A clinical trial is a research study involving human volunteers, and is designed to answer specific health questions. Carefully conducted clinical trials are the safest and fastest way to find effective treatments, and new ways to improve health.
You can search for all studies that are currently enrolling participants at the University of Rochester by typing in keywords in the search box below. If you don’t find a study that interests you right now, consider signing up for our Volunteer Registry, which will notify you of future studies.
*EA2182 / RGIC19164 / DECREASE / Haoming Qiu
Lead Researcher: Haoming Qiu
This phase II trial studies how well lower-dose chemotherapy plus radiation (chemoradiation)
therapy works in comparison to standard-dose chemoradiation in treating patients with
early-stage anal cancer. Drugs used in chemotherapy, such as mitomycin, fluorouracil,
and capecitabine, 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 x-rays to kill tumor cells and shrink tumors. Giving
chemotherapy with radiation therapy may kill more tumor cells. This study may help
doctors find out if lower-dose chemoradiation is as effective and has fewer side effects
than standard-dose chemoradiation, which is the usual approach for treatment of this
cancer type.
View Study Details
A022101 ERASur / CRGIC23031 / Alliance / QIU
Lead Researcher: Haoming Qiu
This phase III trial compares total ablative therapy and usual systemic therapy to
usual systemic therapy alone in treating patients with colorectal cancer that has
spread to up to 4 body sites (limited metastatic). The usual approach for patients
who are not participating in a study is treatment with intravenous (IV) (through a
vein) and/or oral medications (systemic therapy) to help stop the cancer sites from
getting larger and the spread of the cancer to additional body sites. Ablative means
that the intention of the local treatment is to eliminate the cancer at that metastatic
site. The ablative local therapy will consist of very focused, intensive radiotherapy
called stereotactic ablative radiotherapy (SABR) with or without surgical resection
and/or microwave ablation, which is a procedure where a needle is temporarily inserted
in the tumor and heat is used to destroy the cancer cells. SABR, surgical resection,
and microwave ablation have been tested for safety, but it is not scientifically proven
that the addition of these treatments are beneficial for your stage of cancer. The
addition of ablative local therapy to all known metastatic sites to the usual approach
of systemic therapy could shrink or remove the tumor(s) or prevent the tumor(s) from
returning.
View Study Details
A041703 / CLEU19006 / O'Dwyer, Kristen
Lead Researcher: Kristen O'Dwyer
This phase II trial studies how well inotuzumab ozogamicin and blinatumomab work in
treating patients with CD22-positive B-lineage acute lymphoblastic leukemia that is
newly diagnosed, has come back, or does not respond to treatment. Immunotherapy with
monoclonal antibodies, such as inotuzumab ozogamicin and blinatumomab, may help the
body's immune system attack the cancer, and may interfere with the ability of tumor
cells to grow and spread.
View Study Details
A081801 / RLUN20119 / ALCHEMIST-IO (ACCIO) / Yuhchyau Chen
Lead Researcher: Yuhchyau Chen
This phase III ALCHEMIST trial tests the addition of pembrolizumab to usual chemotherapy
for the treatment of stage IIA, IIB, IIIA or IIIB non-small cell lung cancer that
has been removed by surgery. Immunotherapy with monoclonal antibodies, such as pembrolizumab,
may help the body's immune system attack the cancer, and may interfere with the ability
of tumor cells to grow and spread. Chemotherapy drugs, such as cisplatin, pemetrexed,
carboplatin, 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. Giving pembrolizumab with usual chemotherapy
may help increase survival times in patients with stage IIA, IIB, IIIA or IIIB non-small
cell lung cancer.
View Study Details
A151216 ALCHEMIST Screening Protocol
Lead Researcher: Yuhchyau Chen
This 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.
View Study Details
Algo TX
Lead Researcher: Jennifer Gewandter
The purpose of this clinical trial is to compare the efficacy of twice daily applications
of ATX01 (10% & 15%) versus placebo during a 12-week treatment period in treating
chemotherapy-induced peripheral neuropathy (CIPN) in adult cancer survivor patients.
View Study Details
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.
View Study Details
CBRS21001 / A011801 / Dhakal
Lead Researcher: Ajay Dhakal
This phase III trial studies how well trastuzumab emtansine (T-DM1) and tucatinib
work in preventing breast cancer from coming back (relapsing) in patients with high
risk, HER2 positive breast cancer. T-DM1 is a monoclonal antibody, called trastuzumab,
linked to a chemotherapy drug, called DM1. Trastuzumab is a form of targeted therapy
because it attaches to specific molecules (receptors) on the surface of cancer cells,
known as HER2 receptors, and delivers DM1 to kill them. Tucatinib may stop the growth
of tumor cells by blocking some of the enzymes needed for cell growth. Giving T-DM1
and tucatinib may work better in preventing breast cancer from relapsing in patients
with HER2 positive breast cancer compared to T-DM1 alone.
View Study Details
CGIP20087 / A021806 / Richard Dunne
Lead Researcher: Daniel Mulkerin
This phase III trial compares perioperative chemotherapy (given before and after surgery)
versus adjuvant chemotherapy (given after surgery) for the treatment of pancreatic
cancer that can be removed by surgery (removable/resectable). Chemotherapy drugs,
such as fluorouracil, irinotecan, leucovorin, and oxaliplatin, 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 chemotherapy before and after
surgery (perioperatively) may work better in treating patients with pancreatic cancer
compared to giving chemotherapy after surgery (adjuvantly).
View Study Details
CGUK20101 / A031704 / Deepak Sahasrabudhe
Lead Researcher: Deepak Sahasrabudhe
This phase III trial compares the usual treatment (treatment with ipilimumab and nivolumab
followed by nivolumab alone) to treatment with ipilimumab and nivolumab, followed
by nivolumab with cabozantinib in patients with untreated renal cell carcinoma that
has spread to other parts of the body. The addition of cabozantinib to the usual treatment
may make it work better. 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. Cabozantinib may stop the growth
of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet
known how well the combination of cabozantinib and nivolumab after initial treatment
with ipilimumab and nivolumab works in treating patients with renal cell cancer that
has spread to other parts of the body.
View Study Details
CGUK20147 / S1931 / Frye
Lead Researcher: Thomas Frye
This phase III trial compares the effect of adding surgery to a standard of care immunotherapy-based
drug combination versus a standard of care immunotherapy-based drug combination alone
in treating patients with kidney cancer that has spread to other places in the body
(metastatic). Immunotherapy with monoclonal antibodies, such as nivolumab, ipilimumab,
pembrolizumab, and avelumab, may help the body's immune system attack the cancer,
and may interfere with the ability of tumor cells to grow and spread. Axitinib may
stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Surgery to remove the kidney, called a nephrectomy, is also considered standard of
care; however, doctors who treat kidney cancer do not agree on its benefits. It is
not yet known if the addition of surgery to an immunotherapy-based drug combination
works better than an immunotherapy-based drug combination alone in treating patients
with kidney cancer.
View Study Details
CGUP18150 / S1802 / Chunkit Fung
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.
View Study Details
CGYO20085 / NRG-CC008 / Richard Moore
Lead Researcher: Richard Moore
This clinical trial studies how well two surgical procedures (bilateral salpingectomy
and bilateral salpingo-oophorectomy) work in reducing the risk of ovarian cancer for
individuals with BRCA1 mutations. Bilateral salpingectomy involves the surgical removal
of fallopian tubes, and bilateral salpingo-oophorectomy involves the surgical removal
of both the fallopian tubes and ovaries. This study may help doctors determine if
the two surgical procedures are nearly the same for ovarian cancer risk reduction
for women with BRCA1 mutations.
