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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.

Sponsored by Incyte Corporation

About this trial

Last updated 2 years ago

Study ID

INCMGA 0012-204

Status

Recruiting

Type

Interventional

Phase

Phase 2

Placebo

No

Accepting

18-75 Years
18+ Years
Female
Female

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Started 4 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

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.

No

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.

Locations

Location

Status

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Withdrawn