cancer or Positive Lymph Nodes After Neoadjuvant Chemotherapy - S1418

Lead Researcher: Alissa Huston

The purpose of this study is to compare treated subjects' invasive disease-free survival of patients with triple-negative breast cancer after neoadjuvant chemotherapy.

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Breast Cancer: Predictors of Chemotherapy Side Effects in Older Adults

Lead Researcher: Supriya Mohile

The purpose of this study is to understand how a person’s physical function (ability to complete daily activities at home and in the community) changes over time.

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Breast Cancer: Radiation Therapy with the Oral Drug Olaparib

Lead Researcher: Ajay Dhakal

This phase II trial studies how well radiation therapy with or without olaparib works in treating patients with inflammatory breast cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether radiation therapy with or without olaparib may work better in treating patients with inflammatory breast cancer.

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Cabozantinib S-Malate in Treating Patients With Neuroendocrine Tumors

Lead Researcher: Aram Hezel

This randomized phase III trial studies cabozantinib S-malate to see how well it works compared with placebo in treating patients with neuroendocrine tumors that have spread to nearby tissues or lymph nodes, have spread to other places in the body, or cannot be removed by surgery after previous treatment with everolimus. Cabozantinib S-malate is a chemotherapy drug known as a tyrosine kinase inhibitor, and it targets specific tyrosine kinase receptors, that when blocked, may slow tumor growth.

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Cancer (Geriatric): Cognitive Rehabilitation For At-Risk Older Cancer Patients Receiving Chemotherapy: A Pilot Study Evaluating Feasibility And Impact

Lead Researcher: Allison Magnuson

In Phase I all subjects will receive cognitive rehabilitation intervention which includes, workshops and at-home computer-based cognitive training. In the phase II portion of the study, depending on the group you are assigned, you may receive cognitive rehabilitation intervention or usual care. This will help researchers develop a doable approach to cognitive rehabilitation and see if it helps reduce the risk of developing progressive cognitive impairments which is a common side effect of chemotherapy.

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Cancer: Geriatric Assessment and Clinical Outcomes in Older Oncology Patients (SOCARE)

Lead Researcher: Supriya Mohile

We are asking for your participation in this study not as consent to undergo this testing (as it is undertaken for all new patients), but so that we may follow your evaluation results, and determine how this testing influences our shared decisions regarding your care and treatment. This information is useful, as it is understood that older patients (greater than or equal to 65-years old) often have different levels of health, and outside challenges that can influence their care. Historically, older patients have not received equal treatment for cancer and may be at greater risk for possible side effects from treatment. It is our hope that these tools, well-established at identifying areas of risk, will provide meaningful opportunities of intervention that will promote your safety.

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Cellular Dynamics at the Synovium Bone Interface in RA

Lead Researcher: Jennifer Anolik

You will be asked to have an ultrasound and a biopsy of your inflamed synovial tissue done. Synovial tissue is found in joints, like your knees, wrists and fingers, and creates synovial fluid, which helps lubricate your joint. Rheumatoid Arthritis (RA) causes the thin synovial tissue to become inflamed, leading to an accumulation of synovial fluid which causes swelling and pain.

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Collaborating with Caregivers

Lead Researcher: Aparajita Kuriyan

The purpose of this study is to understand the barriers that parents face when they seek mental health care for their children and to think about possible solutions.If you decide to take part in this study, you will be asked to complete 1 survey that will take about 10 minutes to complete. The survey is available online.

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Colorectal Cancer: Combination Chemotherapy, Bevacizumab, and/or Atezolizumab in Treating Patients With Deficient DNA Mismatch Repair Metastatic Colorectal Cancer

Lead Researcher: Marcus Noel

This study has 3 study groups. A computer will, by chance assign you to one of the groups in the study. This is done because no one knows if one study group is worse or better than the others. You will have an equal chance of being in groups 1, 2, or 3. Group 1 will get FOLFOX and bevacizumab, Group 2 will get atezolizumab alone and Group 3 will receive FOLFOX and bevacizumab plus atezolizumab. The drugs will be given by infusion.

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Colorectal Cancer: Regorafenib in Adults ≥ 70 Years with Metastatic Colorectal Cancer

Lead Researcher: Mohamedtaki Tejani

The standard treatment for metastatic colorectal cancer usually includes chemotherapy which can have side effects that are more difficult to tolerate for older patients with cancer. Regorafenib (a non-chemotherapy option) was recently approved by the FDA for treatment of patients whose cancer had grown on all standard chemotherapy agents. This study is being done among elderly patients, whose cancer has grown on all chemotherapy agents or who are not able to tolerate chemotherapy, to measure the safety of regorafenib in the elderly population and to assess how well the drug controls cancer growth.

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Colorectal Cancer: S1613, Trastuzumab and Pertuzumab or Cetuximab and Irinotecan Hydrochloride in Treating Patients With Locally Advanced or Metastatic HER2/Neu Amplified Colorectal Cancer That Cannot Be Removed by Surgery

Lead Researcher: Marcus Noel

If you decide to participate in this study a computer will assign you to one of the 3 study groups. This is done by chance because no one knows if one study group is better or worse than the other. Group 1 will receive the study drugs trastuzumab and pertuzumab. The combination of trastuzumab and pertuzumab is investigational (not approved by the FDA for treatment of colorectal cancer). These drugs will be given through a vein on Day 1 of every 21 day cycle. Group 2 will receive the usual chemotherapy, cetuximab and irinotecan, through a vein on Day 1 of every 14 day cycle. If you are in Group 2 and your cancer gets worse, you may have the option to receive the same treatment as Group 1, and be placed into Group 3.

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Combination Chemotherapy in Treating Young Patients With Newly Diagnosed High-Risk B Acute Lymphoblastic Leukemia and Ph-Like TKI Sensitive Mutations

This randomized phase III trial studies how well combination chemotherapy works in treating young patients with newly diagnosed B acute lymphoblastic leukemia that is likely to come back or spread, and in patients with Philadelphia chromosome (Ph)-like tyrosine kinase inhibitor (TKI) sensitive mutations. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) and giving the drugs in different doses and in different combinations may kill more cancer cells.

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Connect® MDS/AML Disease Registry

The purpose of the Connect® MDS/AML Disease Registry is to provide unique insights into treatment regimens and sequencing of these regimens as they relate to clinical outcomes of patients with newly diagnosed MDS, ICUS or AML in routine clinical practice and evaluate molecular and cellular markers that may provide further prognostic classification and/or might be predictive of therapy outcomes.

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Cooled Radiofrequency Ablation Study for Sacroliac Joint

Lead Researcher: Adam Carinci

This study will compare Coolief™ Cooled Radiofrequency Ablation of the sacroiliac joint to Standard Medical Management.

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Crizotinib in Treating Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been Removed by Surgery and ALK Fusion Mutations (An ALCHEMIST Treatment Trial)

This randomized phase III trial studies how well crizotinib works in treating patients with stage IB-IIIA non-small cell lung cancer that has been removed by surgery and has a mutation in a protein called anaplastic lymphoma kinase (ALK). Mutations, or changes, in ALK can make it very active and important for tumor cell growth and progression. Crizotinib may stop the growth of tumor cells by blocking the ALK protein from working. Crizotinib may be an effective treatment for patients with non-small cell lung cancer and an ALK fusion mutation.

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Darbepoetin Trial to Improve Red Cell Mass and Neuroprotection in Preterm Infants

Study Hypothesis: Preterm infants administered weekly Darbe during the neonatal period will have improved neurocognitive outcome at 22-26 months compared to placebo

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Daunorubicin and Cytarabine With or Without Uproleselan in Treating Older Adult Patients With Acute Myeloid Leukemia Receiving Intensive Induction Chemotherapy

Lead Researcher: Jane Liesveld

This phase II/III trial studies how well daunorubicin and cytarabine with or without uproleselan works in treating older adult patients with acute myeloid leukemia receiving intensive induction chemotherapy. Drugs used in chemotherapy, such as daunorubicin and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Uproleselan may prevent cancer from returning or getting worse. Giving daunorubicin and cytarabine with uproleselan may work better in treating patients with acute myeloid leukemia compared to daunorubicin and cytarabine alone.

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Dementia With Lewy Bodies: Effects of the drug Neflamapimod on cognition (thought processes)

Lead Researcher: Katherine Amodeo

This is a study of neflamapimod versus placebo . It will be administered with food for 16 weeks in participants with Dementia With Lewy Bodies. The primary objective is to evaluate the effect of neflamapimod on cognitive function (thought processes).

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Developmental Impact of NICU Exposures (DINE)

Lead Researcher: Gloria Pryhuber

The DINE study will test the hypothesis that potentially avoidable NICU-based exposures contribute to the neuro-cognitive and somatic impairments prevalent among NICU graduates. This hypothesis is drawn from the documented impact of phthalate exposure on early development in term-born children, and the acknowledged presence of these toxic chemicals in the NICU. Third trimester in utero exposure to phthalates have been linked to poorer childhood performance in cognition, motor function, attention, hyperactivity and social behavior. Phthalate exposure is also associated with altered onset of puberty and asthma. The multi-site cohort and approach will clarify the role of NICU-based phthalate exposure on high-prevalence clinical outcomes.

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Diffuse Large B Cell Lymphoma: A Study of PET Scan Adapted Therapy and Non-Invasive Monitoring

Lead Researcher: Carla Casulo

Measuring levels of circulating tumor DNA (ctDNA) in patients with early stage diffuse large B cell lymphoma (DLBCL), to assess the change in ctDNA during treatment in order to prospectively identify markers of treatment failure, and to use ctDNA as a future tool for response adapted therapy.

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Diffuse Large B-Cell Lymphoma (DLBCL): A Study of Brentuximab Vedotin Incorporated into Reduced-Dose Chemotherapy in Elderly Patients

Lead Researcher: Patrick Reagan

This study incorporates brentuximab vedotin into dose-reduced chemotherapy (rituximab, cyclophosphamide, doxorubicin, and prednisone) as initial therapy for elderly patients with Diffuse Large B-Cell Lymphoma (DLBCL). Vincristine, which is typically part of the standard chemotherapy regimen, will be omitted due to overlapping toxicities with brentuximab vedotin.

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DS-8201a Versus T-DM1 for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane [DESTINY-Breast03]

Lead Researcher: Alissa Huston

This study is designed to compare the anti-tumor activity as well as the safety and efficacy of DS-8201a versus T-DM1 in HER2-positive, unresectable and/or metastatic breast cancer subjects previously treated with trastuzumab and taxane

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Duration of Effect of Oral Spray in Patients With Dry Mouth Symptoms

Lead Researcher: Christine Lung

To determine the duration of effect of a single dose of an oral moisturizing spray in subjects who complain of a clinically dry mouth. The effect of the product will be compared to a standard therapy.

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Effects of Dexrazoxane Hydrochloride on Biomarkers Associated With Cardiomyopathy and Heart Failure After Cancer Treatment

Lead Researcher: Angela Girvin

This clinical trial studies the effects of dexrazoxane hydrochloride on biomarkers associated with cardiomyopathy and heart failure after cancer treatment. Studying samples of blood in the laboratory from patients receiving dexrazoxane hydrochloride may help doctors learn more about the effects of dexrazoxane hydrochloride on cells. It may also help doctors understand how well patients respond to treatment.

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Endometrial Cancer: Lenvatinib in Combination With Pembrolizumab Versus Treatment of Physician's Choice in Participants With Advanced Endometrial Cancer (MK-3475-775/E7080-G000-309 Per Merck Standard Convention [KEYNOTE-775])

Lead Researcher: Richard Moore

If you decide to participate in this study, you will be assigned by chance to get either lenvatinib plus pembrolizumab or doxorubicin or paclitaxel. You will know what treatment you will be assigned to receive.

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Ensartinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With ALK or ROS1 Genomic Alterations (A Pediatric MATCH Treatment Trial)

Lead Researcher: Angela Girvin

This phase II Pediatric MATCH trial studies how well ensartinib works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with ALK or ROS1 genomic alterations that have come back or do not respond to treatment and have spread to other places in the body. Ensartinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

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Erdafitinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With FGFR Mutations (A Pediatric MATCH Treatment Trial)

Lead Researcher: Angela Girvin

This phase II Pediatric MATCH trial studies how well erdafitinib works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders that have spread to other places in the body and have come back or do not respond to treatment with FGFR mutations. Erdafitinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

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Erlotinib Hydrochloride in Treating Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been Completely Removed by Surgery (An ALCHEMIST Treatment Trial)

This phase III ALCHEMIST trial studies how well erlotinib hydrochloride compared to observation works in treating patients with stage IB-IIIA non-small cell lung cancer that has been completely removed by surgery. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

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Essential Thrombocythemia: Phase 2 Study of Ruxolitinib Versus Anagrelide in Subjects With Essential Thrombocythemia Who Are Resistant to or Intolerant of Hydroxyurea (RESET-272)

Lead Researcher: Frank Akwaa

This study has two groups. The first group, Group A, will be treated with ruxolitinib and placebo and the second group, Group B, will be treated with anagrelide and placebo. You will be randomly assigned (like flipping a coin) to Group A or Group B. Neither you nor your Study Doctor can identify which group you will be assigned to. You will have equal chance of receiving ruxolitinib or anagrelide.

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Evaluating Social Networks for Adults with Advanced Cancer: A Pilot Feasibility Study

Lead Researcher: Supriya Mohile

The purpose of this study is to learn how older adults with cancer seek information from their social networks (family, friends, clergy, or other people they are close with) and how they use information they’ve gathered to make decisions about treatment for their cancer.