View Study Details
CHAN19107 / EA3161 / Megan Baumgart
Lead Researcher: Megan Baumgart
This phase III trials 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 (throat 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.
View Study Details
CHAN21104 / NRG-HN009 / Patel
Lead Researcher: Arpan Patel
This phase II/III trial compares the effect of the combination of high-dose cisplatin
every three weeks and radiation therapy versus low-dose cisplatin weekly and radiation
therapy for the treatment of patients with locoregionally advanced head and neck cancer.
Chemotherapy drugs, 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 x-rays to kill tumor cells
and shrink tumors. This study is being done to find out if low-dose cisplatin given
weekly together with radiation therapy is the same or better than high-dose cisplatin
given every 3 weeks together with radiation therapy in treating patients with head
and neck cancer.
View Study Details
CLEU20105/ S1905/ Kristen O'Dwyer
Lead Researcher: Kristen O'Dwyer
This phase II trial studies how well OBI-3424 works in treating patients with T-cell
acute lymphoblastic leukemia that has come back (relapsed) or does not response to
treatment (refractory). Drugs used in chemotherapy, such as OBI-3424, 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. OBI-3424 may reduce the amount
of leukemia in the body.
View Study Details
CLEU20136 / EA9181 / O'Dwyer
Lead Researcher: Kristen O'Dwyer
This phase III trial compares the effect of usual treatment of chemotherapy and steroids
and a tyrosine kinase inhibitor (TKI) to the same treatment plus blinatumomab. Blinatumomab
is a Bi-specific T-Cell Engager ('BiTE') that may interfere with the ability of cancer
cells to grow and spread. The information gained from this study may help researchers
determine if combination therapy with steroids, TKIs, and blinatumomab work better
than the standard of care.
View Study Details
CLUN19026 / LUNGMAP / Megan Baumgart
Lead Researcher: Megan Baumgart
This screening and multi-sub-study randomized phase II/III trial will establish a
method for genomic screening of similar large cancer populations followed by assigning
and accruing simultaneously to a multi-sub-study hybrid Master Protocol (Lung-MAP).
The type of cancer trait (biomarker) will determine to which sub-study, within this
protocol, a participant will be assigned to compare new targeted cancer therapy, designed
to block the growth and spread of cancer, or combinations to standard of care therapy
with the ultimate goal of being able to approve new targeted therapies in this setting.
In addition, the protocol includes non-match sub-studies which will include all screened
patients not eligible for any of the biomarker-driven sub-studies.
View Study Details
CLUN21035 / S1900E / Baumgart
Lead Researcher: Megan Baumgart
This phase II Lung-MAP treatment trial studies the effect of AMG 510 in treating non-squamous
non-small cell lung cancer that is stage IV or has come back (recurrent) and has a
specific mutation in the KRAS gene, known as KRAS G12C. Mutations in this gene may
cause the cancer to grow. AMG 510, a targeted treatment against the KRAS G12C mutation,
may help stop the growth of tumor cells.
View Study Details
CLYM17097 / S1608 / Paul Barr
Lead Researcher: Paul Barr
This phase II trial studies how well obinutuzumab with or without umbralisib, lenalidomide,
or combination chemotherapy work in treating patients with grade I-IIIa follicular
lymphoma that has come back (relapsed) or does not respond to treatment (refractory).
Immunotherapy with obinutuzumab, may induce changes in body's immune system and may
interfere with the ability of tumor cells to grow and spread. Umbralisib may stop
the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Biological therapies, such as lenalidomide, use substances made from living organisms
that may stimulate or suppress the immune system in different ways and stop cancer
cells from growing. Chemotherapy drugs, such as cyclophosphamide, doxorubicin, vincristine,
prednisone, and bendamustine, 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. It is not yet known whether giving obinutuzumab with or without
umbralisib, lenalidomide, or combination chemotherapy will work better in treating
patients with grade I-IIIa follicular lymphoma.
View Study Details
CLYM17103 / EA4151 / Paul Barr
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.
View Study Details
CLYM19123 / AALL1731 / Kazi
Lead Researcher: Rafi Kazi
This phase III trial studies how well blinatumomab works in combination with chemotherapy
in treating patients with newly diagnosed, standard risk B-lymphoblastic leukemia
or B-lymphoblastic lymphoma with or without Down syndrome. Monoclonal antibodies,
such as blinatumomab, may induce changes in the body's immune system and may interfere
with the ability of cancer cells to grow and spread. Chemotherapy drugs, such as vincristine,
dexamethasone, prednisone, prednisolone, pegaspargase, methotrexate, cytarabine, mercaptopurine,
doxorubicin, cyclophosphamide, and thioguanine, 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. Leucovorin decreases the toxic effects of methotrexate.
Giving monoclonal antibody therapy with chemotherapy may kill more cancer cells. Giving
blinatumomab and combination chemotherapy may work better than combination chemotherapy
alone in treating patients with B-ALL. This trial also assigns patients into different
chemotherapy treatment regimens based on risk (the chance of cancer returning after
treatment). Treating patients with chemotherapy based on risk may help doctors decide
which patients can best benefit from which chemotherapy treatment regimens.
View Study Details
CLYM20151 / S1925 / Barr
Lead Researcher: Paul Barr
This phase III trial compares early treatment with venetoclax and obinutuzumab versus
delayed treatment with venetoclax and obinutuzumab in patients with newly diagnosed
high-risk chronic lymphocytic leukemia or small lymphocytic lymphoma. Venetoclax is
in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop
the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival.
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. Starting treatment with the venetoclax and obinutuzumab early
(before patients have symptoms) may have better outcomes for patients with chronic
lymphocytic leukemia or small lymphocytic lymphoma compared to starting treatment
with the venetoclax and obinutuzumab after patients show symptoms.
View Study Details
CLYM21071 / S2005 / Zent
Lead Researcher: Clive Zent
This phase II trial studies the effects of venetoclax and rituximab in comparison
to ibrutinib and rituximab in treating patients with previously untreated Waldenstrom's
macroglobulinemia/lymphoplasmacytic lymphoma. Ibrutinib may stop the growth of cancer
cells by blocking some of the enzymes needed for cell growth. Rituximab is a monoclonal
antibody. It binds to a protein called CD20, which is found on B cells (a type of
white blood cell) and some types of cancer cells. This may help the immune system
kill cancer cells. Venetoclax is in a class of medications called B-cell lymphoma-2
(BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein
needed for cancer cell survival. Giving venetoclax and rituximab may work better in
treating patients with previously untreated Waldenstrom's macroglobulinemia than ibrutinib
and rituximab alone.
View Study Details
CLYM21088 / ANHL1931 / Casulo
Lead Researcher: Carla Casulo
This phase III trial compares the effects of nivolumab with chemo-immunotherapy versus
chemo-immunotherapy alone in treating patients with newly diagnosed primary mediastinal
B-cell lymphoma (PMBCL). Immunotherapy with monoclonal antibodies, such as nivolumab,
may help the body's immune system attack the cancer, and may interfere with the ability
of cancer cells to grow and spread. Treatment for PMBCL involves chemotherapy combined
with an immunotherapy called rituximab. Chemotherapy drugs 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. Rituximab is a monoclonal antibody.
It binds to a protein called CD20, which is found on B cells (a type of white blood
cell) and some types of cancer cells. This may help the immune system kill cancer
cells. Giving nivolumab with chemo-immunotherapy may help treat patients with PMBCL.
