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. (POD1UM-204)

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Incyte

Status and phase

Enrolling
Phase 2

Conditions

Endometrial Cancer

Treatments

Drug: INCAGN02390
Drug: pemigatinib
Drug: epacadostat
Drug: INCAGN02385
Drug: retifanlimab

Study type

Interventional

Funder types

Other
NETWORK
Industry

Identifiers

NCT04463771
INCMGA 0012-204

Details and patient eligibility

About

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.

Enrollment

300 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

300 participants in 6 patient groups

Group A - retifanlimab
Experimental group
Description:
Select participants naïve to checkpoint inhibitors will be administered retifanlimab intravenously
Treatment:
Drug: retifanlimab
Group B - retifanlimab
Experimental group
Description:
Select participants naïve to checkpoint inhibitors will be administered retifanlimab intravenously
Treatment:
Drug: retifanlimab
Group C - retifanlimab + epacadostat
Experimental group
Description:
Select participants who are allowed on prior checkpoint inhibitors will be administered retifanlimab intravenously in combination with oral epacadostat (IDO1 inhibitor)
Treatment:
Drug: retifanlimab
Drug: epacadostat
Group D - retifanlimab + pemigatinib
Experimental group
Description:
Select participants who are allowed on prior checkpoint inhibitors will be administered retifanlimab intravenously in combination with oral pemigatininb (FGFR 1,2,3 inhibitor)
Treatment:
Drug: retifanlimab
Drug: pemigatinib
Group E - retifanlimab + epacadostat
Experimental group
Description:
Select participants naïve to checkpoint inhibitors will be administered retifanlimab intravenously in combination with oral epacadostat
Treatment:
Drug: retifanlimab
Drug: epacadostat
Group F - retifanlimab + INCAGN02385 and INCAGN02390
Experimental group
Description:
Select participants who are allowed on prior checkpoint inhibitors will be administered retifanlimab in combination with INCAGN02385 and INCAGN02390 intravenously
Treatment:
Drug: INCAGN02385
Drug: INCAGN02390

Trial contacts and locations

67

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Central trial contact

Incyte Corporation Call Center (ex-US); Incyte Corporation Call Center (US)

Data sourced from clinicaltrials.gov

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