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Evaluating URMC's Massive Transfusion Protocol

Lead Researcher: Majed Refaai

The purpose of the study is to evaluate the efficacy of the University of Rochester Medical Center's current Massive Transfusion Protocol. Upon arrival of trauma level one designated patients the treating team evaluates the patient's injuries. If the patient is initiated under the facilities Massive Transfusion Protocol and meets other inclusion and exclusion criteria the patient will be enrolled in the study. Study procedures include collection of a blood sample following the transfusion of each shipment, through shipment 5, of blood products outlined in the current Massive Transfusion Protocol. Each blood sample will be run on a Thromboelastograph to evaluate the patient's hematostatic state through resuscitation. One final blood sample will be collected 24 hours following the discontinuation of the Massive Transfusion Protocol and also ran on the thromboelastograph. Due to the critical need for medical intervention, consent procedure will be waived at time of enrollment. An authorized representative for the patient will be identified and approached to obtain consent for use of data collected.

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Follow-up Visit of High Risk Infants

The NICHD Neonatal Research Network's Follow-Up study is a multi-center cohort in which surviving extremely low birth-weight infants born in participating network centers receive neurodevelopmental, neurosensory and functional assessments at 22-26 months corrected age (Infants born prior to July 1, 2012 were seen at 18-22 months corrected age). Data regarding pregnancy and neonatal outcome are collected prospectively. The goal is to identify potential maternal and neonatal risk factors that may affect infant neurodevelopment.

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Gastric & Gastroesophageal Cancer: A Study of FPA144 Combined With Modified FOLFOX6 in Gastric/Gastroesophageal Cancer (FIGHT)

Lead Researcher: Mohamedtaki Tejani

This study consists of 2 phases. The first phase (Phase 1) of the study will be open to patients who have gastrointestinal cancer and plan to receive a type of chemotherapy treatment called mFOLFOX6. The second phase (Phase 3) will include patients who have gastric or gastroesophageal cancer, whose physician plans to administer chemotherapy (mFOLFOX6) as therapy, and have a tumor that is FGFR2b positive.

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Gastric or Gastroesophageal Junction: Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants With Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-585/KEYNOTE-585)

Lead Researcher: Mohamedtaki Tejani

If you decide to participate in this research study, your study doctor will assign you to one of three chemotherapy treatments: XP (cisplatin and capecitabine), FP (cisplatin and 5-FU) or FLOT (docetaxel, oxaliplatin, 5-FU and leucovorin). Once you are assigned a chemotherapy treatment, you will be assigned by chance to receive either chemotherapy + pembrolizumab before and after surgery followed by pembrolizumab only or chemotherapy + placebo (look-alike with no active ingredients) before and after surgery followed by placebo only. You may still be able to continue in the study if you are unable to have or no longer need surgery. The study doctor will discuss this with you. You will be assigned by chance to get either pembrolizumab or placebo (a look alike with no active ingredients). You have a 1 in 2 chance of getting placebo only. Neither you nor the study doctor will know if you are receiving pembrolizumab or placebo.

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Gastrointestinal (pancreas) Cancer: Glufosfamide Versus 5-FU in Second Line Metastatic Pancreatic Cancer

Lead Researcher: Marcus Noel

Glufosfamide is being compared against Fluorouracil (5-FU). Fluorouracil is approved by the FDA for use in people with rectal cancer. 5-FU was the drug of choice for pancreatic cancer before gemcitabine and is still used in multiple regimens such as folfox and Folfirinox as part of standard of care. The study drug is made of glucose (a sugar made by the body) and a substance which damages or kills cancer cells. Cancer cells depend on sugar more than normal cells do, so the cancer cells may take up more of the study drug than normal cells. This may allow glufosfamide to attack the cancer cells without causing excessive damage to the normal cells.

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General Anesthetics in CAncer REsection Surgery (GA-CARES) Trial

Lead Researcher: Jacob Nadler

This is a large pragmatic multicenter trial comparing maintenance of general anesthesia with total intravenous anesthesia using propofol versus volatile agent (sevoflurane, isoflurane, or desflurane) during cancer surgery. The primary endpoint is all-cause mortality.

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Generic Database of Very Low Birth Weight Infants

The Generic Database (GDB) is a registry of very low birth weight infants born alive in NICHD Neonatal Research Network (NRN) centers. The GDB collects observational baseline data on both mothers and infants, and the therapies used and outcomes of the infants. The information collected is not specific to a disease or treatment (i.e., it is "generic"). Data are analyzed to find associations and trends between baseline information, treatments, and infant outcome, and to develop future NRN trials.

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Genetic Testing in Screening Patients With Stage IB-IIIA Non-Small Cell Lung Cancer That Has Been or Will Be Removed by Surgery (The ALCHEMIST Screening Trial)

This phase III ALCHEMIST trial studies genetic testing in screening patients with stage IB-IIIA non-small cell lung cancer that has been or will be removed by surgery. Studying the genes in a patient's tumor cells may help doctors select the best treatment for patients that have certain genetic changes.

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Guaraná and Cancer-Related Fatigue

Lead Researcher: Julia Inglis

This is a six-week study through the Cancer Control unit in the Department of Surgery. This study will recruit cancer survivors (4-36 months post-treatment) and randomly assign them to three arms: 1) eats a guaraná energy bar twice a day, once in the morning and once at lunch-time. 2) eats a guaraná energy bar once a day only, in the morning. 3) usual-care only, completes entire study without eating the guaraná energy bars during study but receives 'usual-care' for cancer survivors. The three arms will all be assessed for cancer-related fatigue, mood, cognition, physical performance, blood glucose changes, blood glutamine levels and inflammatory markers at the start of the study and at the final visit. Cancer-related fatigue levels will also be assessed at the midpoint visit.

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Gynecologic (cervical) cancer: Radiation Therapy With or Without Chemotherapy in Patients With Stage I or Stage II Cervical Cancer Who Previously Underwent Surgery

Lead Researcher: Richard Moore

You will get either standard treatment with radiation therapy OR standard treatment with radiation therapy with the addition of cisplatin chemotherapy.

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Hairy Cell Leukemia: Quality of Life and Clinical Outcomes of Hairy Cell Leukemia Patients: A Longitudinal Study

Lead Researcher: Clive Zent

If you decide to participate in this study, you will be asked to complete a quality of life questionnaire every 6 months, either in clinic, online or in your home. This survey will take approximately 45 minutes to 1 hour to complete.

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Head and Neck Cancer: Radiation Therapy With or Without Cisplatin in Treating Patients With Stage III-IV Squamous Cell Carcinoma of the Head and Neck Who Have Undergone Surgery

Lead Researcher: Ronald Maggiore

The purpose of this study is to compare two treatment approaches that are currently used after surgery for head and neck cancer. One approach is to administer radiation therapy alone. A second approach is to administer radiation therapy along with the chemotherapy drug, cisplatin.

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Hematopoietic Stem Cell Transplantation: Evaluation of Investigational Cryopreserved Cord Blood Units (CBUs)

Lead Researcher: Omar Aljitawi

The purpose of this study is to document and evaluate all problems that may occur with the use of investigational cord blood units. This study will evaluate the safety of administration of the investigational cord blood units by carefully documenting all infusion-related problems. The cord blood units in this study have been collected, processed, tested and stored by the National Cord Blood Program and meet the criteria for transplantation as approved by NetCord-FACT (Foundation for the Accreditation of Cellular Therapy).

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Herpes Zoster Vaccine in Patients with Chronic Lymphocytic Leukemia and Waldenström Macroglobulinemia

Lead Researcher: Jonathan Friedberg

The purpose of this study is to measure humoral response 4 weeks after vaccination with the Shingrix herpes zoster vaccine in patients with CLL and WM undergoing first-line treatment with BTK inhibitors.

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HOPE-Helping Older People Engage

Lead Researcher: Kimberly Van Orden

The purpose of this study is to compare two activities — reflecting on one’s past (called “life review”) and volunteering in the community (“volunteering”). We are interested in learning how these activities may improve social connectedness and well-being among adults age 60 and older. Volunteering involves participate weekly in a flexible volunteer program with Lifespan that involves a menu of options including helping at senior centers, co-leading classes, mentoring/tutoring and many other options. Life review involves participating in a one-year reminiscence program that is self-guided and involves completing monthly exercises such as writing about one’s memories.

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Hydrocortisone for premature babies

Lead Researcher: Carl D'Angio

The Hydrocortisone and Extubation study will test if giving hydrocortisone for 10 days improves survival for premature infants who have a breathing tube. Infants will either receive hydrocortisone or placebo.

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Ibrutinib and Obinutuzumab With or Without Venetoclax in Treating Older Patients With Untreated Chronic Lymphocytic Leukemia

Lead Researcher: Paul Barr

This phase III trial studies how well ibrutinib and obinutuzumab with or without venetoclax work in treating older patients with untreated chronic lymphocytic leukemia. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with obinutuzumab, may induce changes in body's immune system and may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as venetoclax work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ibrutinib and obinutuzumab with venetoclax may work better at treating chronic lymphocytic leukemia compared to ibrutinib and obinutuzumab.

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Ibrutinib and Obinutuzumab With or Without Venetoclax in Treating Patients With Chronic Lymphocytic Leukemia

Lead Researcher: Paul Barr

This phase III trial studies how well ibrutinib and obinutuzumab with or without venetoclax work in treating patients with chronic lymphocytic leukemia. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as obinutuzumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as venetoclax, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ibrutinib, obinutuzumab and venetoclax may work better in treating patients with chronic lymphocytic leukemia.

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Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

Lead Researcher: Angela Girvin

This randomized phase III trial studies how well imatinib mesylate and combination chemotherapy work in treating patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia. Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving imatinib mesylate and combination chemotherapy may work better in treating patients with Philadelphia chromosome positive acute lymphoblastic leukemia.

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Immunotherapy (Nivolumab or Brentuximab Vedotin) Plus Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III-IV Classic Hodgkin Lymphoma

Lead Researcher: Jonathan Friedberg

This randomized phase III trial compares immunotherapy drugs (nivolumab or brentuximab vedotin) when given with combination chemotherapy in treating patients with newly diagnosed stage III or IV classic Hodgkin lymphoma. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Brentuximab vedotin is a monoclonal antibody, brentuximab, linked to a toxic agent called vedotin. Brentuximab attaches to cancer cells in a targeted way and delivers vedotin to kill them. Drugs used in chemotherapy, such as doxorubicin, vinblastine, and dacarbazine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The addition of nivolumab or brentuximab vedotin to combination chemotherapy may shrink the cancer or extend the time without disease symptoms coming back.

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Immunotherapy + Radiation in Resectable Soft Tissue Sarcoma

Lead Researcher: Deepak Sahasrabudhe

Immunotherapy + Radiation in Resectable Soft Tissue Sarcoma

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Impact of CD34+ Cell Dose on Progression-free Survival Following High-Dose Therapy and Autologous Stem Cell Transplantation for Relapsed and Refractory Diffuse Large B-cell Lymphoma (DLBCL)

Lead Researcher: Michael Becker

Following enrollment, patients will be CD34+ stem cell mobilized with plerixafor, at the discretion of the treating attending physician, for the achievement of >6 x10^6 CD34+ cells/kg. The patients that fail to mobilize >6 x10^6 CD34+ cells/kg will not be randomized and will subsequently be followed for disease progression and overall survival. Patients with >6 x10^6 CD34+ cells/kg cryopreserved on study will be admitted to the hospital for planned autologous stem cell transplant (ASCT). Patients will be randomly infused with either 3-4 x 10^6 CD34+ stem cells/kg or 6-8 x10^6 CD34+ stem cells/kg. Patients will receive standard supportive measures (including: growth factor support post-HDT/ASCT, antimicrobial prophylaxis, red blood cell and platelet transfusion and treatment for neutropenic fever) as per institutional guidelines.

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Improving Risk Assessment of Acute Myeloid Leukemia (AML) With a Precision Genomic Strategy to Assess Mutation Clearance

Lead Researcher: Eric Huselton

The investigators will prospectively determine whether the relapse-free and overall survival in patients who have cleared their leukemia-associated mutations treated with standard consolidation chemotherapy is superior to what is expected based on historical controls. The investigators will also prospectively determine the relapse-free and overall survival of patients who have not cleared their mutations. Because the relapse rate of patients with persistent mutations is expected to be high, treatment with either standard of care consolidation therapy alone or alloSCT will be permitted, at the discretion of the treating physician.

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Improving Well-Being for Older Adult Family Dementia Caregivers

Lead Researcher: Kathi Heffner

The purpose of the study is to examine the effects of the Mindfulness-Based Stress Reduction (MBSR) program and the Living Well (LW) for Dementia Caregivers program, compared to any usual care, to see if the programs might be associated with better immune function, physical and emotional health, and well-being. This study is looking for individuals age 55 and up who are caring for a loved one (such as a spouse, parent, close friend) who has dementia. Participation includes attending a weekly small group meeting over eight weeks for one of two study programs (determined randomly). Both programs address ways of improving physical and emotional well-being in the context of dementia caregiving. These 8-week programs typically begin in late August at Monroe Community Hospital.

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Individualized Treatment in Treating Patients With Stage II-IVB Nasopharyngeal Cancer Based on EBV DNA

There are two study questions we are asking in this randomized phase II/III trial based on a blood biomarker, Epstein Barr virus (EBV) deoxyribonucleic acid (DNA) for locoregionally advanced non-metastatic nasopharyngeal cancer. All patients will first undergo standard concurrent chemotherapy and radiation therapy. When this standard treatment is completed, if there is no detectable EBV DNA in their plasma, then patients are randomized to either standard adjuvant cisplatin and fluorouracil chemotherapy or observation. If there is still detectable levels of plasma EBV DNA, patients will be randomized to standard cisplatin and fluorouracil chemotherapy versus gemcitabine and paclitaxel. Radiation therapy uses high energy x rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, fluorouracil, gemcitabine hydrochloride, and paclitaxel work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving cisplatin and fluorouracil is more effective than gemcitabine hydrochloride and paclitaxel after radiation therapy in treating patients with nasopharyngeal cancer.

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Induction Chemotherapy for Locally Advanced Esophageal Cancer

Lead Researcher: Richard Dunne

Evaluate mFOLFOX6 (5-Fluorouracil, Leucovorin and Oxaliplatin) chemotherapy as induction treatment prior to standard neoadjuvant chemoradiation to decrease the rate of distant recurrence among patients with locally advanced esophageal cancer.

