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) (POD1UM-204)

  • STATUS
    Recruiting
  • End date
    Jun 22, 2025
  • participants needed
    300
  • sponsor
    Incyte Corporation
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Updated on 25 October 2022
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cancer
platinum-based chemotherapy
metastatic endometrial cancer

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.

Details
Condition Endometrial Cancer
Treatment Epacadostat, pemigatinib, INCAGN02385, INCAGN02390, Retifanlimab
Clinical Study IdentifierNCT04463771
SponsorIncyte Corporation
Last Modified on25 October 2022

Eligibility

 Yes No Not Sure

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
Must have at least 1 measurable tumor lesion per RECIST v1.1
Group F: Radiological evidence of disease progression on or after prior PD (L)1 therapy and Tumor tissue tested as MSI-H
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
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
Groups C, D and F (combinations): limiting immune-related toxicity during prior checkpoint inhibitor therapy
Receiving chronic systemic steroids (> 10 mg/day of prednisone or equivalent)
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
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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