Clinical Trial 20872

• Overview

  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)

  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.

  Objective:

  Primary: To evaluate antitumor activity of INCMGA00012 in Group A. Secondary: To further evaluate clinical efficacy of INCMGA00012 monotherapy and evaluate clinical activity in the combinations. To evaluate the safety and tolerability of INCMGA00012 as monotherapy and in combination.

• Treatments

  Therapies:

  Immunotherapy

  Medications:

  Epacadostat (); INCAGN02385 (); INCAGN02390 (); INCB024360 (Epacadostat); INCMGA00012 (); Pemigatinib ()

• Inclusion Criteria

  > Inclusion Criteria:
  • Ability to comprehend and willingness to sign a written ICF for the study. 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. Note for Group E only: No more than 1 systemic regimen for advanced or metastatic disease is allowed. For all groups neoadjuvent chemotherapy in an early stage disease is allowable. Prior hormonal therapy is allowable in any disease setting.
  • 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 using Promega OncoMate MSI Dx assay
  • Group B only: Tumor tissue tested as deficient MMR using MMR assay or known to have ultra-mutated POLE tumor per locally available result.
  • Group D only: Tumor tissue tested locally or centrally based on CLIA-certified (or similar certification) laboratory assays as having an FGFR mutation or alteration characterized in protocol.
  • Group E only: Tumor tissue centrally tested as PD-L1 positive using Ventana SP263 assay (determined based on PD-L1 staining of both tumor cells (TC) and immune cells (IC and ICP) and MSS using Promega OncoMate MSI Dx assay.
  • 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

  > 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 > Groups C and D (combinations): limiting immune-related toxicity during prior checkpoint inhibitor 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.

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