Retifanlimab
DrugINCMGA00012 administered intravenously on Day 1 of each 28-day cycle for up to 26 cycles.
Other names: INCMGA00012
NCT Number: NCT04463771
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.
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Notify Me18 year and older
Female
Interventional
Phase 2
O.L.V Ziekenhuis, Aalst, Belgium
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
INCMGA00012 administered intravenously on Day 1 of each 28-day cycle for up to 26 cycles.
Other names: INCMGA00012
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
Time frame: up to 2.5 years
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
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
Defined as the proportion of participants with CR, PR, or SD (as determined by ICR) as best response.
Time frame: up to 3.5 years
Defined as the time from the first dose of study treatment until death due to any cause.
Time frame: up to 3.5 years
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 2.5 years
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
Defined as the proportion of participants with CR, PR, or SD (as determined by ICR) as best response.
Time frame: up to 3.5 years
Defined as the time from the first dose of study treatment until death due to any cause.
Time frame: up to 2 years
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 3.5 years
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 2 years
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 4 years
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.
Incyte Corporation
Industry
An Umbrella Study of INCMGA00012 Alone and in Combination With Other Therapies in Participants With Advanced or Metastatic Endometrial Cancer Who Have Progressed on or After Platinum-Based Chemotherapy (POD1UM-204)
Acronym: POD1UM-204
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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