NCT04463771

Safety and Efficacy of Retifanlimab (INCMGA00012) Alone or in Combination With Other Therapies in Participants With Advanced or Metastatic Endometrial Cancer Who Have Progressed on or After Platinum-based Chemotherapy.

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)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 206 (actual)
• Sponsor: Incyte Corporation · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Endometrial Cancer

Interventions

Type	Name	Description
DRUG	retifanlimab	INCMGA00012 administered intravenously on Day 1 of each 28-day cycle for up to 26 cycles.
DRUG	epacadostat	epacadostat will be administered orally BID.
DRUG	pemigatinib	pemigatinib will be administered orally QD.
DRUG	INCAGN02385	INCAGN2385 will be administered every 2 weeks
DRUG	INCAGN02390	INCAGN2390 will be administered every 2 weeks

Timeline

• Start date: 2021-01-26
• Primary completion: 2026-04-14
• Completion: 2026-07-10
• First posted: 2020-07-09
• Last updated: 2025-12-10

Locations

65 sites across 7 countries: United States, Belgium, France, Georgia, Germany, Greece, Italy

Regulatory

• FDA-regulated drug study