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Clinical Trial 20872

Cancer Type: Gynecological Tumor
Study Type: Treatment
NCT#: NCT04463771

Phase: Phase II
Prinicipal Investigator: Shahzad, Mian

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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 (); INCB024360 (Epacadostat); INCMGA00012 (); Pemigatinib ()

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

  • 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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