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Infant Allergy Study

Lead Researcher: Kirsi Jarvinen-seppo

The purpose of this study is to provide new knowledge about the development of infant immunity, and set the groundwork for future studies in the prevention of allergic diseases in childhood. We can study the difference between populations with allergic diseases and those without allergic diseases by comparing breast milk, saliva, blood, skin swab, nasal swab, urine, and stool samples.

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Larotrectinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With NTRK Fusions (A Pediatric MATCH Treatment Trial)

Lead Researcher: Angela Girvin

This phase II Pediatric MATCH trial studies how well larotrectinib works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with NTRK fusions that have spread to other places in the body and have come back or do not respond to treatment. Larotrectinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

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Leukemia (ALL): Blinatumomab and Combination Chemotherapy or Dasatinib, Prednisone, and Blinatumomab in Treating Older Patients With Newly Diagnosed Acute Lymphoblastic Leukemia (ALL)

Lead Researcher: Kristen O'Dwyer

This study will have 2 groups: subjects who do not have the Philadelphia chromosome mutation (Ph-) and subjects who do have the mutation (Ph+). Treatments for the two groups will be different and are outlined below. In general, there are 3 main steps to all of the treatments. Induction/Re-Induction treatment is given first. It is a treatment given over a short period of time (usually only a few months) to get rid of as many of the leukemia cells as possible very quickly. Post-Remission treatment is given next. It is given to get rid of any leukemia cells that are left once your leukemia goes into remission and to make sure the leukemia cells don’t come back over a short period of time (usually only a few months). Maintenance treatment is given last. It is a lower dose treatment given over a long period of time (up to several years) to help keep the leukemia cells from coming back. Depending on which arm of the study you are on, Blinatumomab will be given as part of induction/re-induction or post-remission along with standard chemotherapy.

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Leukemia (AML & MDS): Connect® MDS and AML: The Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML) Disease Registry

Lead Researcher: Jason Mendler

This study is observational. An observational disease registry study means that only information about your disease and medical treatment that your study doctor is already prescribing as part of your standard medical care is collected. Standard medical care is the treatment normally given for a certain condition or illness. You will continue with your standard medical care and continue with any medicines you are now taking, office visits and laboratory testing according to the normal routine practices of your treating or study doctor(s). No additional medication, or payment for medication, is provided as part of this study. There is no investigational drug involved in this study. There will be no additional study visits, procedures, or testing required for this study. We will only collect this information as it relates to the standard medical care you are receiving. If you give your consent to participate in this study, your study doctor will inform your treating doctor(s), if applicable, that you are taking part in this study.

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Leukemia (AML & MDS): Azacitidine With or Without Nivolumab or Midostaurin, or Decitabine and Cytarabine Alone in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome

Lead Researcher: Kristen O'Dwyer

If you participate in this study you will randomly be assigned to one of the following treatment groups; Group A: azacitidine alone, Group B: azacitidine and nivolumab, or Group C: azacitidine and midostaurin. The cycles for all study groups will repeat until your disease gets worse or you or your study doctor decide you should stop. Each cycle is 28 days.

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Leukemia (AML): Ivosidenib Expanded Access Program in Relapsed/Refractory AML With an IDH1 Mutation

Lead Researcher: Jason Mendler

This is an expanded access program. The program is sponsored by the pharmaceutical company named Agios Pharmaceuticals, Inc. (the "Sponsor"). The purpose of this EAP is to provide access to ivosidenib to qualifying patients during the period of time prior to the potential approval and commercial availability of ivosidenib.

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Leukemia Treatment: Adding an Antibody to Front-Line Chemotherapy

Lead Researcher: Kristen O'Dwyer

Monoclonal antibodies, such as inotuzumab ozogamicin, may block cancer growth in different ways by targeting certain cells. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving inotuzumab ozogamicin with chemotherapy may work better in treating young adults with B acute lymphoblastic leukemia. This trial studies the side effects of inotuzumab ozogamicin and how well it works when given with front-line chemotherapy in treating patients with newly diagnosed B acute lymphoblastic leukemia.

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Leukemia: A program for monitoring minimal residual disease following treatment of patients with Acute Myeloid Leukemia or High Grade Myelodysplastic Syndrome.

Lead Researcher: Michael Becker

This study is being performed to develop better tests to determine the impact of the therapy you are receiving for treatment of your AML or MDS and to determine if these tests can identify those patients who are at a greater risk for having their disease relapse. Following therapy, the majority of patients with AML and many patients with MDS will achieve a remission that is defined by the lack of any evidence of the disease when viewing bone marrow samples under a microscope. Despite the absence of disease by this method, many patients in remission will still have what is referred to as Minimal Residual Disease when more sensitive methods are applied. That is, even though the disease cannot be seen by routine staining under the microscope, more sensitive tests can detect its presence. The presence of Minimal Residual Disease following therapy does not guarantee that the patient will experience a relapse. This is likely a result of the failure of these techniques to examine those cells that are responsible for disease relapse. Recent data suggests that in the majority of patients with AML or MDS only a minor population of the malignant cells are capable of maintaining the disease and are likely responsible for relapse following therapy. This minor population of cells can be identified by the proteins they have on their surface. This study tests the ability to identify Minimal Residual Disease following therapy by performing special assays that specifically target this minor population of malignant cells.

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Leukemia: Characterization of the bone marrow microenvironment in patients with myelodysplastic syndrome (MDS)

Lead Researcher: Michael Becker

This study is being performed to begin to understand the interactions between MDS tumor cells and the normal bone marrow supporting cells, termed the bone marrow microenvironment.

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Leukemia: Combination Chemotherapy With or Without Blinatumomab in Treating Patients With Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia (ALL)

Lead Researcher: Kristen O'Dwyer

Studies are being done in ALL and other blood cancers with blinatumomab. It is hoped that blinatumomab will target your B-cell ALL and destroy these specific cells, but it has not yet been proven.

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Leukemia: Phase I Testing the Addition of Inotuzumab Ozogamicin, to Usual Chemotherapy in Relapsed and Refractory Acute Leukemia

Lead Researcher: Michael Becker

The purpose of this study is to test the safety of the experimental drug inotuzumab ozogamicin at different doses to find out what effects, if any, it has on people. The researchers also want to determine the effects, good and/or bad, of adding inotuzumab ozogamicin to regular chemotherapy with cyclophosphamide, vincristine and prednisone (CVP). While researchers hope that adding inotuzumab ozogamicin will be a better treatment, there is no proof of this.

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Long-term Study in US Cystic Fibrosis Patients Receiving Digestive Enzyme Supplements to Assess Narrowing of the Large Intestine Causing Adverse Intestinal Symptoms (Fibrosing Colonopathy)

This is a long-term study in cystic fibrosis patients who are participating in the Cystic Fibrosis Patient Registry to assess the occurrence and risk factors for a rare bowel disorder called fibrosing colonopathy (narrowing of the large intestine). Patients will be followed at their regular clinical care visits over a 10-year period and approached if they develop symptoms of fibrosing colonopathy for collection and use of further detailed information.

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Lung Cancer (NSCLC): A Dose Escalation Study Of PF-06801591 In Melanoma, Head And Neck Cancer (SCCHN), Ovarian, Sarcoma, Non-Small Cell Lung Cancer, Urothelial Carcinoma or Other Solid Tumors

Lead Researcher: Megan Baumgart

There are 2 parts to this study: dose escalation (Part 1) and dose expansion (Part 2). For Part 1, different doses and types of administration of PF-06801591 were tested and the information gathered was used to determine the optimal dosing regimen for further evaluation in Part 2. This study is currently open to Part 2; you will receive the investigational drug, PF06801591 every 28 days.

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Lung Cancer (NSCLC): A Study Of Lorlatinib Versus Crizotinib In First Line Treatment Of Patients With ALK-Positive NSCLC

Lead Researcher: Megan Baumgart

If you participate in this research study, you will be assigned by chance (like flip of a coin or drawing straws) to receive either lorlatinib alone (Group A) or crizotinib alone (Group B). You will have a 50% (1 in 2) chance of receiving lorlatinib, and a 50% (1 in 2) chance of receiving crizotinib. Neither you nor your doctor can choose the group you will be in.

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Lung Cancer (NSCLC): Expanded Access For Lorlatinib For Patients With Non Small Cell Lung Cancer Carrying an ALK or ROS1 Rearrangement

Lead Researcher: Deborah Mulford

This is an expanded access program. The program is sponsored by the pharmaceutical company named Pfizer, Inc. (the "Sponsor"). The purpose of this program is to allow patients with advanced non-small cell lung cancer access to lorlatinib treatment and to find out the good and bad effects of this drug.

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Lung Cancer: Cisplatin/Carboplatin and Etoposide With or Without Nivolumab in Treating Patients With Extensive Stage Small Cell Lung Cancer

Lead Researcher: Megan Baumgart

If you decide to participate in this study you will be assigned to one of the two treatment groups by chance. This is done by chance because no one knows if one study group is better or worse than the other. Group 1 will receive the study drug nivolumab in combination with the usual chemotherapy regimen of platinum (cisplatin or carboplatin) and etoposide administered by an intravenous (IV) infusion. Group 2 will receive the usual chemotherapy alone administered by an intravenous (IV) infusion.

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Lung Cancer: First-Line Treatment of M7824 Versus Pembrolizumab

Lead Researcher: Deborah Mulford

The study will evaluate M7824 monotherapy versus pembrolizumab as first-line treatment for participants with advanced non-small-cell lung carcinoma (NSCLC) with high PD-L1-tumor expression (PD-L1 stand for Programmed Death-Ligand 1).

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Lung Cancer: VX15/2503 in Combination With Avelumab in Advanced Non-small Cell Lung Cancer (CLASSICAL-Lung)

Lead Researcher: Megan Baumgart

There are 2 phases in this study. If you are in the dose finding phase of the study, the dose level of VX15/2503 that you receive is depends on when you enter the study. The first group of subjects in this study will get a low dose of VX15/2503. If that dose is well tolerated by those subjects, then the next group of subjects will get a higher dose of VX15/2503. This will continue until the highest tolerable, safe dose of VX15/2503 is reached. The dose expansion phase will begin begin after the highest tolerable dose, or recommended phase 2 dosage (dose to be tested in expansion), has been identified in the dose finding phase of the trial.

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Lung-MAP Screening Study

Lead Researcher: Megan Baumgart

The purpose of this study is to find out if a targeted or immunotherapy treatment will have an effect on specific genes and proteins in a tumor.

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Lymphoma & Leukemia: Collection of specimens and epidemiological and clinical outcomes data in patients with hematological malignancies

Lead Researcher: Walter Burack

This research is being done because we hope that a better understanding of hematologic malignancies will allow us to develop new and better treatments.

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Lymphoma (Bone Marrow Transplant): Ibrutinib Before and After Stem Cell Transplant in Treating Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma

Lead Researcher: Michael Becker

This study has two treatment groups: Group 1: For the first 6 days, you will get the usual chemotherapy (BEAM or CBV), plus the study drug ibrutinib. Then, you will receive ibrutinib for 12 months following AutoHCT. Group 2: For the first 6 days, you will get the usual chemotherapy (BEAM or CBV), plus a placebo (a pill that looks like the study drug but contains no medication). Then, you will receive a placebo for 12 months following AutoHCT. However, if you were to progress or relapse while taking the placebo, you would be offered treatment with the study drug, ibrutinib, at that time. The researchers want to know if adding ibrutinib to the usual chemotherapy given with AutoHCT could prevent your lymphoma from returning in the future. However, the addition of this medication could also cause side effects that the researchers want to know about.

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Lymphoma (Diffuse Large B Cell): A Study Evaluating the Efficacy of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma (DLBCL) (ZUMA-7)

Lead Researcher: Patrick Reagan

If you decide to participate in this study, you will be randomized or assigned to one of two study groups based on your previous response to therapy and the International Prognostic Index score, a tool used to predict the likely course of your disease. The Experimental Treatment Group will undergo collection of white blood cells by a process called leukapheresis in order to manufacture your T cells into axi-cel, three days of conditioning chemotherapy, and a single infusion of axi-cel. If your Study Doctor believes the current status of your disease is rapidly progressing, you may receive steroid therapy while axi-cel is being manufactured. The Standard of Care (SOC) Treatment Group will receive standard of care therapies including two or three cycles of second-line platinum-based combination chemotherapy regimens with rituximab; R-ICE (Rituximab, Ifosfamide, Carboplatin, Etoposide), R-DHAP (Rituximab, Dexamethasone, High-dose Cytarabine, Platinum) R-ESHAP (Rituximab, Etoposide, Methylprednisolone, Cytarabine, Cisplatin) or R-GDP (Rituximab, Gemcitabine, Dexamethasone, Platinum), as selected by your Study Doctor. If your cancer responds to the chemotherapy treatment, you will also receive high dose therapy and ASCT per your Study Doctor.

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Lymphoma (DLBCL): A Study Comparing the Efficacy & Safety of Polatuzumab Vedotin w/ Rituximab-Cyclophosphamide, Doxorubicin, and Prednisone vs Rituximab-Cyclophosphamide, Doxorubicin, Vincristine, & Prednisone in Diffuse Large B-Cell Lymphoma (POLARIX)

Lead Researcher: Patrick Reagan

If you decide to participate in this study you will be randomly assigned by a computer program to one of the following treatment groups: polatuzumab vedotin and R-CHP with placebo, or R-CHOP with placebo. Since the difference between the treatment groups is polatuzumab vedotin in one group and vincristine (O) in the other, both groups will receive a placebo, which is a substance that looks like either polatuzumab vedotin or vincristine but contains no active medication. Neither you nor your study doctor may choose the group that you will be in. You will have an equal chance of being placed in either group. Neither you nor your study doctor will know which treatment you receive.

