Clinical Trials /

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.

NCT04463771

Description:

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.

Related Conditions:
  • Endometrial Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: 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.
  • Official 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)

Clinical Trial IDs

  • ORG STUDY ID: INCMGA 0012-204
  • NCT ID: NCT04463771

Conditions

  • Endometrial Cancer

Interventions

DrugSynonymsArms
retifanlimabINCMGA00012Group A - retifanlimab
epacadostatGroup C - retifanlimab + epacadostat
pemigatinibGroup D - retifanlimab + pemigatinib

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Group A - retifanlimabExperimentalSelect participants will be administered retifanlimab intravenously
  • retifanlimab
Group B - retifanlimabExperimentalSelect participants will be administered retifanlimab intravenously
  • retifanlimab
Group C - retifanlimab + epacadostatExperimentalParticipants will be administered retifanlimab intravenously in combination with oral epacadostat (IDO1 inhibitor)
  • retifanlimab
  • epacadostat
Group D - retifanlimab + pemigatinibExperimentalSelect participants will be administered retifanlimab intravenously in combination with oral pemigatininb (FGFR 1,2,3 inhibitor)
  • retifanlimab
  • pemigatinib

Eligibility 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.

          -  Groups A and B: 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.

          -  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 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 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Group A - Objective Response Rate
Time Frame:up to 2.5 years
Safety Issue:
Description:Defined as the proportion of participants having a CR or PR according to RECIST v1.1, as assessed by Independent Central Review committee

Secondary Outcome Measures

Measure:Group A -Duration of Response
Time Frame:up to 2.5 years
Safety Issue:
Description: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.
Measure:Group A - Disease Control Rate
Time Frame:up to 2.5 years
Safety Issue:
Description:Defined as the proportion of participants with CR, PR, or SD (as determined by ICR) as best response.
Measure:Group A - Overall Survival
Time Frame:up to 3.5 years
Safety Issue:
Description:Defined as the time from the first dose of study treatment until death due to any cause.
Measure:Groups B, C, and D - Objective Response Rate
Time Frame:up to 2 years
Safety Issue:
Description:Defined as the proportion of participants having a CR or PR according to RECIST v1.1, as assessed by Independent Central Review committee
Measure:Number of Treatment-Related Adverse Events
Time Frame:up to 4 years
Safety Issue:
Description:Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Incyte Corporation

Trial Keywords

  • Endometrial Carcinoma
  • Endometrium Cancer
  • Neoplasms Endometrial
  • Advanced
  • Metastatic
  • PD-1
  • PD-L1
  • retifanlimab
  • INCMGA0012
  • PODIUM

Last Updated

July 6, 2020