Multiple Cancers: A Study Exploring the Safety and Efficacy of INCAGN01949 in Combination
With Immune Therapies in Advanced or Metastatic Malignancies
What is the safety and tolerability of INCAGN01949, how is INCAGN01949 broken down
and eliminated from the body, how does INCAGN01949 act in and on the body, and what
are the effects that INCAGN01949 have on your cancer when combined with nivolumab
Basic Study Information
Purpose:Location: Cancer Center
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.
Study Web URL: https://clinicaltrials.gov/ct2/show/NCT03241173?term=1949-201&rank=1
Study Reference #: IMLT17105
Lead Researcher (Principal Investigator)
Lead Researcher: Marcus Noel
Study Contact InformationStudy Coordinator: Kari Steinmetz
Phone: (585) 276-4447
Additional Study Details
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