View Study Details
CMBRS23057 / Weiss / A012103
Lead Researcher: Anna Weiss
The phase III trial compares the effect of pembrolizumab to observation for the treatment
of patients with early-stage triple-negative breast cancer who achieved a pathologic
complete response after preoperative chemotherapy in combination with pembrolizumab.
Immunotherapy with monoclonal antibodies, such as pembrolizumab, 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 may help researchers determine if observation will
result in the same risk of cancer coming back as pembrolizumab after surgery in triple-negative
breast cancer patients who achieve pathologic complete response after preoperative
chemotherapy with pembrolizumab.
View Study Details
CMGIC22093 // A022104 // BADRI
Lead Researcher: Nabeel Badri
This phase II trial compares the effect of irinotecan versus oxaliplatin after long-course
chemoradiation in patients with stage II-III rectal cancer. Combination chemotherapy
drugs, such as FOLFIRINOX (fluorouracil, irinotecan, leucovorin, and oxaliplatin),
FOLFOX (leucovorin, fluorouracil, oxaliplatin, and irinotecan ), and CAPOX (capecitabin
and oxaliplatin) 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.
FOLFOX or CAPOX are used after chemoradiation as usual treatment for rectal cancer.
Giving FOLFIRINOX after chemoradiation may increase the response rate and lead to
higher rates of clinical complete response (with a chance of avoiding surgery) compared
to FOLFOX or CAPOX after chemoradiation in patients with locally advanced rectal cancer.
View Study Details
CMGIC23011 // NRG-GI008 // McGreevy
Lead Researcher: Maria McGreevy
This Phase II/III trial will evaluate the what kind of chemotherapy to recommend to
patients based on the presence or absences of circulating tumor DNA (ctDNA) after
surgery for colon cancer.
View Study Details
CMGYN23001_Moore_NRG-GY026
Lead Researcher: Richard Moore
This phase II/III trial tests whether adding trastuzumab and hyaluronidase-oysk (Herceptin
HylectaTM) or pertuzumab, trastuzumab and hyaluronidase-zzxf (PhesgoTM) to the usual
chemotherapy (paclitaxel and carboplatin) works to shrink tumors in patients with
HER2 positive endometrial serous carcinoma or carcinosarcoma. Trastuzumab and pertuzumab
are monoclonal antibodies and forms of targeted therapy that attach to specific molecules
(receptors) on the surface of tumor cells, known as HER2 receptors. When trastuzumab
or pertuzumab attach to HER2 receptors, the signals that tell the cells to grow are
blocked and the tumor cell may be marked for destruction by the body's immune system.
Hyaluronidase is an endoglycosidase. It helps to keep pertuzumab and trastuzumab in
the body longer, so that these medications will have a greater effect. Hyaluronidase
also allows trastuzumab and trastuzumab/pertuzumab to be given by injection under
the skin and shortens their administration time compared to trastuzumab or pertuzumab
alone. Paclitaxel is a taxane and in a class of medications called antimicrotubule
agents. It stops cancer cells from growing and dividing and may kill them. Carboplatin
is in a class of medications known as platinum-containing compounds. It works in a
way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin.
Carboplatin works by killing, stopping or slowing the growth of tumor cells. Giving
Herceptin Hylecta or Phesgo in combination with paclitaxel and carboplatin may shrink
the tumor and prevent the cancer from coming back in patients with HER2 positive endometrial
serous carcinoma or carcinosarcoma.
View Study Details
CMGYN23039_Moore_NRG-GY025
Lead Researcher: Richard Moore
This phase II trial tests whether the combination of nivolumab and ipilimumab is better
than nivolumab alone to shrink tumors in patients with deficient mismatch repair system
(dMMR) endometrial carcinoma that has come back after a period of time during which
the cancer could not be detected (recurrent). Deoxyribonucleic acid (DNA) mismatch
repair (MMR) is a system for recognizing and repairing damaged DNA. In 2-3% of endometrial
cancers this may be due to a hereditary condition resulted from gene mutation called
Lynch Syndrome (previously called hereditary nonpolyposis colorectal cancer or HNPCC).
MMR deficient cells usually have many DNA mutations. Tumors that have evidence of
mismatch repair deficiency tend to be more sensitive to immunotherapy. There is some
evidence that nivolumab with ipilimumab can shrink or stabilize cancers with deficient
mismatch repair system. However, it is not known whether this will happen in endometrial
cancer; therefore, this study is designed to answer that question. 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 nivolumab
in combination with ipilimumab may be better than nivolumab alone in treating dMMR
recurrent endometrial carcinoma.
View Study Details
CMLEU23033 // A042001 // O'Dwyer
Lead Researcher: Kristen O'Dwyer
This phase II trial compares the combination of inotuzumab ozogamicin and chemotherapy
to the usual chemotherapy in treating patients with B-cell acute lymphoblastic leukemia
or B-cell lymphoblastic lymphoma. Inotuzumab ozogamicin is a monoclonal antibody,
called inotuzumab, linked to a drug, called CalichDMH. Inotuzumab is a form of targeted
therapy because it attaches to specific molecules (receptors) on the surface of cancer
cells, known as CD22 receptors, and delivers CalichDMH to kill them. Chemotherapy
drugs 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
inotuzumab ozogamicin with chemotherapy may help shrink the cancer and stop it from
returning.
View Study Details
CMLT20100 / S1823 / Chunkit Fung
Lead Researcher: Chunkit Fung
This trial studies whether the blood marker micro ribonucleic acid (miRNA) 371 can
predict the chance of cancer returning in patients with germ cell cancers. Studying
samples of blood from patients with germ cell cancers in the laboratory may help doctors
predict how likely the cancer will come back.
View Study Details
CMLUN23010 // S2302 // MULFORD
Lead Researcher: Deborah Mulford
This phase III trial compares the effect of the combination of ramucirumab and pembrolizumab
versus standard of care chemotherapy for the treatment of non-small cell lung cancer
that is stage IV or that has come back after a period of improvement (recurrent).
Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels
that tumors need to grow. Immunotherapy with monoclonal antibodies, such as pembrolizumab,
may help the body's immune system attack the cancer, and may interfere with the ability
of tumor cells to grow and spread. Chemotherapy drugs 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. This trial may help doctors find out if giving
ramucirumab with pembrolizumab is more effective at treating patients with stage IV
or recurrent non-small cell lung cancer than standard chemotherapy.
View Study Details
CMLYM23020 // S2114 // Reagan
Lead Researcher: Patrick Reagan
This phase II trial tests whether mosunetuzumab and/or polatuzumab vedotin helps benefit
patients who have received chemotherapy (fludarabine and cyclophosphamide) followed
by chimeric antigen receptor (CAR) T-cell therapy (tisagenlecleucel, axicabtagene
ciloleucel, or lisocabtagene maraleucel) for diffuse large B-cell lymphoma that has
come back (recurrent) or that does not respond to treatment (refractory) or grade
IIIb follicular lymphoma. Mosunetuzumab is a monoclonal antibody that may interfere
with the ability of cancer cells to grow and spread. Polatuzumab vedotin is a monoclonal
antibody, called polatuzumab, linked to a drug called vedotin. Polatuzumab is a form
of targeted therapy because it attaches to specific molecules (receptors) on the surface
of cancer cells, and delivers vedotin to kill them. Chemotherapy drugs, such as fludarabine
and cyclophosphamide, 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.
CAR T-cell therapy is a type of treatment in which a patient's T cells (a type of
immune system cell) are changed in the laboratory so they will attack cancer cells.