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Lymphoma (Follicular Lymphoma (FL)): Pilot Study to Evaluate Circulating Tumor DNA in Follicular Lymphoma

Lead Researcher: Paul Barr

If you are eligible and agree to participate in this research study the following will occur: Stored tumor tissue from a previous biopsy will be collected to look at genomic changes in your tumor tissue. Blood collection; about 4 teaspoons of blood will be collected up to 4 times during your routine clinic visits to look at tumor genetic changes over time.

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Lymphoma (iNHL): A Study to Evaluate the Effect of Vitamin D on PFS in Indolent Non-Hodgkin's Lymphoma (ILyAD)

Lead Researcher: Jonathan Friedberg

If you decide and are eligible to take part in this study, in addition to the standard treatment, rituximab, you will be randomized to receive an oral dose of either 2,000 IU vitamin D (also called cholecalciferol) supplementation or placebo. The randomization will be 2:1. A 2:1 randomization means for every three people enrolled on the study, two people will receive vitamin D and one person will receive placebo. This study is conducted in a double blind fashion, which means neither you nor your doctor will know which treatment group you are in.

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Lymphoma/Leukemia (CLL/SLL): A Study Comparing BGB-3111 With Bendamustine Plus Rituximab in Patients With Previously Untreated CLL or SLL

Lead Researcher: Paul Barr

If you decide to participate in this study; as part of the screening tests for the study, your blood will be tested to determine whether you have CLL/SLL that has a mutation (a change) in one of the chromosomes called ‘17p deletion’. If you have CLL/SLL that does not have the 17p deletion, you will be in Cohort 1 and will be randomly assigned by a computer program to one of the following treatment groups in Cohort 1: BGB-3111 or B+R. When you are “randomly assigned” it means you are put into a group by chance, like flipping a coin. Neither you nor your study doctor may choose the treatment you will take. You will have an equal chance of receiving either treatment in Cohort 1. If your CLL/SLL has the 17p deletion, you will be assigned to Cohort 2 and will receive BGB-3111.

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Lymphoma: A Phase 1-2 Dose-Escalation and Cohort-Expansion Study of Oral eFT508 in Subjects With Hematological Malignancies

Lead Researcher: Paul Barr

This research study has two parts. Part 1 will test the safety and tolerability of the study drug at different doses and using different ways of taking the drug (powder mixed with a liquid diluent [suspension] taken once per day or capsules taken once or twice per day) to determine the recommended dose. Part 2 will test what effects the study drug has on the cancer and the safety of the study drug when given at the recommended dose.

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Lymphoma: A Safety and Efficacy Study of Nivolumab in Combination With Brentuximab Vedotin to Treat Non-Hodgkin Lymphomas

Lead Researcher: Paul Barr

The purpose of this study is to test the effectiveness (how well the drug works), safety, and tolerability of an investigational drug called nivolumab (also known as BMS-936558) in combination with brentuximab vedotin. Nivolumab is an antibody (a type of human protein) that is being tested to see if it will allow the body’s immune system to work against tumor cells. Brentuximab vedotin is an antibody-drug conjugate (a type of human protein linked to a study drug). The antibody part of the drug binds to CD30 which often occurs on diseased cells but rarely on normal tissues.

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Lymphoma: Brentuximab vedotin and involved site radiotherapy in newly diagnosed, unfavorable risk Hodgkin lymphoma.

Lead Researcher: Carla Casulo

Early stage, high risk HL has a chance of coming back after standard treatment. The best treatment for early stage, high risk HL is chemotherapy followed by radiation. The chemotherapy is called ABVD and has four drugs approved by the Food and Drug Administration (FDA): doxorubicin, bleomycin, vinblastine, and dacarbazine. This is a pilot phase II study of a new treatment plan for your HL. The treatment consists of a new drug, brentuximab vedotin (BV), combined with adriamycin, vinblastine, and dacarbazine (AVD) chemotherapy followed by radiation. The purpose of this study is to find out whether BV with AVD chemotherapy and radiation is a safe and effective treatment. BV is a type of drug called an antibody drug conjugate. BV has 2 parts; a part that targets cancer cells (the antibody) and a cell killing part (the chemotherapy). The antibody part of BV sticks to a target called CD30. CD30 is an important molecule on HL cancer cells and some normal cells of the immune system. The cell killing part of BV is a chemotherapy called monomethyl auristatin E (MMAE). It can kill cells that the antibody part of BV sticks to.

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Maintenance Chemotherapy or Observation Following Induction Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Ependymoma

Lead Researcher: Angela Girvin

This partially randomized phase III trial is studying maintenance chemotherapy to see how well it works compared to observation following induction chemotherapy and radiation therapy in treating young patients with newly diagnosed ependymoma. Drugs used in chemotherapy, such as vincristine sulfate, carboplatin, cyclophosphamide, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving chemotherapy with radiation therapy may kill more tumor cells and allow doctors to save the part of the body where the cancer started.

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Maintenance Chemotherapy With or Without Stereotactic Body Radiation Therapy in Treating Patients With Stage IV Non-small Cell Lung Cancer

This randomized phase II/III trial studies how well giving maintenance chemotherapy with or without stereotactic body radiation therapy works in treating patients with stage IV non-small cell lung cancer. Drugs used in maintenance chemotherapy, such as docetaxel, pemetrexed disodium, and gemcitabine work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays directly to the tumor using smaller doses over several days and may cause less damage to normal tissue. Giving maintenance chemotherapy and stereotactic body radiation therapy together may work better than maintenance chemotherapy alone in treating patients with stage IV non-small cell lung cancer.

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Management of the PDA Trial

Patent ductus arteriosus (PDA) is an extra blood vessel found in babies before birth and just after birth. In most babies who have an otherwise normal heart, the PDA will shrink and close on its own in the first few days of life. If it stays open longer, it may cause extra blood to flow to the lungs. This study estimates the risks and benefits of active treatment versus expectant management of premature babies with patent ductus arteriosus.

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Management of Tobacco Treatment Intervention in Reducing Surgical Complications in Patients With Newly Diagnosed Lung Cancer Who Smoke Cigarettes

Lead Researcher: Michal Lada

This randomized phase III trial studies how well management of a tobacco treatment intervention works in reducing surgical complications in patients with newly diagnosed lung cancer who smoke cigarettes. Management of a tobacco treatment intervention compares varenicline (a drug that reduces the craving and withdrawal symptoms that occur with abstinence from nicotine) and behavioral interventions (consisting of a brief clinician-delivered intervention and tobacco quitline [tobacco cessation service available through a toll-free telephone number] follow-up) with placebo (a pill with no active medication) along with similar behavioral interventions. It is not yet known whether management of a tobacco treatment intervention is more effective in reducing surgical complications than placebo.

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Measuring Surgical Recovery After Radical Cystectomy

The intent of this study is to establish a registry of post‐surgical outcomes in patients undergoing radical cystectomy. The goals of this initiative are to obtain a detailed baseline of multiple patient‐reported outcomes (PRO) and clinician‐reported outcomes (CRO) as well as various presenting conditions associated with them, so that future quality improvement interventions can be evaluated accurately as to their relative contribution to improved outcomes.

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Melanoma: Dabrafenib and Trametinib Followed by Ipilimumab and Nivolumab or Ipilimumab and Nivolumab Followed by Dabrafenib and Trametinib in Treating Patients With Stage III-IV BRAFV600 Melanoma

Lead Researcher: Deepak Sahasrabudhe

The BRAF inhibitor component will include two drugs dabrafenib and trametinib that each have been approved by the FDA for the treatment of this patient population and have also been approved for use in combination due to superior effects relative to the single agent treatments. In addition, the study will involve the addition of the FDA approved agent nivolumab to the standard FDA approved ipilimumab immunotherapy in the hopes that it might further improve the good effects of the immunotherapy component of the treatment sequence.

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Melanoma: Dabrafenib and Trametinib in Treating Patients With Stage III-IV BRAF Mutant Melanoma That Cannot Be Removed by Surgery

Lead Researcher: Deepak Sahasrabudhe

This study will allow the researchers to know whether a break in treatment is better, the same, or worse than continuous treatment of dabrafenib and trametinib. To be better, the break in treatment approach should extend the time before cancer gets worse by about 4 to 6 months compared to the continuous treatment approach.

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Melanoma: Ipilimumab With or Without Nivolumab in Treating Patients With Melanoma That Is Stage IV or Stage III and Cannot Be Removed by Surgery

Lead Researcher: Deepak Sahasrabudhe

If you decide to participate in this research study, you will be randomly assigned to one of the treatment groups. This is done by chance, for every patient assigned to group 1 (ipilimumab alone) the computer will assign 3 patients to group 2 (ipilimumab and nivolumab). If you are assigned to group 1 (ipilimumab alone), you will receive the study drug for 12 weeks. If you are assigned to group 2 (ipilimumab and nivolumab) you will receive both ipilimumab and nivolumab for 12 weeks and then nivolumab alone for as long as your cancer does not get worse, the side effects are tolerable, and you agree to stay on study.

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MGD007 Combined With MGA012 in Relapsed/Refractory Metastatic Colorectal Cancer

Lead Researcher: Marcus Noel

This study is designed to characterize the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary anti-tumor activity of MGD007 and MGA012, administered in combination by IV infusion, in patients with relapsed/refractory metastatic colorectal carcinoma. The study consists of a Dose Escalation Phase to determine the Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) - MAD; if no MTD is defined - of the drug combination, followed by a Cohort Expansion Phase to further define the safety and initial anti-tumor activity of the drug combination with the doses established in the Dose Escalation Phase.

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Milrinone in Congenital Diaphragmatic Hernia

Infants with congenital diaphragmatic hernia (CDH) usually have pulmonary hypoplasia and persistent pulmonary hypertension of the newborn (PPHN) leading to hypoxemic respiratory failure (HRF). Pulmonary hypertension associated with CDH is frequently resistant to conventional pulmonary vasodilator therapy including inhaled nitric oxide (iNO). Increased pulmonary vascular resistance (PVR) can lead to right ventricular overload and dysfunction. In patients with CDH, left ventricular dysfunction, either caused by right ventricular overload or a relative underdevelopment of the left ventricle, is associated with poor prognosis. Milrinone is an intravenous inotrope and lusitrope (enhances cardiac systolic contraction and diastolic relaxation respectively) with pulmonary vasodilator properties and has been shown anecdotally to improve oxygenation in PPHN. Milrinone is commonly used during the management of CDH although no randomized trials have been performed to test its efficacy. Thirty percent of infants with CDH in the Children's Hospital Neonatal Database (CHND) and 22% of late-preterm and term infants with CDH in the Pediatrix database received milrinone. In the recently published VICI trial, 84% of patients with CDH received a vasoactive medication. In the current pilot trial, neonates with an antenatal or postnatal diagnosis of CDH will be randomized to receive milrinone or placebo to establish safety of this medication in CDH and test its efficacy in improving oxygenation.

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Moderately Preterm Infants With Caffeine at Home for Apnea (MoCHA) Trial

Apnea of prematurity (AOP) is a condition in which premature infants stop breathing for 15 to 20 seconds during sleep. The objective of this study is to evaluate the effect of continuing treatment with caffeine citrate in the hospital and at home in moderately preterm infants with resolved apnea of prematurity on days of hospitalization after randomization.

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MS PATHS Normative Sub-Study

Lead Researcher: Megan Hyland

The primary objective of this study is to determine the normative range of brain volume and brain volume change in healthy control (HC) participants whose age, race, and gender distribution is approximately matched to the age, race, and gender distribution of patients with Multiple Sclerosis (MS) enrolled in Study 888MS001. The secondary objective is to use the results of the primary endpoint to ensure consistency of brain volume measurements across MS PATHS centers.

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Multiple Cancers: A Study Exploring the Safety and Efficacy of INCAGN01949 in Combination With Immune Therapies in Advanced or Metastatic Malignancies

Lead Researcher: Marcus Noel

This study has 2 phases; depending on when you are enrolled into the study and what type of cancer you have, you will participate in 1 of the 2 phases. Phase 1 is the “Dose Escalation” portion of the Study. Certain dose levels of INCAGN01949, when given together with nivolumab and/or ipilimumab, will be evaluated in small groups of subjects (also called “cohorts”) with advanced or metastatic cervical cancer, uterine cancer, stomach cancer, throat cancer, liver cancer, specific types of skin cancer, a specific subtype of colon cancer, lung cancer, ovarian cancer, head and neck cancer, kidney cancer, a certain type of breast cancer, and bladder and urinary tract cancer. Subjects will be observed for a minimum of 28 days before the dose is increased for the next cohort. Phase 1 subjects will enroll into 1 of 3 different Study Drug Combination groups. Enrollment in this phase of the Study will continue until the highest dose of INCAGN01949 that is safe and tolerated by most subjects is found.Some subjects will be enrolled into safety expansion cohorts within Phase 1. These subjects will receive the same combinations and doses given in the dose escalation part of the study, however the administration of nivolumab and/or ipilimumab will begin after 2 cycles of INCAGN01949 are given. Phase 2 is the “Dose Expansion” portion of the Study. The dose of INCAGN01949 determined to be safe during the Phase 1 (Dose Escalation) portion of the Study will be given together with nivolumab and/or ipilimumab to subjects with kidney cancer or bladder and urinary tract cancer in 1 of 6 different Study Drug Combination groups. The dose of INCAGN01949 you receive in this Study will depend on the dose level being tested at the time you are enrolled. The doses of nivolumab and ipilimumab administered to you in this Study will not change.

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Multiple Cancers: Nivolumab and Ipilimumab in Treating Patients With Rare Tumors

Lead Researcher: Paul Barr

If you participate in this study you will receive the study drugs ipilimumab and nivolumab. You will receive both study drugs through a vein on the first day of each cycle (or every 6 weeks), and you will receive nivolumab through a vein every 2 weeks. You will continue to receive study drugs until your disease gets worse or you experience bad side effects from the study drugs or your study doctor decides that you are not benefiting from the study drugs.

