Genitourinary & Gynecologic Cancer

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.

Incyte Study ID:
INCMGA 0012-204
CT.gov ID:
NCT04463771
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
Gynecologic Oncology Group (GOG),European Network of Gynaecological Oncological Trial Groups (ENGOT)
Study Contact Information:
1.855.463.3463 or [email protected]
Recruitment Complete
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Clinical Study 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.

Clinical Study Summary

MEDICAL CONDITION(S)
  • Genitourinary & Gynecologic Cancer
    • PRODUCT
  • Drug: retifanlimab
  • Drug: epacadostat
  • Drug: pemigatinib
  • Drug: INCAGN02385
  • Drug: INCAGN02390
    • COLLABORATORS
    Gynecologic Oncology Group (GOG),European Network of Gynaecological Oncological Trial Groups (ENGOT)
    DATE
    Jan 2021 - Apr 2025
    TYPE
    Interventional
    PHASE
    Phase 2
    SEX
    Female only
    AGE
    18+ years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Clinical Study Locations

    Name
    Contact Us
    Name
    WILLAMETTE VALLEY CANCER INSTITUTE
    EUGENE, OR, US, 97401-8122
    Name
    ARIZONA ONCOLOGY ASSOCIATES
    TUCSON, AZ, US, 85711
    Name
    TEXAS ONCOLOGY SAN ANTONIO
    SAN ANTONIO, TX, US, 78240
    Name
    TEXAS ONCOLOGY-TYLER
    SIOUX FALLS, SD, US, 57104
    Name
    TEXAS ONCOLOGY-AUSTIN CENTER
    AUSTIN, TX, US, 78731
    Name
    MINNESOTA ONCOLOGY-MAPLEWOOD
    COON RAPIDS, MN, US, 55433

    Key Inclusion and Exclusion Criteria

    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

    Exclusion Criteria

    • Group A, B and E only: Histologically confirmed diagnosis of carcinosarcoma of the uterus.
    • Histologically confirmed diagnosis of sarcoma of the uterus.

    Protocol Summary

    Incyte Study ID:
    INCMGA 0012-204
    Primary Purpose:
    Treatment
    Allocation:
    Non-randomized
    Study Design:
    Parallel Assignment
    Masking:
    None (Open Label)
    Interventions:
    Drug
    Enrollment:
    206
    Primary Outcome
    Open

    Group A - Objective Response Rate

    Timeframe: up to 2.5 years

    Secondary Outcome
    Open

    Group A -Duration of Response

    Timeframe: up to 2.5 years

    Group A - Disease Control Rate

    Timeframe: up to 2.5 years

    Group A - Overall Survival

    Timeframe: up to 3.5 years

    Group A - Progression Free Survival

    Timeframe: up to 3.5 years

    Group B -Duration of Response

    Timeframe: up to 2.5 years

    Group B - Disease Control Rate

    Timeframe: up to 2.5 years

    Group B - Overall Survival

    Timeframe: up to 3.5 years

    Groups B - Objective Response Rate

    Timeframe: up to 2 years

    Group B - Progression Free Survival

    Timeframe: up to 3.5 years

    Groups C, D, E and F - Objective Response Rate

    Timeframe: up to 2 years

    Number of Treatment-Related Adverse Events

    Timeframe: up to 4 years