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.
NCT04463771 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 206
Last updated 2025-12-10
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
Interventions
- DRUG
-
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
Sponsors & Collaborators
-
GOG Foundation
collaborator NETWORK -
European Network of Gynaecological Oncological Trial Groups (ENGOT)
collaborator OTHER - lead INDUSTRY
Principal Investigators
-
Mark Cornfield · Incyte Corporation
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-01-26
- Primary Completion
- 2026-04-14
- Completion
- 2026-07-10
- FDA Drug
- Yes
Countries
- United States
- Belgium
- France
- Georgia
- Germany
- Greece
- Italy
Study Locations
More Related Trials
-
Upifitamab Rilsodotin Maintenance in Platinum-Sensitive Recurrent Ovarian Cancer (UP-NEXT)
NCT05329545 ·Status: TERMINATED ·Phase: PHASE3
-
Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Mismatch Repair Deficient (dMMR) Advanced or Recurrent Endometrial Carcinoma (MK-3475-C93/KEYNOTE-C93/GOG-3064/ENGOT-en15)
NCT05173987 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
A Study of D4064A Administered to Patients With Recurrent or Persistent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
NCT00753480 ·Status: SUSPENDED ·Phase: PHASE1
-
A Study of Pembrolizumab in Combination With Epacadostat in Women With Recurrent/Metastatic Endometrial Carcinoma
NCT03310567 ·Status: WITHDRAWN ·Phase: PHASE2
-
Testing the Addition of the Immunotherapy Drug Pembrolizumab to the Usual Chemotherapy Treatment (Paclitaxel and Carboplatin) in Stage III-IV or Recurrent Endometrial Cancer
NCT03914612 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
A Study of Oral Gimatecan in Platinum-Resistant Epithelial Ovarian, Fallopian Tube or Peritoneal Cancer
NCT04846842 ·Status: UNKNOWN ·Phase: PHASE2
-
S9720 Combination Chemotherapy in Treating Patients With Metastatic, Recurrent, or Refractory Endometrial Cancer
NCT00003127 ·Status: COMPLETED ·Phase: PHASE2
-
Cabozantinib S-malate and Nivolumab in Treating Patients With Advanced, Recurrent, or Metastatic Endometrial Cancer
NCT03367741 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
QUILT-3.051: NANT Ovarian Cancer Vaccine: Combination Immunotherapy in Subjects With Epithelial Ovarian Cancer Who Have Progressed on or After Standard-of-care (SoC) Therapy
NCT03197584 ·Status: WITHDRAWN ·Phase: PHASE1/PHASE2
-
Study of Navtemadlin as Maintenance Therapy in TP53WT Advanced or Recurrent Endometrial Cancer
NCT05797831 ·Status: RECRUITING ·Phase: PHASE2/PHASE3
-
A Phase II Study of Anlotinib Combined With Penpulimab in Subjects With Gynecological Cancer
NCT05028504 ·Status: RECRUITING ·Phase: PHASE2
-
Sacituzumab Govitecan in Combination With Cisplatin in Platinum Sensitive Recurrent Ovarian and Endometrial Cancer
NCT06040970 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
A Phase II Study of Futibatinib and Pembrolizumab in Metastatic Microsatellite Stable Endometrial Carcinoma
NCT05036681 ·Status: TERMINATED ·Phase: PHASE2
-
RC88 in Platinum-Resistant Recurrent Epithelial Ovarian Cancer, Fallopian Tube Cancer, and Primary Peritoneal Cancer
NCT06173037 ·Status: COMPLETED ·Phase: PHASE2
-
GEN1046 in Combination With Anticancer Agents for the Treatment of Advanced Endometrial Cancer
NCT06046274 ·Status: WITHDRAWN ·Phase: PHASE2
-
Chemoimmunotherapy Study for Patients With Epithelial Ovarian Cancer
NCT00501644 ·Status: COMPLETED ·Phase: PHASE2
-
Carboxyamidotriazole in Treating Patients With Refractory or Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
NCT00019461 ·Status: COMPLETED ·Phase: PHASE2
-
Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Participants With Endometrial Cancer After Platinum-Based Chemotherapy and Immunotherapy (ASCENT-GYN-01/GOG-3104/ENGOT-en26)
NCT06486441 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
A Study to Evaluate rhuMab 2C4 and Gemcitabine in Subjects With Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
NCT00096993 ·Status: COMPLETED ·Phase: PHASE2
-
Polyglutamate Paclitaxel and Carboplatin in Treating Patients With Ovarian Epithelial, Peritoneal, or Fallopian Tube Cancer
NCT00060359 ·Status: COMPLETED ·Phase: PHASE1
-
Copanlisib in Treating Patients With Persistent or Recurrent Endometrial Cancer
NCT02728258 ·Status: COMPLETED ·Phase: PHASE2
-
Nivolumab With or Without Ipilimumab in Treating Patients With Recurrent or High Grade Gynecologic Cancer With Metastatic Peritoneal Carcinomatosis
NCT03508570 ·Status: COMPLETED ·Phase: PHASE1
-
Lenvatinib, Pembrolizumab, and Paclitaxel for Treatment of Recurrent Endometrial, Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
NCT04781088 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Intraperitoneal Paclitaxel, Doxorubicin Hydrochloride, and Cisplatin in Treating Patients With Stage III-IV Endometrial Cancer
NCT00575952 ·Status: COMPLETED ·Phase: PHASE1
-
Trebananib in Treating Patients With Persistent or Recurrent Endometrial Cancer
NCT01210222 ·Status: COMPLETED ·Phase: PHASE2