Clinical trial · Interventional
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| epacadostat | Drug | — | UNRESOLVED |
| INCAGN02385 | Drug | — | UNRESOLVED |
| INCAGN02390 | Drug | — | UNRESOLVED |
| pemigatinib | Drug | Pemigatinib | ALIAS |
| retifanlimab | Drug | Retifanlimab | ALIAS |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- Group A - retifanlimab
- description
- Select participants naïve to checkpoint inhibitors will be administered retifanlimab intravenously
- interventionNames
- Drug: retifanlimab
- type
- EXPERIMENTAL
- label
- Group B - retifanlimab
- description
- Select participants naïve to checkpoint inhibitors will be administered retifanlimab intravenously
- interventionNames
- Drug: retifanlimab
- type
- EXPERIMENTAL
- label
- Group C - retifanlimab + epacadostat
- description
- Select participants who are allowed on prior checkpoint inhibitors will be administered retifanlimab intravenously in combination with oral epacadostat (IDO1 inhibitor)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Ability to comprehend and willingness to sign a written ICF for the study. Note for Germany: This excludes individuals who are housed in an institution due to official or court order Women 18 years of age or older (or as applicable per local country requirements). * Histologically confirmed diagnosis of advanced or metastatic endometrial cancer with disease progression on or after treatment with at least 1 platinum-containing regimen for advanced or metastatic disease. * Groups A, B, and E: Have not been previously treated with a PD-(L)1 inhibitor. * Group A only: Tumor tissue tested as MSI-High * Group B only: Tumor tissue tested as deficient MMR or an ultra-mutated POLE tumor. * Group D only: Tumor tissue tested as having an FGFR 1,2,3 mutation or alteration characterized as per protocol. * Group E: Tumor tissue tested as MSS and PD-L1 positive. * Group F: Radiological evidence of disease progression on or after prior PD (L)1 therapy and Tumor tissue tested as MSI-H * Must have at least 1 measurable tumor lesion per RECIST v1.1. * Willing to provide tumor tissue sample (fresh or archived). * ECOG performance status 0 to 1. * Willingness to avoid pregnancy. Exclusion Criteria: * Group A, B and E only: Histologically confirmed diagnosis of carcinosarcoma of the uterus. * Histologically confirmed diagnosis of sarcoma of the uterus. * Has disease eligible for potentially curative treatment. * Receipt of anticancer therapy within 28 days of the first administration of study treatment, with the exception of localized radiotherapy. * Toxicity of prior therapy that has not recovered to ≤ Grade 1 or baseline unless approved by the medical monitor. * Groups C, D and F (combinations): limiting immune-related toxicity during prior checkpoint inhibitor therapy. * Group F only: Previous treatment with LAG-# or TIM-3 therapy or lenvatinib; multiple metastases that achieved mixed tumor response to prior anti-PD-(L)1 therapy * Has an active autoimmune disease requiring systemic immunosuppression with corticosteroids (\> 10 mg/day of prednisone or equivalent) or immunosuppressive drugs within 14 days before the first dose of study treatment. * Receiving chronic systemic steroids (\> 10 mg/day of prednisone or equivalent): * Known active CNS metastases and/or carcinomatous meningitis. * Has known active hepatitis B or C. * Has received a live vaccine within 28 days of the planned start of study treatment. * Evidence of interstitial lung disease or active, noninfectious pneumonitis. * Participants who are known to be HIV-positive with some protocol exceptions.
References
Publications (0)
Data not yet available