This is a multicenter, open-label, nonrandomized, Phase 2 umbrella study of retifanlimab in participants who have advanced or metastatic endometrial cancer that has progressed on or after platinum-based chemotherapy. retifanlimab will be administered as monotherapy or in combination with other immunotherapy or targeted agents.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
206
INCMGA00012 administered intravenously on Day 1 of each 28-day cycle for up to 26 cycles.
epacadostat will be administered orally BID.
pemigatinib will be administered orally QD.
INCAGN2385 will be administered every 2 weeks
INCAGN2390 will be administered every 2 weeks
Alaska Womens Cancer Care Akwcc
Anchorage, Alaska, United States
Honorhealth
Phoenix, Arizona, United States
Arizona Oncology Associates
Tucson, Arizona, United States
UCLA Medical Hematology & Oncology
Los Angeles, California, United States
Olive View Med Ctr
Sylmar, California, United States
Group A - Objective Response Rate
Defined as the proportion of participants having a CR or PR according to RECIST v1.1, as assessed by Independent Central Review committee
Time frame: up to 2.5 years
Group A -Duration of Response
Defined as the time from the first documented objective response (CR or PR) according to RECIST v1.1 (as determined by ICR) until disease progression or death due to any cause.
Time frame: up to 2.5 years
Group A - Disease Control Rate
Defined as the proportion of participants with CR, PR, or SD (as determined by ICR) as best response.
Time frame: up to 2.5 years
Group A - Overall Survival
Defined as the time from the first dose of study treatment until death due to any cause.
Time frame: up to 3.5 years
Group A - Progression Free Survival
Defined as the time from the first dose of study treatment until disease progression (as determined by ICR) or death due to any cause.
Time frame: up to 3.5 years
Group B -Duration of Response
Defined as the time from the first documented objective response (CR or PR) according to RECIST v1.1 (as determined by ICR) until disease progression or death due to any cause.
Time frame: up to 2.5 years
Group B - Disease Control Rate
Defined as the proportion of participants with CR, PR, or SD (as determined by ICR) as best response.
Time frame: up to 2.5 years
Group B - Overall Survival
Defined as the time from the first dose of study treatment until death due to any cause.
Time frame: up to 3.5 years
Groups B - Objective Response Rate
Defined as the proportion of participants having a CR or PR according to RECIST v1.1, as assessed by Independent Central Review committee
Time frame: up to 2 years
Group B - Progression Free Survival
Defined as the time from the first dose of study treatment until disease progression (as determined by ICR) or death due to any cause.
Time frame: up to 3.5 years
Groups C, D, E and F - Objective Response Rate
Defined as the proportion of participants having a CR or PR according to RECIST v1.1, as assessed by Independent Central Review committee
Time frame: up to 2 years
Number of Treatment-Related Adverse Events
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.
Time frame: up to 4 years
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Broward Health Medical Center
Fort Lauderdale, Florida, United States
Miami Cancer Institute
Miami, Florida, United States
Mount Sinai Medical Center Comprehensive Cancer Center
Miami Beach, Florida, United States
Advent Health Medical Group-Orlando 2501
Orlando, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute Hospital
Tampa, Florida, United States
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