T cells are taken from a patient's blood. Then the gene for a special receptor that
binds to a certain protein on the patient's cancer cells is added to the T cells in
the laboratory. The special receptor is called a chimeric antigen receptor. Large
numbers of the CAR T cells are grown in the laboratory and given to the patient by
infusion for treatment of certain cancers. Giving mosunetuzumab and/or polatuzumab
vedotin after chemotherapy and CAR T-cell therapy may be more effective at controlling
or shrinking the cancer than not giving them.
View Study Details
CMLYM23030 // AHOD2131 // Casulo
Lead Researcher: Carla Casulo
This phase III trial compares the effect of adding immunotherapy (brentuximab vedotin
and nivolumab) to standard treatment (chemotherapy with or without radiation) to the
standard treatment alone in improving survival in patients with stage I and II classical
Hodgkin lymphoma. Brentuximab vedotin is in a class of medications called antibody-drug
conjugates. It is made of a monoclonal antibody called brentuximab that is linked
to a cytotoxic agent called vedotin. Brentuximab attaches to CD30 positive lymphoma
cells in a targeted way and delivers vedotin to kill them. A monoclonal antibody is
a type of protein that can bind to certain targets in the body, such as molecules
that cause the body to make an immune response (antigens). 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. Chemotherapy
drugs such as doxorubicin hydrochloride, bleomycin sulfate, vinblastine sulfate, dacarbazine,
and procarbazine hydrochloride 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. Cyclophosphamide is in a class of medications called alkylating
agents. It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill cancer
cells. It may also lower the body's immune response. Etoposide is in a class of medications
known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division
and DNA repair and may kill cancer cells. Vincristine is in a class of medications
called vinca alkaloids. It works by stopping cancer cells from growing and dividing
and may kill them. Prednisone is in a class of medications called corticosteroids.
It is used to reduce inflammation and lower the body's immune response to help lessen
the side effects of chemotherapy drugs. Radiation therapy uses high energy x-rays
to kill tumor cells and shrink tumors. Adding immunotherapy to the standard treatment
of chemotherapy with or without radiation may increase survival and/or fewer short-term
or long-term side effects in patients with classical Hodgkin lymphoma compared to
the standard treatment alone.
View Study Details
CMLYM23075 // A052101 // Wallace
Lead Researcher: Danielle Wallace
This phase III trial tests whether continuous or intermittent zanubrutinib after achieving
a complete remission (CR) with rituximab works in older adult patients with mantle
cell lymphoma (MCL) who have not received treatment in the past (previously untreated).
Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells
to grow and spread. Zanubrutinib may stop the growth of cancer cells by blocking some
of the enzymes needed for cell growth. When zanubrutinib is used in MCL, the current
standard of care is to continue administering the drug indefinitely until disease
progression. This continuous treatment comes with clinical as well as financial toxicity,
which could be especially detrimental in older patients. For patients who achieve
a CR after initial zanubrutinib plus rituximab therapy, it may be safe and equally
effective to stop treatment and restart zanubrutinib upon disease progression rather
than continuing indefinitely in previously untreated older adult patients with MCL.
View Study Details
CMMMY23044 // S2209 // Lipe
Lead Researcher: Brea Lipe
This phase III trial compares three-drug induction regimens followed by double-or
single-drug maintenance therapy for the treatment of newly diagnosed multiple myeloma
in patients who are not receiving a stem cell transplant and are considered frail
or intermediate-fit based on age, comorbidities, and functional status. Treatment
for multiple myeloma includes initial treatment (induction) which is the first treatment
a patient receives for cancer followed by ongoing treatment (maintenance) which is
given after initial treatment to help keep the cancer from coming back. There are
three combinations of four different drugs being studied. Bortezomib is one of the
drugs that may stop the growth of cancer cells by blocking some of the enzymes needed
for cell growth. Lenalidomide works by helping bone marrow to produce normal blood
cells and killing cancer cells. Anti-inflammatory drugs, such as dexamethasone, lower
the body's immune response and are used with other drugs in the treatment of some
types of cancer. Daratumumab and hyaluronidase-fihj is a monoclonal antibody that
may interfere with the ability of cancer cells to grow and spread. Patients receive
1 of 3 combinations of these drugs for treatment to determine which combination of
study drugs works better to shrink and control multiple myeloma.
View Study Details
CPLEU23006 // ASCT2031 // Andolina
Lead Researcher: Jeffrey Andolina
This phase III trial compares hematopoietic (stem) cell transplantation (HCT) using
mismatched related donors (haploidentical [haplo]) versus matched unrelated donors
(MUD) in treating children, adolescents, and young adults with acute leukemia or myelodysplastic
syndrome (MDS). HCT is considered standard of care treatment for patients with high-risk
acute leukemia and MDS. In HCT, patients are given very high doses of chemotherapy
and/or radiation therapy, which is intended to kill cancer cells that may be resistant
to more standard doses of chemotherapy; unfortunately, this also destroys the normal
cells in the bone marrow, including stem cells. After the treatment, patients must
have a healthy supply of stem cells reintroduced or transplanted. The transplanted
cells then reestablish the blood cell production process in the bone marrow. The healthy
stem cells may come from the blood or bone marrow of a related or unrelated donor.
If patients do not have a matched related donor, doctors do not know what the next
best donor choice is. This trial may help researchers understand whether a haplo related
donor or a MUD HCT for children with acute leukemia or MDS is better or if there is
no difference at all.
View Study Details
CPSAR23078 / Kazi / ARST2032
Lead Researcher: Rafi Kazi
Rhabdomyosarcoma is a type of cancer that occurs in the soft tissues in the body.
This phase III trial aims to maintain excellent outcomes in patients with very low
risk rhabdomyosarcoma (VLR-RMS) while decreasing the burden of therapy using treatment
with 24 weeks of vincristine and dactinomycin (VA) and examines the use of centralized
molecular risk stratification in the treatment of rhabdomyosarcoma. Another aim of
the study it to find out how well patients with low risk rhabdomyosarcoma (LR-RMS)
respond to standard chemotherapy when patients with VLR-RMS and patients who have
rhabdomyosarcoma with DNA mutations get separate treatment. Finally, this study examines
the effect of therapy intensification in patients who have RMS cancer with DNA mutations
to see if their outcomes can be improved.
View Study Details
CRLUN22012 / NRG-CC009 / Milano
Lead Researcher: Michael Milano
This phase III trial compares the effect of stereotactic radiosurgery to standard
of care memantine and whole brain radiation therapy that avoids the hippocampus (the
memory zone of the brain) for the treatment of small cell lung cancer that has spread
to the brain. Stereotactic radiosurgery is a specialized radiation therapy that delivers
a single, high dose of radiation directly to the tumor and may cause less damage to
normal tissue. Whole brain radiation therapy delivers a low dose of radiation to the
entire brain including the normal brain tissue. Hippocampal avoidance during whole-brain
radiation therapy (HA-WBRT) decreases the amount of radiation that is delivered to
the hippocampus which is a brain structure that is important for memory. The drug,
memantine, is also often given with whole brain radiotherapy because it may decrease
the risk of side effects related to thinking and memory. Stereotactic radiosurgery
may decrease side effects related to memory and thinking compared to standard of care
HA-WBRT plus memantine.
View Study Details
DRO2001 / RGUP20045 / Prostate HDR Brachy / Hong Zhang
Lead Researcher: Hong Zhang
The purpose of this study is to learn more about what effects the use of high-dose-rate
(HDR) brachytherapy on prostate cancer recurrence, seen by AXUMIN PET scan, has on
prostate cancer.