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Multiple Cancers: Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)

Lead Researcher: Marcus Noel

If you decide to participate in this study, your tumor cells will be tested to find out if they have a gene change or mutation targeted by one or more of the drugs used in this study. If you have a gene change or mutation that matches a substudy, you will be asked if you want to participate in a specific substudy.

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Multiple Myeloma

Lead Researcher: Brea Lipe

The purpose of this study is to collect clinical data along with bone marrow aspirate samples to see if there is a way to determine which patients are more or less likely to experience disease progression. This study will involve identifying different markers on the surfaces of the plasma cells and will look at protein expression. We will then correlate those findings with data from your medical records over time. If you decide to take part in this study, you will be asked to allow additional bone marrow aspirate and blood samples to be collected for research at several time points. These additional samples will be collected during routine testing time points as required for your routine care. We will also collect information about your disease and treatment from your medical record.

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Multiple Myeloma or Lymphoma: Study of CLR 131 in Relapsed or Refractory Select B-Cell Malignancies

Lead Researcher: Brea Lipe

This research is being done to help us determine if the study drug is safe and can be tolerated for the treatment of multiple myeloma or certain lymphomas.

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Multiple Myeloma: A Study of Denosumab in Multiple Myeloma Patients With Renal Insufficiency

Lead Researcher: Brea Lipe

If you decide to participate in this study you will receive denosumab every 4 weeks for a total of 12 cycles.

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Multiple Myeloma: Integrating Touchscreen-based Geriatric Assessment and Frailty Screening for Adults with Multiple Myeloma to Drive Personalized Treatment Decisions

Lead Researcher: Supriya Mohile

If you enter the study, you will be asked to complete an electronic questionnaire on a sponsor- provided electronic tablet during an already scheduled clinical visit to your medical oncology doctor’s office. The questionnaire will take about 10 minutes to complete; study staff will remain available to assist you.

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Multiple Myeloma: Selinexor and Backbone Treatments of Multiple Myeloma Patients (STOMP)

Lead Researcher: Brea Lipe

This is an open-label study, which means that both you and your study doctor will know how much selinexor and the names of other medications you are taking. You, and all other patients in this study, will take the study drug selinexor, plus dexamethasone and either pomalidomide, bortezomib, lenalidomide, or daratumumab. The treatment period consists of blocks of time called cycles. The number of treatment cycles you receive will depend on how well you are doing on the treatment and how well your cancer responds to it. This study includes four different treatment combinations: • Selinexor, dexamethasone and pomalidomide (abbreviated as SPd) • Selinexor, dexamethasone and bortezomib (abbreviated as SVd) • Selinexor, dexamethasone and lenalidomide (abbreviated as SRd) • Selinexor, dexamethasone, daratumumab (abbreviated SDd)

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Muscle-Invasive Bladder Cancer: Durvalumab in combination with Gemcitabine and Cisplatin (Given Before the Primary Treatment) and Durvalumab Alone (Given After the Primary Treatment)

Lead Researcher: Chunkit Fung

A Global Study to Determine the Efficacy and Safety of Durvalumab in Combination with Gemcitabine+Cisplatin for Neoadjuvant Treatment (given before the primary treatment) and Durvalumab Alone for Adjuvant Treatment (given after the primary treatment) in Patients with Muscle-Invasive Bladder Cancer

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Myelodysplastic Syndromes: A Safety and Efficacy Study of Pracinostat and Azacitidine in Patients With High Risk Myelodysplastic Syndromes

Lead Researcher: Jason Mendler

In this research study, you will take either pracinostat or placebo 3 times a week for 3 weeks in a row followed by 1 week of rest. All subjects will receive azacitidine.

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Myocardial Ischemia and Transfusion

The purpose of this study is to compare two red blood cell transfusion strategies (liberal and restrictive) for patients who have had an acute myocardial infarction and are anemic.

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Myotonic Dystrophy and Facioscapulohumeral Muscular Dystrophy Registry

Lead Researcher: Al-rabi Tawil

Myotonic dystrophy (DM) and facioscapulohumeral muscular dystrophy (FSHD) are inherited disorders characterized by progressive muscle weakness and loss of muscle tissue. The purpose of this registry is to connect people with DM or FSHD with researchers studying these diseases. The registry will offer individuals with DM and FSHD an opportunity to participate in research that focuses of their diseases. The registry will also help scientists to accomplish research on DM and FSHD and to distribute their findings to patients and care providers.

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Nab-Paclitaxel in Treating Patients With Newly Diagnosed Bile Tract Cancer

Lead Researcher: Aram Hezel

This phase III trial studies how well gemcitabine hydrochloride and cisplatin - given with or without nab-paclitaxel - work in treating patients with newly diagnosed biliary tract cancers that have spread to other places in the body. Drugs used in chemotherapy, such as gemcitabine hydrochloride, cisplatin, and nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not known if giving gemcitabine hydrochloride and cisplatin with or without nab-paclitaxel may work better at treating biliary tract cancers.

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Neoadjuvant FOLFOX therapy and active surveillance without use of radiation in locally advanced rectal cancer

Lead Researcher: Marcus Noel

The purpose of this study is to evaluate the treatment of patients with locally advanced rectal cancer for complete response to neoadjuvant chemotherapy without the use of radiation and surgery. These patients will be evaluated for complete clinical response (cCR) after completing up to 10 cycles of modified FOLFOX (mFOLFOX) (fluorouracil, leucovorin, oxaliplatin) chemotherapy, with interval analysis after six cycles. Patients who have stable or progressive disease will be removed from study and treated per discretion of the treating physician. Those determined to have partial or complete response will complete full neoadjuvant treatment and undergo close surveillance with watchful waiting for local recurrence without immediate surgery. The primary endpoint of this study will be the rate of cCR, which is to include complete and near complete clinical response, with secondary endpoints of disease-free survival (DFS), overall survival (OS), quality of life (QOL), as well as evaluation of safety and toxicity.

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Neuropsychological and Behavioral Testing in Younger Patients With Cancer

Lead Researcher: Angela Girvin

This research trial studies neuropsychological (learning, remembering or thinking) and behavioral testing in younger patients with cancer. Collecting information over time from a series of tests may help doctors develop effective tests to measure neuropsychological and behavioral function of patients with cancer.

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Nivolumab After Surgery and Chemotherapy in Treating Patients With Stage IB-IIIA Non-small Cell Lung Cancer (An ALCHEMIST Treatment Trial)

This phase III ALCHEMIST trial studies how well nivolumab after surgery and chemotherapy work in treating patients with stage IB-IIIA non-small cell lung cancer. Monoclonal antibodies, such as nivolumab, may stimulate the immune system in different ways and kill tumor cells remaining after surgery and standard of care chemotherapy.

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Observation or Radiation Therapy in Treating Patients With Newly Diagnosed Grade II Meningioma That Has Been Completely Removed by Surgery

This randomized phase III trial studies how well radiation therapy works compared with observation in treating patients with newly diagnosed grade II meningioma that has been completely removed by surgery. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors.

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Observational Study of ICU Patients with Systemic Inflammatory Response Syndrome (SIRS)

Lead Researcher: Anthony Pietropaoli

An observational research study of subjects admitted to the ICU with severe SIRS (and/or sepsis). The study involves blood and urine testing, and research measurements of blood flow using ultrasound on enrolled subjects in the ICU. Healthy subjects will also be recruited as needed for collection of healthy blood samples for comparison studies.

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Olaparib and Cediranib Maleate in Treating Patients With Recurrent, Refractory, or Metastatic Endometrial Cancer

Lead Researcher: Richard Moore

This phase II trial studies how well olaparib and cediranib maleate work in treating patients with endometrial cancer that has come back (recurrent), does not respond to treatment (refractory), or has spread to other places in the body (metastatic). Olaparib and cediranib maleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

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Oropharyngeal Cancer Treatment: Reduced Dose Radiation Therapy with Chemotherapy (Cisplatin) or Immunotherapy (Nivolumab)

Lead Researcher: Ronald Maggiore

This phase II/III trial studies how well a reduced dose of radiation therapy works with nivolumab compared to cisplatin in treating patients with human papillomavirus (HPV)-positive oropharyngeal cancer that is early in its growth and may not have spread to other parts of the body (early-stage), and is not associated with smoking. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This trial is being done to see if a reduced dose of radiation therapy and nivolumab works as well as standard dose radiation therapy and cisplatin in treating patients with oropharyngeal cancer.

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Outcome Disparities in Adolescents with Acute Lymphoclastic Leukemia (ALL)

Lead Researcher: Kristen O'Dwyer

We will establish two prospective groups of patients with Acute Lymphoclastic Leukemia (ALL): "Cohort A" will be enrolled on the study at the time of diagnosis while "Cohort B" will be enrolled during maintenance chemotherapy.

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Ovarian Cancer: Efficacy and Safety Study of Cediranib in Combination With Olaparib in Patients With Recurrent Platinum-Resistant Ovarian Cancer (CONCERTO)

Lead Researcher: Richard Moore

The purpose of the study is to see if the combination of two drugs, cediranib and olaparib, is effective and tolerable in patients with ovarian cancer who have received at least 3 prior chemotherapy treatments, including treatment that included either carboplatin or cisplatin, and their disease came back within 6 months of the last dose of chemotherapy that included either cisplatin or carboplatin.

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Ovarian Cancer: Evaluation of a blood test that could help determine if a pelvic mass is cancerous or non-cancerous

Lead Researcher: Richard Moore

The purpose of this study is to validate and refine a technology that can help physicians determine whether an abnormal pelvic mass in women is benign (non-cancerous) or malignant (cancerous) using a blood test. The specific technology is called ParsortixTM PC1 system, a semi-automated system capable of capturing and harvesting rare cells for subsequent analysis from blood based on the size and deformability (i.e.compressibility) of the cells.

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Ovarian Cancer: Pegylated Liposomal Doxorubicin Hydrochloride With Atezolizumab and/or Bevacizumab in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Lead Researcher: Richard Moore

This study has 3 study groups, a computer will assign you to a study group by chance. There is an equal chance of receiving each treatment. This is done by chance, because no one knows if one study group is better or worse than the others. Group 1 will get an experimental chemotherapy treatment (liposomal doxorubicin and atezolizumab), group 2 will get an experimental chemotherapy treatment (liposomal doxorubicin and bevacizumab plus atezolizumab), and group 3 will get a usual chemotherapy treatment for this type of cancer (liposomal doxorubicin and bevacizumab). The liposomal doxorubicin will be given into your vein over approximately 60 minutes. The bevacizumab will be given into your vein over approximately 90 minutes initially, then faster at later visits if administration goes smoothly at the slower rates. The atezolizumab will be given into your vein over approximately 60 minutes initially, then faster at later visits if administration goes smoothly at the slower rates. Treatment will be given on days 1 and 15 of each 28-day period. This period of time is called a cycle, which is a regular schedule of treatment with periods of rest in between.

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Ovarian Cancer: Phase 2, A Study of Niraparib Combined With Bevacizumab Maintenance Treatment in Patients With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy

Lead Researcher: Richard Moore

It is not known how long your participation the study will last. You may receive Niraparib for up to 3 years and Bevacizumab for up to 15 months. The number of months that you receive bevacizumab on the study depends on how many months of bevacizumab you received with chemotherapy before this study.

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Ovarian Cancer: Tesaro-FIRST

Lead Researcher: Richard Moore

The purpose of this study is to compare the progression-free survival of patients with Stage III or IV non-mucinous epithelial ovarian cancer treated with platinum-based therapy, TSR-042, and niraparib to standard-of-care (SOC) platinum-based therapy.

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Ovarian Cancer: Use of the CA 125 Algorithm for the Early Detection of Ovarian Cancer in Low Risk Women

Lead Researcher: Richard Moore

You will have blood drawn for the CA-125 testing and other tumor markers, depending on your CA-125 level, you will return and have blood drawn in 1 year or in 3 months or in 6 weeks plus a transvaginal ultrasound.

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Ovarian Cancer: Utilizing Human Ovarian, Fallopian and Primary Peritoneal Cancer Patient Tissue to Identify Novel Therapies

Lead Researcher: Richard Moore

If you decide to take part in this study, you will be asked to donate tissue and ascites (left over after the surgery), blood and clinical data. Our study team member will first review your medical records to obtain information on your health status and history. Then, when you go in for surgery, on the day of surgery less than 4 tablespoons of blood and tissue samples and ascites fluid will be collected. You will be followed for information about your health status and treatment for up to 10 years after your surgery.

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Paclitaxel, Trastuzumab, and Pertuzumab With or Without Atezolizumab in Treating Patients With Metastatic Breast Cancer

Lead Researcher: Ajay Dhakal

This randomized phase III trial studies how well paclitaxel, trastuzumab, and pertuzumab with or without atezolizumab works in treating patients with breast cancer that has spread to other parts of the body. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with trastuzumab, pertuzumab, and atezolizumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving paclitaxel, trastuzumab, and pertuzumab with or without atezolizumab may kill more tumor cells.

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Palbociclib in Treating Patients With Relapsed or Refractory Rb Positive Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With Activating Alterations in Cell Cycle Genes (A Pediatric MATCH Treatment Trial)

Lead Researcher: Angela Girvin

This phase II Pediatric MATCH trial studies how well palbociclib works in treating patients with Rb positive solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with activating alterations (mutations) in cell cycle genes that have spread to other places in the body and have come back or do not respond to treatment. Palbociclib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

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Pancreatic Cancer: PEGylated Recombinant Human Hyaluronidase in Combo With Nab-Paclitaxel + Gemcitabine VS. Placebo + Nab-Paclitaxel and Gemcitabine in Participants With Hyaluronan-High Stage IV Previously Untreated Pancreatic Ductal Adenocarcinoma

Lead Researcher: Marcus Noel

PEGPH20 is an enzyme that breaks down a specific tissue component called hyaluronan (HA) produced by some tumors. Currently PEGPH20 is experimental and is being tested in patients with pancreatic and lung cancers.

