Last updated: October 26, 2023
Sponsor: Incyte Corporation
Overall Status: Active - Recruiting
Phase
2
Condition
Endometrial Cancer
Uterine Cancer
Treatment
INCAGN02390
pemigatinib
Retifanlimab
Clinical Study ID
NCT04463771
INCMGA 0012-204
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
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
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.
Study Design
Total Participants: 300
Treatment Group(s): 5
Primary Treatment: INCAGN02390
Phase: 2
Study Start date:
January 26, 2021
Estimated Completion Date:
May 31, 2026
Study Description
Connect with a study center
Beijing Cancer Hospital
Beijing, 100142
ChinaActive - Recruiting
Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori
Meldola, 47014
ItalyActive - Recruiting
Fondazione IRCCS Istituto Nazionale Dei Tumori
Milano, 20133
ItalyActive - Recruiting
Washington University
Saint Louis, Missouri 63110
United StatesActive - Recruiting
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