View Study Details
DRO2005 / RHAN20083 / ALTENS / Michael Cummings
Lead Researcher: Michael Cummings
The purpose of this study would like to learn if acupuncture-like electrical therapy
can be used in patients with head and neck cancer who have had radiation treatment
to treat dry mouth.
View Study Details
DRO2102 / URGUP23077 / Zhang
Lead Researcher: Hong Zhang
This study will establish the preferred dose of lisinopril in men with non-metastatic
prostate cancer undergoing radiation treatment. This study will also evaluate the
effect of lisinopril on urinary symptoms and the impact of lisinopril on biomarkers
and their association with urinary symptoms.
View Study Details
DRO72835 / ULUN18075 / Lung 3 vs 5 Fx SBRT / Deepinder Singh
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.
View Study Details
Evaluation of multiple biomarkers to estimate risk of cancer in gynecology patients
presenting with a pelvic mass
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
of the cells.
View Study Details
IBRS19007 / FLEX Registry / Ajay Dhakal
Lead Researcher: Ajay Dhakal
The FLEX Registry will be implemented to operate as a large-scale, population based,
prospective registry. All patients with stage I to III breast cancer who receive MammaPrint®
and BluePrint testing on a primary breast tumor are eligible for entry into the FLEX
Registry, which is intended to enable additional study arms at low incremental effort
and cost. FLEX Registry will utilize an adaptive design, where additional targeted
substudies and arms can be added after the initial study is opened.
View Study Details
IMBRS22048_Dhakal_Celcuity CELC-G-301 Gedatolisib
Lead Researcher: Ajay Dhakal
This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy
and safety of gedatolisib plus fulvestrant with or without palbociclib for the treatment
of patients with locally advanced or metastatic HR+/HER2- breast cancer following
progression on or after CDK4/6 and aromatase inhibitor therapy.
View Study Details
IMBRS23027_Falkson_J2J-MC-JZLH - EMBER-4
Lead Researcher: Carla Falkson
The main purpose of this study is to measure how well imlunestrant works compared
to standard hormone therapy in participants with early breast cancer that is estrogen
receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants
must have already taken endocrine therapy for two to five years and must have a higher-than-average
risk for their cancer to return. Study participation could last up to 10 years.
View Study Details
IMGIP22070 / CL-SBP-101-04 / Dunne
Lead Researcher: Richard Dunne
The study is a randomized, double-blind, placebo-controlled, multicenter study of
standard treatment with nab-paclitaxel and gemcitabine with or without SBP-101 in
subjects previously untreated for metastatic pancreatic ductal adenocarcinoma (PDA),
including subjects who have received prior neoadjuvant or adjuvant treatment.
View Study Details
IMLEU22035 / CA-4948-102 / Liesveld
Lead Researcher: Jane Liesveld
This is a multicenter, open-label, Phase 1/2a dose escalation and expansion study
of orally administered emavusertib (CA-4948) monotherapy in adult patients with Acute
Myelogenous Leukemia (AML) or high risk Myelodysplastic Syndrome (MDS).
Patients enrolling in the Phase 1 portion of the study must meet one of the following
criteria prior to consenting to the study:
R/R AML with FLT3 mutations who have been previously treated with a FLT3 inhibitor
R/R AML with spliceosome mutations of SF3B1 or U2AF1
R/R hrMDS with spliceosome mutations of SF3B1 or U2AF1
Number of pretreatments: 1 or 2
The Phase 2a Dose Expansion will be in 3 Cohorts of patients:
R/R AML with FLT3 mutations who have been previously treated with a FLT3 inhibitor;
R/R AML with spliceosome mutations of SF3B1 or U2AF1; and
R/R hrMDS (IPSS-R score > 3.5) with spliceosome mutations of SF3B1 or U2AF1.
All patients above have had ≤ 2 lines of prior systemic anticancer treatment. In previous
versions of this protocol there was a Phase 1b portion of the study, in which patients
with AML or hrMDS received CA-4948 in combination with venetoclax. This part of the
study is no longer open for enrollment.
View Study Details
IMLYM22090 // M23-647 // Barr
Lead Researcher: Paul Barr
Non-Hodgkin's lymphoma (NHL) is a cancer that arises from the transformation of normal
B and T lymphocytes (white blood cells). The purpose of this study is to assess the
safety, pharmacokinetics, and preliminary efficacy of ABBV-101 in adult participants
in relapsed or refractory (R/R) non-Hodgkin's lymphomas: third line or later of treatment
(3L) + chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), diffuse
large b-cell lymphoma (DLBCL), non-germinal center B cell (GCB) DLBCL, mantle cell
lymphoma (MCL), follicular lymphoma (FL), marginal zone lymphoma (MZL), Waldenström
macroglobulinemia (WM), or transformed indolent NHL. Adverse events will be assessed.
ABBV-101 is an investigational drug being developed for the treatment of NHL. This
study will include a dose escalation phase to determine the maximum administered dose
(MAD)/Maximum tolerated dose (MTD) of ABBV-101 and a dose expansion phase to determine
the change in disease activity in participants with CLL or non-GCB DLBCL. Approximately
128 adult participants with multiple NHL subtypes will be enrolled in the study in
sites world wide.
In the Dose Escalation phase of the study participants will receive escalating oral
doses of ABBV-101, until the MAD/MTD is determined, as part of the approximately 60
month study duration. In the dose expansion phase of the study participants receive
oral ABBV-101, as part of the approximately 60 month study duration .
There may be higher treatment burden for participants in this trial compared to their
standard of care. Participants will attend regular visits during the study at an approved
institution (hospital or clinic). The effect of the treatment will be frequently checked
by medical assessments, blood tests, and side effects.
View Study Details
ISCR2201MN (Nucleix)
Lead Researcher: Michael Nead
This study is part of the development and validation of a non-invasive lung screening
test which aim to identify early stage lung cancer in patients at high risk for lung
cancer.
View Study Details
ISCR2202MN (DELFI)
Lead Researcher: Michael Nead
CASCADE-LUNG is an event-driven, multisite, prospective, observational, blood specimen
collection study in the elevated-risk lung cancer screening population. The primary
objective is to determine the sensitivity and specificity of the Delfi Lung Cancer
ScreeningTest (DLCST).
View Study Details
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.
View Study Details
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.
View Study Details
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.
View Study Details
NRG-BN012 / CRNEU23065 / Milano
Lead Researcher: Michael Milano
This phase III trial compares the addition of stereotactic radiosurgery before or
after surgery in treating patients with cancer that has spread to the brain (brain
metastases). Stereotactic radiosurgery is a type of radiation therapy that delivers
a high dose of radiation only to the small areas of cancer in the brain and avoids
the surrounding normal brain tissue. Surgery and radiation may stop the tumor from
growing for a few months or longer and may reduce symptoms of brain metastases.
View Study Details
NRG-BR008 HERO / CRBRS23022 / Gergelis
Lead Researcher: Kimberly Gergelis
This Phase III trial compares the recurrence-free interval (RFI) among patients with
early-stage, low risk HER2+ breast cancer who undergo breast conserving surgery and
receive HER2-directed therapy, and are randomized to not receive adjuvant breast radiotherapy
versus those who are randomized to receive adjuvant radiotherapy per the standard
of care.
View Study Details
NRG-GU008 / RGUP20037 / INNOVATE / Hong Zhang
Lead Researcher: Hong Zhang
This phase III trial studies whether adding apalutamide to the usual treatment improves
outcome in patients with lymph node positive prostate cancer after surgery. Radiation
therapy uses high energy x-ray to kill tumor cells and shrink tumors. Androgens, or
male sex hormones, can cause the growth of prostate cancer cells. Drugs, such as apalutamide,
may help stop or reduce the growth of prostate cancer cell growth by blocking the
attachment of androgen to its receptors on cancer cells, a mechanism similar to stopping
the entrance of a key into its lock. Adding apalutamide to the usual hormone therapy
and radiation therapy after surgery may stabilize prostate cancer and prevent it from
spreading and extend time without disease spreading compared to the usual approach.