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Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

Lead Researcher: Mohamedtaki Tejani

The purpose of this study is to evaluate the efficacy of pembrolizumab (MK-3745) in combination with chemotherapy (Cisplatin combined with 5-Fluorouracil [FP regimen] or oxaliplatin combined with capecitabine [CAPOX regimen]) versus placebo in combination with chemotherapy (FP or CAPOX regimens) in the treatment of human epidermal growth factor receptor 2 (HER2) negative advanced gastric or GEJ adenocarcinoma in adult participants. The primary hypotheses of this study are that pembrolizumab plus chemotherapy is superior to placebo plus chemotherapy in terms of overall survival (OS), and progression-free survival (PFS).

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Pembrolizumab and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma

Lead Researcher: Carla Casulo

The purpose of this research study is to evaluate a new drug Pembrolizumab in combination with chemotherapy, for Relapsed/Refractory Hodgkin Lymphoma. The chemotherapy regimen is called "ICE" and includes three drugs: ifosfamide, carboplatin, and etoposide. Pembrolizumab is currently Food and Drug Administration (FDA) approved for the treatment of some patients with melanoma, lung cancer and head and neck cancer, but has not yet been approved for the treatment of Relapsed/Refractory Hodgkin Lymphoma. The 'ICE' regimen of chemotherapy is currently FDA approved for the treatment of Relapsed/Refractory Hodgkin Lymphoma, but has not yet been investigated in combination with pembrolizumab for this disease. For patients who have a relapse of their Hodgkin's lymphoma, retreatment with chemotherapy followed by a stem cell transplant is recommended. We know that obtaining a complete remission (not able to detect any disease on scans) is very important prior to proceeding to the stem cell transplant. Patients with negative scans have a lower chance of the disease coming back and a higher chance of achieving a long-term cure.

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Pevonedistat and Azacitidine in MDS or MDS/MPN Patients

Lead Researcher: Jason Mendler

The purpose of this study is to compare survival of patients treated with a combination of pevonedistat and azacitidine after failure of DNA methyltransferase inhibitors to historical survival for patients with relapsed/refractory myelodysplastic syndrome or myelodysplastic/ myeloproliferative overlap syndromes who are ineligible for hematopoietic stem cell transplant.

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Phase 3 Alogliptin Pediatric Study

This study will evaluate the efficacy and safety of alogliptin 25 mg once daily (QD) compared to placebo when administered as monotherapy, or when added onto a background of metformin alone, insulin alone, or a combination of metformin and insulin in pediatric participants 10 to 17 years of age with type 2 diabetes mellitus (T2DM).

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Phase 4 Study of Obeticholic Acid Evaluating Clinical Outcomes in Patients With Primary Biliary Cholangitis

Primary Biliary Cholangitis (PBC) formerly known as primary biliary cirrhosis is a serious, life-threatening, bile acid related liver disease of unknown cause. Without treatment, it frequently progresses to liver fibrosis and eventual cirrhosis requiring liver transplantation or resulting in death. The investigational drug, Obeticholic Acid (OCA) helps prevent liver damage and improves liver function. The study will assess the effect of OCA compared to placebo, combined with stable standard care, on clinical outcomes in PBC patients.

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Phase I/II NabPaclitaxel, Paclitaxel&Carboplatin w RTX Followed by Consolidation in Patients w Favorable Prognosis Inoperable Stage IIIA/B NSCLC

Lead Researcher: Yuhchyau Chen

The investigators propose this phase I/II study to use weekly Nab-Paclitaxel (Abraxane) and carboplatin with concurrent radiation in local-regionally advanced lung cancer. There are no published human studies combining Nab-Paclitaxel (Abraxane) with radiation. The investigators will first confirm the tolerated dose (TD) of concurrent Nab-Paclitaxel (Abraxane) at 50mg/m2, and then will begin enrolling patients into the phase II component using either Nab-Paclitaxel (Abraxane) at the TD with carboplatin concurrent with daily radiation or paclitaxel with with carboplatin concurrent with daily radiation.

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PI3K/mTOR Inhibitor LY3023414 in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With TSC or PI3K/MTOR Mutations (A Pediatric MATCH Treatment Trial)

This phase II Pediatric MATCH trial studies how well PI3K/mTOR inhibitor LY3023414 works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with TSC or PI3K/MTOR mutations that have spread to other places in the body and have come back or do not respond to treatment. PI3K/mTOR inhibitor LY3023414 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

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PKUDOS: Phenylketonuria (PKU) Demographic, Outcomes, and Safety Registry

The objective of this study is to evaluate the safety of long-term treatment with Kuvan.

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Preemie Hypothermia for Neonatal Encephalopathy

Lead Researcher: Carl D'Angio

Encephalopathy is a general term that means brain disease, damage, or malfunction. This study is a randomized, controlled trial to assess safety and effectiveness of whole body hypothermia for 72 hours in preterm infants 33-35 weeks gestational age (GA) who present at <6 hours postnatal age with moderate to severe neonatal encephalopathy (NE). The study will enroll infants with signs of NE at 18 NICHD Neonatal Research Network sites, and randomly assign them to either receive hypothermia or participate in a non-cooled control group.

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Pregnancy Outcome and Safety of Interrupting Therapy for Women With Endocrine Responsive Breast Cancer (POSITIVE)

Lead Researcher: Alissa Huston

The best available evidence suggests that pregnancy after breast cancer does not increase a woman's risk of developing a recurrence from her breast cancer. In particular, the most recent data suggest that this is the case also in women with a hormone receptor-positive breast cancer. There is also no indication of increased risk for delivery complications or for the newborn. The aim of the study is to investigate if temporary interruption of endocrine therapy, with the goal to permit pregnancy, is associated with a higher risk of breast cancer recurrence.The study aims also to evaluate different specific indicators related to fertility, pregnancy and breast cancer biology in young women. A psycho-oncological companion study on fertility concerns, psychological well-being and decisional conflicts will be conducted in interested Centers.

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Project: Every Child for Younger Patients With Cancer

Lead Researcher: Angela Girvin

This research trial studies the Project: Every Child for younger patients with cancer. Gathering health information over time from younger patients with cancer may help doctors find better methods of treatment and on-going care.

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Prostate cancer: A laboratory study to isolate and manipulate circulating tumor cells in prostate cancer.

Lead Researcher: Deepak Sahasrabudhe

If you decide to participate in this study, your blood will be drawn periodically before, during and after therapy. You will be asked to provide ¬¬¬¬1.5 teaspoons of blood at a time. Blood samples will be collected before start of treatment and then approximately every one to three weeks for up to 12 months.

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Prostate Cancer: A Study of Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency (TRITON2)

Lead Researcher: Chunkit Fung

This research study is divided into three phases: Screening Phase is performed to find out if you are eligible for the study. If you qualify, you will be enrolled into the study and begin treatment. Treatment Phase (continuous dosing with rucaparib) Follow-up Phase: Follow Up visit (28 days after your last dose of rucaparib) and long term follow-up approximately every 12 weeks

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Prostate Cancer: A Study of Rucaparib Verses Physician's Choice of Therapy in Patients With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency (TRITON3)

Lead Researcher: Chunkit Fung

If you participate in this study, you will be assigned at random to receive treatment with either an experimental drug (called rucaparib) or one of the following comparator treatments: abiraterone acetate, enzalutamide, or docetaxel. If you are assigned to receive comparator treatment, your study doctor will help determine which one of the three therapy options is most appropriate for you. Approximately two thirds of the patients will be assigned to receive treatment with rucaparib and one-third will be assigned to receive comparator treatment.

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Prostate Cancer: Cisplatin in Prostate Cancer

Lead Researcher: Deepak Sahasrabudhe

If you choose to participate in this study, you will receive cisplatin once per week for 6 weeks and you will continue to receive leuprolide and enzalutamide. You will also have blood samples collected at enrollment, 3 weeks, 5 weeks, and conclusion of treatment for research purposes.

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QUILT-3.055: A Study of ALT-803 in Combination With PD-1/PD-L1 Checkpoint Inhibitor in Patients With Advanced Cancer

Lead Researcher: Deborah Mulford

This is a Phase IIb, single-arm, multicohort, open-label multicenter study of ALT-803 in combination with an FDA-approved PD-1/PD-L1 checkpoint inhibitor in patients with advanced cancers who have progressed following an initial response to treatment with PD-1/PD-L1 checkpoint inhibitor therapy. All patients will receive the combination treatment of PD-1/PD-L1 checkpoint inhibitor plus ALT-803 for up to 16 cycles. Each cycle is six weeks in duration. All patients will receive ALT-803 once every 3 weeks. Patients will also receive the same checkpoint inhibitor that they received during their previous therapy. Radiologic evaluation will occur at the end of each treatment cycle. Treatment will continue for up to 2 years, or until the patient experiences confirmed progressive disease or unacceptable toxicity, withdraws consent, or if the Investigator feels it is no longer in the patient's best interest to continue treatment. Patients will be followed for disease progression, post-therapies, and survival through 24 months past administration of the first dose of study drug.

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Radiation Therapy and Cisplatin With or Without Triapine in Treating Patients With Newly Diagnosed Stage IB2, II, or IIIB-IVA Cervical Cancer or Stage II-IVA Vaginal Cancer

Lead Researcher: Richard Moore

This randomized phase III trial studies radiation therapy and cisplatin with triapine to see how well they work compared to the standard radiation therapy and cisplatin alone in treating patients with newly diagnosed stage IB2, II, or IIIB-IVA cervical cancer or stage II-IVA vaginal cancer. Radiation therapy uses high energy protons to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Triapine may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether radiation therapy and cisplatin are more effective with triapine in treating cervical or vaginal cancer.

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Radiation Therapy Regimens in Treating Patients With Limited-Stage Small Cell Lung Cancer Receiving Cisplatin and Etoposide

Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as etoposide, carboplatin and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known which radiation therapy regimen is more effective when given together with chemotherapy in treating patients with limited-stage small cell lung cancer. This randomized phase III trial is comparing different chest radiation therapy regimens to see how well they work in treating patients with limited-stage small cell lung cancer.

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Radiation Therapy With Durvalumab or Cetuximab in Treating Patients With Head and Neck Cancer

Lead Researcher: Yuhchyau Chen

This randomized phase II/III trial studies how well radiation therapy works with durvalumab or cetuximab in treating patients with head and neck cancer that has spread to a local and/or regional area of the body who cannot take cisplatin. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Immunotherapy with monoclonal antibodies, such as durvalumab or cetuximab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is not known if radiation therapy with durvalumab will work better than the usual therapy of radiation therapy with cetuximab in treating patients with head and neck cancer.

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Ramucirumab and Pembrolizumab Versus Standard of Care in Treating Patients With Stage IV or Recurrent Non-small Cell Lung Cancer (A Lung-MAP Non-Match Treatment Trial)

Lead Researcher: Megan Baumgart

This phase II Lung-MAP non-Match treatment trial studies how well ramucirumab and pembrolizumab work versus standard of care in treating patients with non-small cell lung cancer that is stage IV or has come back. Immunotherapy with monoclonal antibodies, such as ramucirumab and pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in standard of care chemotherapy for non-small cell lung cancer, such as docetaxel, gemcitabine hydrochloride, and pemetrexed, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ramucirumab and pembrolizumab together may work better in treating patients with non-small lung cancer compared to standard of care.

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Rectal Cancer: Phase II/III study of FOLFOX chemotherapy with or without radiation treatment before surgery for locally advanced rectal cancer. (N1048)

Lead Researcher: Aram Hezel

The standard treatment for locally advanced rectal cancer involves chemotherapy and radiation, known as 5FUCMT, (the chemotherapy drugs, 5-fluorouracil/capecitabine and radiation therapy) prior to surgery. This results in high rates of disease control with significant side effects. The purpose of this study is to compare the effects of the standard treatment of chemotherapy and radiation to chemotherapy alone. The aim of this study is to determine if we can reduce the side effects while still controlling the disease. The chemotherapy alone is the combination regimen known as FOLFOX, (the drugs 5-fluorouracil (5-FU), oxaliplatin and leucovorin). Depending on the response to FOLFOX you may also receive the standard treatment 5FUCMT. The drugs used in this study are all FDA (Food and Drug Administration) approved for the treatment of colorectal cancer. The use of FOLFOX chemotherapy alone in place of 5FUCMT is experimental. In case FOLFOX chemotherapy alone does not work, you will receive standard treatment which is 5FUCMT followed by surgery.

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Reduced Craniospinal Radiation Therapy and Chemotherapy in Treating Younger Patients With Newly Diagnosed WNT-Driven Medulloblastoma

Lead Researcher: Angela Girvin

This phase II trial studies how well reduced doses of radiation therapy to the brain and spine (craniospinal) and chemotherapy work in treating patients with newly diagnosed type of brain tumor called WNT/Wingless (WNT)-driven medulloblastoma. Recent studies using chemotherapy and radiation therapy have been shown to be effective in treating patients with WNT-driven medulloblastoma. However, there is a concern about the late side effects of treatment, such as learning difficulties, lower amounts of hormones, or other problems in performing daily activities. Radiotherapy uses high-energy radiation from x-rays to kill cancer cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, vincristine sulfate, cyclophosphamide and lomustine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving reduced craniospinal radiation therapy and chemotherapy may kill tumor cells and may also reduce the late side effects of treatment.

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Registry of Full-genome Data Linked with Clinical Data to Evaluate New Gene Associations in Breast Cancer

Lead Researcher: Ajay Dhakal

The purpose of this registry is to create a large-scale, population-based database. This database will match health information to genome data to identify new gene associations in breast cancer. The study will look at Agendia Breast Cancer tests, including MammaPrint® and BluePrint™, which are tests that help doctors analyze and profile breast cancer tumors.

