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OpenTrials
Completed

NCT Number: 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.

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Retifanlimab

Drug

INCMGA00012 administered intravenously on Day 1 of each 28-day cycle for up to 26 cycles.

Other names: INCMGA00012

Epacadostat

Drug

epacadostat will be administered orally BID.

Pemigatinib

Drug

pemigatinib will be administered orally QD.

INCAGN02385

Drug

INCAGN2385 will be administered every 2 weeks

INCAGN02390

Drug

INCAGN2390 will be administered every 2 weeks

Primary outcomes

  1. Group A - Objective Response Rate

    Time frame: up to 2.5 years

    Defined as the proportion of participants having a CR or PR according to RECIST v1.1, as assessed by Independent Central Review committee

Secondary outcomes

  1. Group A -Duration of Response

    Time frame: up to 2.5 years

    Defined as the time from the first documented objective response (CR or PR) according to RECIST v1.1 (as determined by ICR) until disease progression or death due to any cause.

  2. Group A - Disease Control Rate

    Time frame: up to 2.5 years

    Defined as the proportion of participants with CR, PR, or SD (as determined by ICR) as best response.

  3. Group A - Overall Survival

    Time frame: up to 3.5 years

    Defined as the time from the first dose of study treatment until death due to any cause.

  4. Group A - Progression Free Survival

    Time frame: up to 3.5 years

    Defined as the time from the first dose of study treatment until disease progression (as determined by ICR) or death due to any cause.

  5. Group B -Duration of Response

    Time frame: up to 2.5 years

    Defined as the time from the first documented objective response (CR or PR) according to RECIST v1.1 (as determined by ICR) until disease progression or death due to any cause.

  6. Group B - Disease Control Rate

    Time frame: up to 2.5 years

    Defined as the proportion of participants with CR, PR, or SD (as determined by ICR) as best response.

  7. Group B - Overall Survival

    Time frame: up to 3.5 years

    Defined as the time from the first dose of study treatment until death due to any cause.

  8. Groups B - Objective Response Rate

    Time frame: up to 2 years

    Defined as the proportion of participants having a CR or PR according to RECIST v1.1, as assessed by Independent Central Review committee

  9. Group B - Progression Free Survival

    Time frame: up to 3.5 years

    Defined as the time from the first dose of study treatment until disease progression (as determined by ICR) or death due to any cause.

  10. Groups C, D, E and F - Objective Response Rate

    Time frame: up to 2 years

    Defined as the proportion of participants having a CR or PR according to RECIST v1.1, as assessed by Independent Central Review committee

  11. Number of Treatment-Related Adverse Events

    Time frame: up to 4 years

    Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.

Sponsors and collaborators

Lead sponsor

Incyte Corporation

Industry

Collaborators

  • European Network of Gynaecological Oncological Trial Groups (ENGOT)
  • GOG Foundation

Registry information

Official study title

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)

Acronym: POD1UM-204

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jul 9, 2020
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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