View Study Details
NRG-GU009 / RGUP21002 / PREDICT-RT / Kevin Bylund
Lead Researcher: Kevin Bylund
This phase III trial compares less intense hormone therapy and radiation therapy to
usual hormone therapy and radiation therapy in treating patients with high risk prostate
cancer and low gene risk score. This trial also compares more intense hormone therapy
and radiation therapy to usual hormone therapy and radiation therapy in patients with
high risk prostate cancer and high gene risk score. Apalutamide may help fight prostate
cancer by blocking the use of androgen by the tumor cells. Radiation therapy uses
high energy rays to kill tumor cells and shrink tumors. Giving a shorter hormone therapy
treatment may work the same at controlling prostate cancer compared to the usual 24
month hormone therapy treatment in patients with low gene risk score. Adding apalutamide
to the usual treatment may increase the length of time without prostate cancer spreading
as compared to the usual treatment in patients with high gene risk score.
View Study Details
NRG-GU010 / RGUP21107 / GUIDANCE / Michael Cummings
Lead Researcher: Michael Cummings
This phase III trial uses the Decipher risk score to guide intensification (for higher
Decipher gene risk) or de-intensification (for low Decipher gene risk) of treatment
to better match therapies to an individual patient's cancer aggressiveness. The Decipher
risk score evaluates a prostate cancer tumor for its potential for spreading. In patients
with low risk scores, this trial compares radiation therapy alone to the usual treatment
of radiation therapy and hormone therapy (androgen deprivation therapy). Radiation
therapy uses high energy x-rays or particles to kill tumor cells and shrink tumors.
Androgen deprivation therapy blocks the production or interferes with the action of
male sex hormones such as testosterone, which plays a role in prostate cancer development.
Giving radiation treatment alone may be the same as the usual approach in controlling
the cancer and preventing it from spreading, while avoiding the side effects associated
with hormonal therapy. In patients with higher Decipher gene risk, this trial compares
the addition of darolutamide to usual treatment radiation therapy and hormone therapy,
to usual treatment. Darolutamide blocks the actions of the androgens (e.g. testosterone)
in the tumor cells and in the body. The addition of darolutamide to the usual treatment
may better control the cancer and prevent it from spreading.
View Study Details
NRG-LU008 / CRLUN23043 / NRG / QIU
Lead Researcher: Haoming Qiu
This phase III trial compares the effect of adding stereotactic body radiation therapy
(SBRT) to standard treatment (image guided radiation therapy [IGRT] and chemotherapy
followed by immunotherapy with durvalumab) versus standard treatment alone in treating
patients with non-small cell lung cancer that cannot be treated by surgery (inoperable).
SBRT uses special equipment to position a patient and deliver radiation to tumors
with high precision. This method may kill tumor cells with fewer doses over a shorter
period and cause less damage to normal tissue. IGRT is a type of radiation that uses
a computer to create picture of the tumor, to help guide the radiation beam during
therapy, making it more accurate and causing less damage to healthy tissue. Standard
chemotherapy used in this trial consists of combinations of the following drugs: cisplatin,
carboplatin, paclitaxel, pemetrexed, and etoposide. Cisplatin is in a class of medications
known as platinum-containing compounds. It works by killing, stopping or slowing the
growth of tumor cells. Carboplatin is in a class of medications known as platinum-containing
compounds. It works in a way similar to the anticancer drug cisplatin, but may be
better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing
the growth of tumor cells. Paclitaxel is in a class of medications called antimicrotubule
agents. It works by stopping the growth and spread of tumor cells. Pemetrexed is in
a class of medications called antifolate antineoplastic agents. It works by blocking
the action of a certain substance in the body that may help tumor cells multiply.
Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks
a certain enzyme needed for cell division and DNA repair and may kill tumor cells.
Immunotherapy with durvalumab, may induce changes in body's immune system and may
interfere with the ability of tumor cells to grow and spread. Adding SBRT to the standard
treatment of IGRT with chemotherapy and immunotherapy may be more effective at treating
patients with inoperable non-small cell lung cancer than giving the standard treatment
alone.
View Study Details
PCCO15102 / APEC14B1 / EveryChild Protocol / Kazi
Lead Researcher: Rafi Kazi
This study gathers health information for 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.
View Study Details
PGUK06001 / AREN03B2 / Kazi
Lead Researcher: Rafi Kazi
This research trial studies kidney tumors in younger patients. Collecting and storing
samples of tumor tissue, blood, and urine from patients with cancer to study in the
laboratory may help doctors learn more about changes that occur in deoxyribonucleic
acid (DNA) and identify biomarkers related to cancer.
View Study Details
PLEU19175 / AALL1732 / Kazi
Lead Researcher: Rafi Kazi
This phase III trial studies whether inotuzumab ozogamicin added to post-induction
chemotherapy for patients with High-Risk B-cell Acute Lymphoblastic Leukemia (B-ALL)
improves outcomes. This trial also studies the outcomes of patients with mixed phenotype
acute leukemia (MPAL), and B-lymphoblastic lymphoma (B-LLy) when treated with ALL
therapy without inotuzumab ozogamicin. Inotuzumab ozogamicin is a monoclonal antibody,
called inotuzumab, linked to a type of chemotherapy called calicheamicin. Inotuzumab
attaches to cancer cells in a targeted way and delivers calicheamicin to kill them.
Other drugs used in the chemotherapy regimen, such as cyclophosphamide, cytarabine,
dexamethasone, doxorubicin, daunorubicin, methotrexate, leucovorin, mercaptopurine,
prednisone, thioguanine, vincristine, and pegaspargase or calaspargase pegol 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. This trial will
also study the outcomes of patients with mixed phenotype acute leukemia (MPAL) and
disseminated B lymphoblastic lymphoma (B-LLy) when treated with high-risk ALL chemotherapy.
The overall goal of this study is to understand if adding inotuzumab ozogamicin to
standard of care chemotherapy maintains or improves outcomes in High Risk B-cell Acute
Lymphoblastic Leukemia (HR B-ALL). The first part of the study includes the first
two phases of therapy: Induction and Consolidation. This part will collect information
on the leukemia, as well as the effects of the initial treatment, to classify patients
into post-consolidation treatment groups. On the second part of this study, patients
with HR B-ALL will receive the remainder of the chemotherapy cycles (interim maintenance
I, delayed intensification, interim maintenance II, maintenance), with some patients
randomized to receive inotuzumab. The patients that receive inotuzumab will not receive
part of delayed intensification. Other aims of this study include investigating whether
treating both males and females with the same duration of chemotherapy maintains outcomes
for males who have previously been treated for an additional year compared to girls,
as well as to evaluate the best ways to help patients adhere to oral chemotherapy
regimens. Finally, this study will be the first to track the outcomes of subjects
with disseminated B-cell Lymphoblastic Leukemia (B-LLy) or Mixed Phenotype Acute Leukemia
(MPAL) when treated with B-ALL chemotherapy.
View Study Details
PMLT12010 / ALTE05N1 / Mullen
Lead Researcher: Rafi Kazi
This clinical trial keeps track of and collects follow-up information from patients
who are currently enrolled on or have participated in a Children's Oncology Group
study. Developing a way to keep track of patients who have participated in Children's
Oncology Group studies may allow doctors learn more about the long-term effects of
cancer treatment and help them reduce problems related to treatment and improve patient
quality of life.