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Related-Donor Bone Marrow Transplant at URMC

Lead Researcher: Jeffrey Andolina

This study will be a single-center treatment protocol with five possible preparative regimens, designed to validate the process of related donor haploidentical stem cell transplantation at the Wilmot Cancer Institute Blood and Marrow Transplant Unit. Enrolled patients will receive chemotherapy +/- radiation as a pre-transplant conditioning regimen. Patients will then receive haploidentical stem cells, either bone marrow or mobilized peripheral blood, followed by GvHD prophylaxis that will include cyclophosphamide. Multiple data points will be collected prior to, during, and following transplantation to ensure safety of the process and to evaluate the stated objectives.

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Response and Biology-Based Risk Factor-Guided Therapy in Treating Younger Patients With Non-high Risk Neuroblastoma

Lead Researcher: Angela Girvin

This phase III trial studies how well response and biology-based risk factor-guided therapy works in treating younger patients with non-high risk neuroblastoma. Sometimes a tumor may not need treatment until it progresses. In this case, observation may be sufficient. Measuring biomarkers in tumor cells may help plan when effective treatment is necessary and what the best treatment is. Response and biology-based risk factor-guided therapy may be effective in treating patients with non-high risk neuroblastoma and may help to avoid some of the risks and side effects related to standard treatment.

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Response-Based Chemotherapy in Treating Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome in Younger Patients With Down Syndrome

Lead Researcher: Angela Girvin

This phase III trial studies response-based chemotherapy in treating newly diagnosed acute myeloid leukemia or myelodysplastic syndrome in younger patients with Down syndrome. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Response-based chemotherapy separates patients into different risk groups and treats them according to how they respond to the first course of treatment (Induction I). Response-based treatment may be effective in treating acute myeloid leukemia or myelodysplastic syndrome in younger patients with Down syndrome while reducing the side effects.

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Rituximab in Treating Patients With Mantle Cell Lymphoma

Lead Researcher: Paul Barr

This randomized phase III trial studies rituximab after stem cell transplant and to see how well it works compared with rituximab alone in treating patients with in minimal residual disease-negative mantle cell lymphoma in first complete remission. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Giving chemotherapy before a stem cell transplant helps kill any cancer cells that are in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Giving rituximab with or without stem cell transplant may work better in treating patients with mantle cell lymphoma.

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Ruxolitinib Phosphate and Dasatinib or Nilotinib in Treating Patients With Chronic Myeloid Leukemia

Lead Researcher: Kristen O'Dwyer

This randomized phase II trial studies how well ruxolitinib phosphate and dasatinib or nilotinib work in treating patients with chronic myeloid leukemia. Ruxolitinib, dasatinib, and nilotinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

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Ruxolitinib Phosphate, Paclitaxel, and Carboplatin in Treating Patients With Stage III-IV Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Lead Researcher: Richard Moore

This phase I/II partially randomized trial studies the side effects and the best dose of ruxolitinib phosphate when given together with paclitaxel and carboplatin, and it will look at how well these drugs work in treating patients with stage III-IV epithelial ovarian, fallopian tube, or primary peritoneal cancer. Ruxolitinib phosphate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ruxolitinib phosphate together with paclitaxel and carboplatin may be a better treatment for epithelial ovarian, fallopian tube, or primary peritoneal cancer.

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Safety and Efficacy of Chlorthalidone in Type 1 Diabetes

Lead Researcher: David Weber

Chlorthalidone is a prescription drug used to treat high blood pressure (hypertension). This open-label study will determine if chlorthalidone is safe and effective for the use of reducing the amount of calcium in urine over 4 weeks in patients with type 1 diabetes.

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Safety and Efficacy of KTE-X19 in Adults With Relapsed/Refractory Chronic Lymphocytic Leukemia (ZUMA-8)

Lead Researcher: Patrick Reagan

Participants will receive conditioning chemotherapy (fludarabine and cyclophosphamide), followed by the investigational treatment, KTE-X19. KTE-X19 is a CAR-T Cell Therapy (infusion).

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Safety and Efficacy Study of Gantenerumab in Participants With Early Alzheimer's Disease (AD)

This randomized, double-blind, placebo-controlled, parallel group study will evaluate the efficacy and safety of gantenerumab versus placebo in participants with early (prodromal to mild) AD. All participants must show evidence of beta-amyloid pathology. Eligible participants will be randomized 1:1 to receive either subcutaneous (SC) injection of gantenerumab or placebo. The primary efficacy assessment will be performed at the end of the double blind period at week 104. Participants will then be offered to enter into an open-label extension (OLE). Participants not willing to go to the OLE will participate in a long term follow-up period for up to 50 weeks after the last gantenerumab dose.

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Safety and Efficacy Study of Oral Fosfomycin Versus Oral Levofloxacin to Treat Complicated Urinary Syndromes (FOCUS)

This is a Phase 4, multi-center, open-label, randomized pragmatic superiority clinical trial comparing two strategies for initial or step-down oral therapy for complicated urinary tract infections (cUTI) after 0-48 hours of parenteral antibiotic therapy. The trial will evaluate the success and safety of a strategy of initial or step-down fosfomycin, administered at a dose of 3 g once daily, vs. a strategy of initial or step-down levofloxacin administered at a dose of 750 mg once daily. Investigator-directed adjustment to another adequate oral therapy is allowed 1) if the causative pathogen is not susceptible in vitro to quinolone initial or step-down therapy in a subject randomized to the levofloxacin strategy, OR 2) if the subject develops a significant related AE (either grade 3 or at the investigator's discretion) to the initial or step-down oral therapy. The duration of oral therapy (initial + investigator-directed adjustment if indicated) in each strategy is 5-7 days of any per protocol antibiotic to which the pathogen is susceptible. The dosing of oral therapy depends on creatinine clearance (CrCl). The trial will enroll approximately 536 patients that are either male or female aged 18 or older with cUTI from outpatient and inpatient settings. The study will take place over 25 months in approximately 12 to 15 US sites. The primary objective is to compare Strategy 1 and Strategy 2 in terms of treatment success rates at Test of Cure (TOC).

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Safety and Tolerability of TAR-200 and Nivolumab in Subjects With Muscle-Invasive Bladder Cancer

The purpose of this study is to determine if TAR-200, an investigational drug delivery system, in combination with nivolumab, is safe and tolerable in patients with muscle-invasive bladder cancer (MIBC) who are scheduled for radical cystectomy (RC).

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Sarcoma: Sapanisertib or Pazopanib Hydrochloride in Treating Patients With Locally Advanced or Metastatic Sarcoma

Lead Researcher: Deepak Sahasrabudhe

You will receive the MLN0128 for as long as the drug is preventing your cancer from growing and the side effects are reasonable. After you finish taking MLN0128, your doctor will continue to watch you for side effects and follow your condition for at least 30 days. Your doctor will continue to watch you for up to 2 years after you begin treatment.

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Selumetinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With Activating MAPK Pathway Mutations (A Pediatric MATCH Treatment Trial)

Lead Researcher: Angela Girvin

This phase II Pediatric MATCH trial studies how well selumetinib works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with MAPK pathway activation mutations that have spread to other places in the body and have come back or do not respond to treatment. Selumetinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

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Serum Tumor Marker Directed Disease Monitoring in Patients With Hormone Receptor Positive Her2 Negative Metastatic Breast Cancer

Lead Researcher: Alissa Huston

This randomized research trial studies how well serum tumor marker directed disease monitoring works in monitoring patients with hormone receptor positive Her2 negative breast cancer that has spread to other places in the body. Using markers to prompt when scans should be ordered may be as good as the usual approach to monitoring disease.

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Skin Cancer: Safety and Efficacy of Pembrolizumab (trade name Keytruda) Compared to Placebo

Lead Researcher: Deepak Sahasrabudhe

Pembrolizumab is an antibody that blocks a protective mechanism of cancer cells and thereby allows the immune system to destroy them. This study will evaluate pembrolizumab compared to placebo in participants after the surgical removal of stage II melanoma. Participants in Part 1 will receive either pembrolizumab or placebo in a double-blind design for up to 17 cycles. Part 2 is an open-label design for participants who receive placebo in Part 1 or who stop treatment after receiving 17 cycles of pembrolizumab in Part 1. They may be eligible to receive up to 35 additional cycles of pembrolizumab in Part 2.

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Skin Cancer: Study of REGN2810 in Patients With Advanced Cutaneous Squamous Cell Carcinoma

Lead Researcher: Sherrif Ibrahim

REGN2810 is a type of drug called a monoclonal antibody. Antibodies are proteins that are naturally found in your blood stream that fight infections. A monoclonal antibody is a special kind of antibody that is created in a laboratory. It is a medication that binds to specific proteins in the body that may be involved in your cancer. This study is being done to test if REGN2810 can reduce the size of your tumor by helping the immune system destroy the tumor. The study is also being done to test the safety of REGN2810 in CSCC patients.

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Sorafenib Tosylate With or Without Stereotactic Body Radiation Therapy in Treating Patients With Liver Cancer

This randomized phase III trial studies sorafenib tosylate and stereotactic body radiation therapy to see how well they work compared to sorafenib tosylate alone in treating patients with liver cancer. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Stereotactic body radiation therapy may be able to send the radiation dose directly to the tumor and cause less damage to normal tissue. Giving sorafenib tosylate together with stereotactic body radiation therapy may kill more tumor cells.

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Squamous Cell Carcinoma of the Head and Neck Cancer: PD 0332991 and Cetuximab in Patients With Incurable SCCHN

Lead Researcher: Ronald Maggiore

If you participate in this study you will be taking palbociclib and cetuximab as treatment for your cancer. Palbociclib is taken by mouth once a day and cetuximab is given intravenously weekly.

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Standard of Care Therapy With or Without Stereotactic Radiosurgery and/or Surgery in Treating Patients With Limited Metastatic Breast Cancer

Lead Researcher: Yuhchyau Chen

Stereotactic radiosurgery (SRS) is a non-surgical radiation therapy used to treat functional abnormalities and small tumors of the brain. It can deliver precisely-targeted radiation in fewer high-dose treatments than traditional therapy, which can help preserve healthy tissue. This randomized phase II/III trial studies how well standard of care therapy with stereotactic radiosurgery and/or surgery works and compares it to standard of care therapy alone in treating patients with breast cancer that has spread to one or two locations in the body (limited metastatic) that are previously untreated. Standard of care therapy comprising chemotherapy, hormonal therapy, biological therapy, and others may help stop the spread of tumor cells. Radiation therapy and/or surgery is usually only given with standard of care therapy to relieve pain; however, in patients with limited metastatic breast cancer, stereotactic radiosurgery, also known as stereotactic body radiation therapy, may be able to send x-rays directly to the tumor and cause less damage to normal tissue and surgery may be able to effectively remove the metastatic tumor cells. It is not yet known whether standard of care therapy is more effective with stereotactic radiosurgery and/or surgery in treating limited metastatic breast cancer.

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Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer

Lead Researcher: Chunkit Fung

This phase III trial studies how well standard systemic therapy with or without definitive treatment (prostate removal surgery or radiation therapy) works in treating participants with prostate cancer that has spread to other places in the body. Addition of prostate removal surgery or radiation therapy to standard systemic therapy for prostate cancer may lower the chance of the cancer growing or spreading.

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Study Assessing Safety and Efficacy of Combination of BL-8040 and Pembrolizumab in Metastatic Pancreatic Cancer Patients (COMBAT/KEYNOTE-202)

Lead Researcher: Jessica Mackowiak

This study will assess the efficacy and safety of BL-8040 in combination with pembrolizumab (Keytruda®) and BL8040/Pembrolizumab in combination with liposomal irinotecan (Onivyde®)/5-fluorouracil/leucovorin (5-FU/LV) in subjects with metastatic pancreatic adenocarcinoma.

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Study Comparing Two Different Schedules of Radiation for Early-stage Lung Cancer

Lead Researcher: Deepinder Singh

This study's goal is to find out if the kind of side effects people experience from radiation is different depending on the schedule of their radiation treatment. Patients will be randomly assigned to either the 3 Fraction or 5 Fraction schedule of radiation. After patients complete radiation treatment, they will follow up with their radiation oncologist.

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Study of Arimoclomol in Inclusion Body Myositis (IBM)

Lead Researcher: Elizabeth Luebbe

Funding Source - FDA OOPD. The purpose of this study is to evaluate the safety and efficacy of the study drug, Arimoclomol in IBM patients.

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Study of BHV-4157 in Alzheimer's Disease

Preclinical models suggest that riluzole, the active metabolite of BHV-4157, may protect patients from AD-related pathology and cognitive dysfunction. Titrated dose of BHV-4157 to 280 mg, or placebo, taken orally once daily. Duration of treatment is 48 weeks. There is also a screening period of up to 42 days; and a 4-week post-treatment observation period.

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Study of Durvalumab Given With Chemotherapy, Durvalumab in Combination With Tremelimumab Given With Chemotherapy, or Chemotherapy in Patients With Unresectable Urothelial Cancer (NILE)

Lead Researcher: Chunkit Fung

This is a randomized, open-label, controlled, multi-center, global Phase III study to determine the efficacy and safety of combining durvalumab ± tremelimumab with standard of care (SoC) chemotherapy (cisplatin + gemcitabine or carboplatin + gemcitabine doublet) followed by durvalumab monotherapy versus SoC alone as first-line chemotherapy in patients with histologically or cytologically documented, unresectable, locally advanced or metastatic transitional cell carcinoma of the urothelium (including renal pelvis, ureters, urinary bladder, and urethra).

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Study of Immunotherapy + Radiation in Soft Tissue Cancer

Lead Researcher: Deepak Sahasrabudhe

The main aim of immunotherapy is to enable patients' immune system to target cancer cells and destroy them. This study will treat patients with soft tissue sarcoma (cancer) with neoadjuvant nivolumab and ipilimumab, antibodies that can be used as immunotherapies. Patients will also receive concurrent radiation therapy. Following these treatments will be the surgical removal of the patent's soft tissue sarcoma.