View Study Details
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.
View Study Details
RGUP21115 / NRG-GU011 / PROMETHEAN / Zhang
Lead Researcher: Hong Zhang
This phase II trial tests whether relugolix and radiation therapy works to shrink
tumors in patients with prostate cancer that has spread in a limited way to 1 to 5
other parts of the body (oligometastatic). Testosterone can cause the growth of prostate
cancer cells. Relugolix lowers the amount of testosterone made by the body. This may
help stop the growth of tumor cells that need testosterone to grow. Giving relugolix
with radiation therapy may help lower the chance of prostate cancer growing or spreading.
View Study Details
RTOG 1216 / RHAN13055 / Surgery and Postoperative Radiation / Yuhchyau Chen
Lead Researcher: Yuhchyau Chen
This phase II/III trial studies how well radiation therapy works when given together
with cisplatin, docetaxel, cetuximab, and/or atezolizumab after surgery in treating
patients with high-risk stage III-IV head and neck cancer the begins in the thin,
flat cells (squamous cell). 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. Drugs used in chemotherapy, such as cisplatin and docetaxel, work
in different ways to stop the growth of tumor cells, either by killing the cells or
by stopping them from dividing. Cetuximab is a monoclonal antibody that may interfere
with the ability of tumor cells to grow and spread. Immunotherapy with monoclonal
antibodies, such as atezolizumab, may help the body's immune system attack the cancer,
and may interfere with the ability of tumor cells to grow and spread. The purpose
of this study is to compare the usual treatment (radiation therapy with cisplatin
chemotherapy) to using radiation therapy with docetaxel and cetuximab chemotherapy,
and using the usual treatment plus an immunotherapy drug, atezolizumab.
View Study Details
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.
View Study Details
Study of T900607-Sodium in Chemotherapy Naive Patients With Hepatocellular Carcinoma.
The purpose of the study is to determine whether T900607-sodium is effective and safe
in
treating hepatocellular carcinoma, a type of liver cancer.
View Study Details
SWAT BE
Lead Researcher: Vivek Kaul
The purpose of this research study is to learn about the best approach to sample patients
with known or suspected Barrett's esophagus (BE) by comparing the standard Seattle
biopsy protocol to sampling using wide area transepithelial sampling (WATS3D).
Barrett's esophagus is a common condition that is used to spot patients at increased
risk of developing a type of cancer in the esophagus (swallowing tube) called esophageal
adenocarcinoma. The 5-year survival rate is as low as 18% for patients who get esophageal
adenocarcinoma, but the rate may be improved if the cancer is caught in its early
stages. Barrett's esophagus can lead to dysplasia, or precancerous changes, which
occurs when cells look abnormal but have not developed into cancer. If the abnormal
cells increase from being slightly abnormal (low-grade dysplasia), to being very abnormal
(high-grade dysplasia), the risk of developing cancer (esophageal adenocarcinoma)
goes up. Therefore, catching dysplasia early is very important to prevent cancer.
Endoscopic surveillance is a type of procedure where endoscopists run a tube with
a light and a camera on the end of it down a patients throat and remove a small piece
of tissue. The piece of tissue, called a biopsy, is about the size of the tip of a
ball-point pen and is checked for abnormal cells and cancer cells.
Patients are being asked to be in this research study because they have been diagnosed
with BE or suspected to have BE, and will need an esophagogastroduodenoscopy (EGD).
Patients with BE undergo sampling using the Seattle biopsy protocol during which samples
are obtained from the BE in a four quadrant fashion every 2 cm along with target biopsies
from any abnormal areas within the BE. Another sampling approach is WATS3D which utilizes
brushings from the BE.
While both of these procedures are widely accepted approaches to sampling patients
with BE during endoscopy, there is not enough research to show if one is better than
the other.
Participants in this study will undergo sampling of the BE using both approaches (Seattle
biopsy protocol and WATS-3D); the order of the techniques will be randomized.
Up to 2700 participants will take part in this research. This is a multicenter study
involving several academic, community and private hospitals around the country.
View Study Details
Total-Body Irradiation, Fludarabine, and Peripheral Stem Cell Transplantation in Treating
Patients With Hematologic Cancer
RATIONALE: Radiation therapy uses high-energy x-rays to damage cancer cells. Drugs
used in
chemotherapy use different ways to stop cancer cells from dividing so they stop growing
or
die. Combining chemotherapy with donor peripheral stem cell transplantation may allow
the
doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining total-body irradiation
with
fludarabine and donor peripheral stem cell transplantation in treating patients who
have
hematologic cancer.
View Study Details
UBMT17044 / HBO-UBC / Omar Aljitawi
Lead Researcher: Omar Aljitawi
The UCB transplant is a type of stem cell transplant used to treat cancer of the blood
or lymph glands. The UCB transplant has advantages over other types of transplants
such as ease of obtaining the umbilical cord blood, absence of donor risks, reduced
risks of contagious infections, and the availability for immediate use. The UCB transplant
is also associated with a lower incidence of graft versus host disease, or GvHD (in
GvHD, the transplanted graft attacks the recipient organs).
View Study Details
UBRS20139 / FACT-5 / Ajay Dhakal
Lead Researcher: Ajay Dhakal
The purpose of this research is to look at the safety and effectiveness of a HER2-targeted
therapy neratinib when given with capecitabine, a chemotherapy, for breast cancer
patients with brain metastases whose tumors were HER2-negative by standard tests but
showed abnormal HER2 activity based on the CELsignia results.
View Study Details
UBRS20152 / BTCRC BRE15-024 / O'Regan
Lead Researcher: Ruth O'Regan
This is an open label, multi-institutional, single arm phase II trial of ribociclib
in combination with bicalutamide in advanced AR+ triple-negative breast cancer. No
randomization or blinding is involved.
View Study Details
UBRS21032 / HCRN-BRE17-141 / O'Regan
Lead Researcher: Ruth O'Regan
Patient will be treated with neratinib, an aromatase inhibitor and trastuzumab for
24 weeks prior to surgery, following an initial 3 weeks of neratinib alone, aromatase
inhibitor alone or the combination of neratinib and an aromatase inhibitor. A breast
biopsy will be performed prior to Day 1 of week 4 of treatment. Following surgery,
patients will receive standard of care HER2-directed and endocrine therapy at the
treating physician's discretion.
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UBRT21040 / Early START / Sara Hardy
Lead Researcher: Sara Hardy
High grade gliomas (HGGs) are rapidly progressive brain tumors resulting in death
for most patients between 6 months and 2 years after diagnosis. It is important for
patients with HGG to discuss and document their wishes at the end of life. However,
many of these patients experience early changes in cognition which impede their decision-making.
For this reason, these patients should have early discussions with their providers.
However, implementation of this remains challenging in clinical practice.
In this study, we will create an Early STructured Advanced care Referrals by Telehealth
(Early START) visit for patients soon after their initial oncology visit. A checklist
and pre-visit guide were developed to help guide the visit for both the provider and
patient. Providers will receive special training in running these visits. Caregivers
and/or family members will be encouraged to participate. Visits will be done using
video or telephone and recorded. For patients who do not have access to technology
for these visits, it will be provided. After the visit, patients, caregivers and/or
family who participated, and providers will fill out surveys to address feasibility
of having these extra visits and improve the visits for future. Patients will be followed
until death. Caregivers and/or family who participated will be asked about whether
end of life was in line with the patient's wishes. We will also use the patient's
medical record to assess other aspects of end of life. We will compare end of life
outcomes with other similar patients treated at our center.