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Study of PTC299 in Relapsed/Refractory Acute Leukemias

Lead Researcher: Michael Becker

This is an open-label, non-randomized, Phase 1b study to evaluate the safety, pharmacokinetics (PK) profiles, and preliminary evidence of antitumor activity of PTC299 and the metabolite, O-desmethyl PTC299, in participants with relapsed/refractory acute myeloid leukemia (AML) who have exhausted standard available therapies known to provide clinical benefit. The study is designed as a series of cohort-based dose escalations. For each cohort, a minimum of 3 evaluable participants with PK and safety data will be assessed. Additional participants will be recruited if additional PK data are needed to assess mean exposure based on the observed variability.

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Study of SBP-101 Combined With Nab-Paclitaxel and Gemcitabine in Pancreatic Cancer

Lead Researcher: Aram Hezel

This is an open-label phase 1A/1B study to assess the safety, tolerability, and movement throughout the body (pharmacokinetics) of SBP-101 when combined with nab-paclitaxel and gemcitabine in patients with previously untreated pancreatic cancer (metastatic pancreatic ductal adenocarcinoma) and to identify a recommended phase 2 dose. The study will also assess preliminary efficacy of the 3-drug treatment combination.

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Study of Testosterone and rHGH in FSHD

Lead Researcher: Elizabeth Luebbe

The purpose of this study is to investigate the safety and tolerability of combination therapy with recombinant human growth hormone (rHGH) and testosterone in adult male patients with facioscapulohumeral muscular dystrophy (FSHD) over 24 weeks.

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Study of the drug acalabrutinib and rituximab in patients with CLL/SLL

Lead Researcher: Paul Barr

Despite an array of available therapies, chronic lymphocytic leukemia (CLL) remains an incurable disease. The development of an improved therapy would be a major contribution to the management of CLL and other B cell malignancies. The investigator proposes that the drug acalabrutinib will work better combined with high frequency low dose subcutaneous rituximab in the treatment of CLL.

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Study on Olaparib Plus Abiraterone as First-line Therapy in Men With Metastatic Castration-resistant Prostate Cancer

Lead Researcher: Chunkit Fung

The purpose of this study is to evaluate the efficacy and safety (including evaluating side effects) of combination of olaparib and abiraterone versus placebo and abiraterone in patients with metastatic castration-resistant prostate cancer (mCRPC) who have received no prior cytotoxic chemotherapy or new hormonal agents (NHAs) at metastatic castration-resistant prostate cancer (mCRPC) stage.

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Study to Compare Oral PF-06651600, PF-06700841 and Placebo in Subjects With Moderate to Severe Ulcerative Colitis

Ulcerative colitis is an inflammatory bowel disease (IBD) that causes long-lasting inflammation and ulcers (sores) in your digestive tract. Ulcerative colitis affects the innermost lining of your large intestine (colon) and rectum. The purpose of this study is to determine whether PF-06651600 and PF-06700841 are effective in treatment of moderate to severe ulcerative colitis.

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Study to Investigate Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years and Over With Moderate to Severe Atopic Dermatitis With the Option of Rescue Treatment in Flaring Subjects

Lead Researcher: Lisa Beck

B7451014 is a Phase 3 study to investigate PF-04965842 in patients aged 12 years and over with a minimum body weight of 40 kg who have moderate to severe atopic dermatitis. Subjects responding well to an initial open-label 12 week treatment of PF-04965842 (200 mg) taken orally once daily (QD) will be identified and randomized in a double-blind manner to receive 200 mg QD PF-04965842, 100 mg QD PF-04965842, or QD placebo. Efficacy and safety of 2 doses of PF-04965842 will be evaluated relative to placebo over 40 weeks. Subjects experiencing significant worsening of their symptoms, i.e., protocol-defined flare, enter 12 weeks rescue treatment and receive 200 mg PF-04965842 together with a marketed topical medicine. Eligible patients will have the option to enter a long-term extension study after completing the initial 12 week treatment, the 12 week rescue treatment, and the 40 week blinded treatment.

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Studying Infant Nutrition and Blood Sugar in Breastfed Infants

Lead Researcher: Bridget Young

This study is for pregnant women who plan on breastfeeding their baby for at least 5 months. You and your baby will have two study visits over the first 6 months of your baby's life at the University of Rochester Medical Center. We will ask for some blood and some breast milk from you. We will ask for some urine and stool, and a heel prick from your baby.

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SUPER-PD: Sensor Use to Monitor Progression and Evaluate Symptoms Remotely in Parkinson’s Disease

Lead Researcher: Earl Dorsey

This study will test and compare multiple technologies, including a smartphone application, wearable sensors, a home monitoring device, and a video tool. Participants will complete 5 in-person visits over the course of about 2 years. They will also choose at least one remote technology to use and perform some activities at home.

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Targeted Lung Cancer Treatment Study (Lung-MAP Study)

Lead Researcher: Megan Baumgart

This study is being done to answer the following question: Can we lower the chance of your lung cancer growing or spreading by using a drug that targets a biomarker (biological marker) present in your tumor? We are doing this study because we want to find out if this approach is better or worse than the usual approach for your lung cancer. The usual approach is defined as care most people get for their lung cancer.

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Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial)

Lead Researcher: Angela Girvin

This Pediatric MATCH screening and multi-sub-study phase II trial studies how well treatment that is directed by genetic testing works in pediatric patients with solid tumors, non-Hodgkin lymphomas, or histiocytic disorders that have progressed following at least one line of standard systemic therapy and/or for which no standard treatment exists that has been shown to prolong survival. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic changes or abnormalities (mutations) may benefit more from treatment which targets their tumor's particular genetic mutation, and may help doctors plan better treatment for patients with solid tumors or non-Hodgkin lymphomas.

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Tazemetostat in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Endometrial Cancer

Lead Researcher: Richard Moore

This phase II trial studies how well tazemetostat works in treating patients with ovarian, primary peritoneal, or endometrial cancer that has come back. Drugs used in chemotherapy, such as tazemetostat, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

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Testing Maintenance Immunotherapy in Patients With Oropharynx Cancer

Lead Researcher: Ronald Maggiore

This phase II/III trial studies whether maintenance immunotherapy (nivolumab) following definitive treatment with radiation and chemotherapy (cisplatin) result in significant improvement in overall survival (time being alive) and progression-free survival (time being alive without cancer) for patients with intermediate risk human papillomavirus (HPV) positive oropharynx cancer that has spread to nearby tissue or lymph nodes. Drugs used in chemotherapy such as cisplatin work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether chemotherapy and radiation therapy followed by maintenance nivolumab therapy works better than chemotherapy and radiation therapy alone in treating patients with HPV positive oropharyngeal cancer.

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Testing the Addition of a New Anti-cancer Drug, Venetoclax, to Usual Chemotherapy for High Grade B-cell Lymphomas

Lead Researcher: Patrick Reagan

This phase II/III trial tests whether it is possible to decrease the chance of high-grade B-cell lymphomas returning or getting worse by adding a new drug, venetoclax to the usual combination of drugs used for treatment. Venetoclax may stop the growth of cancer cells by blocking a protein called Bcl-2. Drugs used in usual chemotherapy, such as rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone, and etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving venetoclax together with usual chemotherapy may work better than usual chemotherapy alone in treating patients with high-grade B-cell lymphomas, and may increase the chance of cancer going into remission and not returning.

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Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors

Lead Researcher: Adrienne Victor

This phase II trial studies how well cabozantinib works in combination with nivolumab and ipilimumab in treating patients with rare genitourinary (GU) tumors that have spread to other places in the body. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cabozantinib, nivolumab, and ipilimumab may work better in treating patients with genitourinary tumors that have no treatment options compared to giving cabozantinib, nivolumab, or ipilimumab alone.

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The LGBTQI parental experience with newborn nutrition

Lead Researcher: Rita Dadiz

Eligible participants include parents of a newborn child born within the past 1 year from time of recruitment. Parents must have identified as LGBTQI during the birthing and initial newborn hospitalization period. Adopted parents are eligible if they were involved in the birthing process. Parents must be at least 18 years old. The study includes two brief surveys which can be done online or on paper and a 60-90 minute interview done either in person or through video conferencing.

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The REPLACE Registry-for people who take Cholbam/Kolbam (Cholic Acid)

Lead Researcher: Nanda Kerkar

This is a study for people who take Cholbam/Kolbam also known as Cholic acid. You will be in this study for 10 years and we will collect information about your health.

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The social brain study

Lead Researcher: David Dodell-feder

The purpose of this study is to learn how people with schizophrenia think about other people when in social situations. The study involves three parts, which will be completed on separate days: 1. Clinical interviews, questionnaires, paper-and-pencil and computerized assessments of cognition (4-6 hours, which can be completed in multiple sessions) 2. Magnetic resonance imaging (MRI) scan (2 hours) 3. Daily diary questionnaire (7 days, 5 minutes/day)

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The Treatment of Progressive Early Onset Spinal Deformities: A Multi-Center Outcome Study

The purpose of this study is to examine the treatment, both surgical and non-surgical, of patients with any form of early onset scoliosis. Such treatment may include the use of growth friendly devices that are surgically or magnetically lengthened; or the use of serial body casting or bracing, or observation. Outcomes examined will be what can be seen physically on the patient and on x-ray, as well as parent perception of how the treatment effects their child with the use of a health-related quality of life (HRQOL) questionnaire.

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Trametinib and Docetaxel in Treating Patients With Recurrent or Stage IV KRAS Mutation Positive Non-small Cell Lung Cancer

This phase II trial studies how well trametinib and docetaxel work in treating patients with stage IV KRAS mutation positive non-small cell lung cancer or cancer that has come back. Trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving trametinib with docetaxel may work better in treating non-small cell lung cancer.

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Umbilical Cord Blood Transplantation From Unrelated Donors

Lead Researcher: Omar Aljitawi

This study is a single-center treatment protocol with four possible preparative regimens, designed to validate the process of umbilical cord blood stem cell transplantation at our institution. Enrolled patients will receive chemotherapy +/- total body radiation as a pre-transplant conditioning regimen. Patients will then receive cord blood stem cells followed by prevention drugs for graft versus host disease. Multiple data points will be collected prior to, during, and following transplantation to ensure safety of the process and to evaluate the stated objectives.

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Upper GI Tract Cancer: 12 week home-based exercise study

Lead Researcher: Richard Dunne

We would also like to find out if this exercise intervention improves physical performance, day-to-day function, quality of life, and how the exercise may affect markers of inflammation in the blood over time. Cancer cachexia is a complex condition that can result in weight loss, muscle weakness, and/or tiredness, and may affect your normal daily activities and quality of life. Cachexia is common in patients with upper gastrointestinal tract cancers (esophageal, stomach, bile duct or liver cancer, and pancreatic cancer). There is little information on how these symptoms may develop or change as cachexia progresses, or how exercise may help improve these symptoms. Currently more information is needed on how physical performance and quality of life is affected by cachexia. There are no drugs approved for cachexia so understanding cachexia and its effect on the body may guide the development of interventions to help other patients with cancer cachexia.

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Uterine Cancer Treatment: Lenvatinib in Combination With Pembrolizumab Versus Physician's Choice

Lead Researcher: Richard Moore

This is a study of pembrolizumab (MK-3475, KEYTRUDA®) in combination with lenvatinib (E7080) versus treatment of physician's choice (doxorubicin or paclitaxel) for the treatment of advanced endometrial (uterine) cancer. Participants will be randomly assigned to receive either pembrolizumab and lenvatinib or treatment of physician's choice. The primary study hypothesis is that pembrolizumab in combination with lenvatinib prolongs progression free survival (PFS) and overall survival (OS) when compared to treatment of physician's choice.

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Valganciclovir Therapy in Infants and Children With Congenital CMV Infection and Hearing Loss

This is an international, multi-center, double-blind, placebo-controlled evaluation valganciclovir treatment for up to 54 children (up to 4 years of age) with virologically-confirmed congenital CMV infection and hearing loss. Subject participation will be over a six-month period and study subjects will be stratified according to age. The primary objective is to assess whether a six-week course of oral valganciclovir can stabilize the hearing of children with congenital CMV infection who present with hearing loss.

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Vemurafenib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With BRAF V600 Mutations (A Pediatric MATCH Treatment Trial)

This phase II Pediatric MATCH trial studies how well vemurafenib works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with BRAF V600 mutations that have spread to other places in the body and have come back or do not respond to treatment. Vemurafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

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VX15/2503 Treatment for Huntington's Disease

The purpose of this study is to evaluate the safety, tolerability, PK, and efficacy of VX15/2503 in subjects with late prodromal and early manifest Huntington's disease.

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Whole-Brain Radiation Therapy With or Without Hippocampal Avoidance in Treating Patients With Limited Stage or Extensive Stage Small Cell Lung Cancer

This randomized phase II/III trial studies how well whole-brain radiation therapy works and compares it with or without hippocampal avoidance in treating patients with small cell lung cancer that is found in one lung, the tissues between the lungs, and nearby lymph nodes only (limited stage) or has spread outside of the lung in which it began or to other parts of the body (extensive stage). Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. The hippocampus is part of the brain that is important for memory. Avoiding the hippocampus during whole-brain radiation could decrease the chance of side effects on memory and thinking. It is not yet known whether giving whole-brain radiation therapy is more effective with or without hippocampal avoidance in treating patients with small cell lung cancer.

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Whole-Food, Plant-Based Nutrition Among Women with Metastatic Breast Cancer

Lead Researcher: Thomas Campbell

Women will be given free, prepared food for 8 weeks, along with a multivitamin, and will attend weekly office visits. Women will be assessed at the beginning of the study and after eating the food for 8 weeks, in addition to a blood test after 3 weeks. There will also be a Control Group of women that will eat their regular diet and take a provided multivitamin.

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Zenith® Low Profile AAA Endovascular Graft

The Zenith® Low Profile AAA Endovascular Graft Clinical Study is a clinical trial to study the safety and effectiveness of the Zenith® Low Profile AAA Endovascular Graft used in conjunction with the Zenith® Spiral-Z® AAA Iliac Leg Graft to treat abdominal aortic, aortoiliac, and iliac aneurysms.

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