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UBRT21074 / BRV / Wychowski
Lead Researcher: Thomas Wychowski
The purpose of this study is to determine whether the study medication, brivaracetam,
is tolerable and safe for patients with brain tumors.
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UCCS19102 / MAAT-G JIT (Breast) / Magnuson
Lead Researcher: Allison Magnuson
Cancer-related cognitive dysfunction (CRCD) affects up to 75% of patients receiving
chemotherapy and older adults are at greater risk of developing CRCD, which can negatively
affect their functional independence and quality of life. Memory and Attention Adaptation
Training (MAAT) is a promising treatment for CRCD that improves perceived cognition
in younger cancer survivors, but needs to be adapted for older adults to address their
unique needs. The proposed study will adapt MAAT for older adults using feedback from
key stakeholders (older adults with cancer and their caregivers), and subsequently
test the ability of MAAT to improve or maintain cognition for older adults with breast
cancer receiving adjuvant chemotherapy.
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UCCS21043 / Go-EXCAP II / Loh
Lead Researcher: Kah Poh Loh
This is a phase 2 randomized controlled trial (RCT) to assess the preliminary efficacy
of the a mobile health exercise intervention (GO-EXCAP) versus a chemotherapy education
control in 100 older patients with MN receiving outpatient chemotherapy on physical
function and patient-reported outcomes (fatigue, mood, and quality of life). We will
also explore the effect of the intervention on TNFα and related cytokine gene promoter
methylation and their gene and protein expression.
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UCCS21065 / Dyadic Life Review / Lee Kehoe
Lead Researcher: Lee Kehoe
The purpose of this study is to test the feasibility of a telehealth Dyadic Life Review
(DLR), adapted from individual Life Review Therapy, with caregivers of older adults
with advanced cancer, including those with Mild Cognitive Impairment (MCI). The study
will enroll 20 dyads of caregivers and older patients with advanced cancer and 20
dyads of caregivers and patients with advanced cancer and Mild Cognitive Impairment
(MCI).
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UGUB20041, Guercio, HCRN GU18-343, Urinary Bladder Neoplasms, Cabozantinib, Atezolizumab
Lead Researcher: Brendan Guercio
This is an open-label phase II study assessing the activity of cabozantinib combined
with atezolizumab in patients with resectable muscle-invasive urothelial carcinoma
who are ineligible for cisplatin-based therapy or decline cisplatin-based therapy.
Each cycle equals 21 days. The dose of atezolizumab is 1200 mg IV flat dose every
3 weeks (Day 1) plus cabozantinib 40 mg orally daily (Day 1 through Day 21). Patients
will receive three cycles of treatment prior to cystectomy unless they discontinue
treatment for unacceptable toxicity or progressive disease by RECIST v1.1 or withdraw
consent.
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UGUK17036 / Fung RCC Carevive Pilot IIT / Chunkit Fung
Lead Researcher: Chunkit Fung
To determine if Carevive software, which monitors treatment-related toxicities and
then generates self-care management plans for these symptoms, will be feasible to
implement among patients with metastatic renal cell carcinoma (RCC). Additionally
for collection of preliminary data on treatment-related toxicities, quality of life,
distress level, and drug adherence.
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UGUP18071 / DORA / Chunkit Fung
Lead Researcher: Chunkit Fung
The purpose of this study is to compare any good and bad effects of using radium-223
along with docetaxel chemotherapy treatment versus using docetaxel alone. Earlier
studies helped show that the combination is safe, but the combination has not been
proven to work better than either drug alone. The goal of this study is to find out
if combining docetaxel and radium-223 is better than giving either drug by itself.
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ULEU07047 / RSRB20123 / Michael Becker
Lead Researcher: Jane Liesveld
This study is being performed to develop assays to determine the impact of the therapy
patients receive for treatment of AML or MDS and to determine if these tests can identify
those patients who are at a greater risk for having their disease relapse.
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ULUN19148 / Pembrolizumab NSCLC / Megan Baumgart
Lead Researcher: Megan Baumgart
The purpose of this study is to understand if treatment with one chemotherapy medication
combined with immune therapy (pembrolizumab) is tolerable and effective for patients
with lung cancer and performance status of 2 (PS2), which means you have limitations
in carrying out certain activities or spend up to half of your day resting.
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ULYM18040 / DLBCL / Carla Casulo
Lead Researcher: Carla Casulo
The overarching goals of this study are to measure 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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UMLT19186 / K08 JIT / Ramsdale
Lead Researcher: Erika Ramsdale
This is a single-site cluster-randomized trial to assess efficacy and implementation
outcomes of deprescribing interventions in 72 older adults with polypharmacy (PP)
and curable cancers initiating chemotherapy. Oncologists (as the cluster) will enroll
6 patients each and will be randomized to either a pharmacist-led deprescribing intervention
or patient education intervention. Initial focus groups with oncologists, nurses,
pharmacists, primary care physicians, and patients will provide data for initial adaptations
to the pharmacist-led intervention arm, and 8 patients will be enrolled as a pre-trial
cohort to further refine and adapt the pharmacist-led intervention.
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UMLT20123 / Van Veldhuizen / SMM & Prostate
Lead Researcher: Brea Lipe
To explore the use of curcumin and piperine supplementation at a dose of 4 gram/5mg
twice a day in early stage prostate cancer patient undergoing active surveillance
or patients on observation for MGUS/ low-risk smoldering myeloma.
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UMMY19160/Hyperbaric Oxygen/ Omar Aljitawi
Lead Researcher: Omar Aljitawi
Subjects with multiple myeloma (MM) who are considered eligible for high-dose therapy
and autologous stem cell transplantation by the transplant team at WCI will be enrolled
in the study.
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UOCPC22008 / Triadic / Magnuson
Lead Researcher: Allison Magnuson
To gather key stakeholder input for feedback on the adaption of the COACH GA intervention
(i.e., develop COACH-Cog) to enhance triadic communication among oncologists, care
partners and patients with ADRD.
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UOCPC22010 / UR-GOAL 2 / Kah Poh Loh
Lead Researcher: Kah Poh Loh
The objective of this study is to conduct a pilot randomized trial to evaluate the
preliminary efficacy of the UR-GOAL tool vs. usual care in improving shared decision
making and communication between 100 older patients with AML and their oncologists.
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UOCPC22022 / E-Co Study / Kah Poh Loh
Lead Researcher: Kah Poh Loh
The objective of the study is to evaluate the feasibility of a combined mobile health
exercise and cognitive rehabilitation intervention and its effect on cognition in
a single-arm pilot study that recruits cancer survivors.
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UOCPC22065 / SONATA / Kah Poh Loh
Lead Researcher: Kah Poh Loh
The purpose of this study is to see if a social network support program (SOcial Networks
to Activate Trust & Adherence or SONATA) is helpful for older individuals receiving
cancer treatment. The SONATA program will last for about 4 months. There are a total
of 6 coaching sessions. The first 5 sessions will be held approximately every 1 to
2 weeks. Session 6 or the final session will be held approximately 1 to 2 months after
session 5. Each session will last for about 1 to 2 hours.
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VAPOR 2 Study Pivotal Study Clinical Protocol/Frye/IUGUP23019
Lead Researcher: Thomas Frye
The purpose of this study is to evaluate the safety and efficacy of the Vanquish Water
Vapor Ablation Device ("Vanquish") in treating subjects with Gleason Grade Group 2
(GGG2) localized intermediate-risk prostate cancer.
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