Skin Cancer

Study of Combination Therapy With INCMGA00012 (Anti–PD-1), INCAGN02385 (Anti–LAG-3), and INCAGN02390 (Anti–TIM-3) in Participants With Select Advanced Malignancies

Incyte Study ID:
INCAGN 2385-201
CT.gov ID:
NCT04370704
Eudra ID:
2021-005775-39
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
1.855.463.3463 or [email protected]
Recruitment Complete
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Clinical Study Purpose

The study will determine Recommended Phase 2 Dose for all study drugs, based on the safety and tolerability of the following combinations: INCAGN02385 + INCAGN02390 and INCAGN02385 + INCAGN02390 + INCMGA00012.

Clinical Study Summary

MEDICAL CONDITION(S)
  • Skin Cancer
    • PRODUCT
  • Drug: INCAGN02385
  • Drug: INCAGN02390
  • Drug: INCMGA00012.
    • COLLABORATORS
    N/A
    DATE
    Jul 2020 - Aug 2025
    TYPE
    Interventional
    PHASE
    Phase 1/Phase 2
    SEX
    Female & Male
    AGE
    18+ years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Clinical Study Locations

    Name
    Contact Us
    Name
    CAROLINA BIO ONCOLOGY
    HUNTERSVILLE, NC, US, 28078
    Name
    THE ANGELES CLINIC AND RESEARCH INSTITUTE
    LOS ANGELES, CA, US, 90025
    Name
    JOHN THEURER CANCER CENTER, HACKENSACK UNIVERSITY MEDICAL CENTER
    HACKENSACK, NJ, US, 07601
    Name
    NYU LANGONE LAURA AND ISAAC PERLMUTTER CANCER CENTER
    NEW YORK, NY, US, 10016
    Name
    UNIVERSITY OF IOWA
    IOWA CITY, IA, US, 52242
    Name
    H LEE MOFFITT CANCER CENTER AND RESEARCH
    TAMPA, FL, US, 33612

    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Phase 1 Parts 1-4): Participants with locally advanced or metastatic solid tumors (locally advanced disease must not be amenable to resection with curative intent) that have failed available therapies, including anti-PD-(L)1 therapy if applicable, that are known to confer clinical benefit, or who are intolerant to, or ineligible for standard treatment. Prior anti-PD-(L)1 therapy should not have been discontinued because of intolerance.
    • Phase 2, Cohort A:

    Exclusion Criteria

    • Laboratory and medical history parameters outside the protocol-defined range.
    • Known hypersensitivity or severe reaction to any component of the study drugs or formulation components ) within 14 days before study Day 1.

    Protocol Summary

    Incyte Study ID:
    INCAGN 2385-201
    Primary Purpose:
    Treatment
    Allocation:
    Non-randomized
    Study Design:
    Parallel Assignment
    Masking:
    None (Open Label)
    Interventions:
    Drug
    Enrollment:
    61
    Primary Outcome
    Open

    Phases 1 & 2: Participants with treatment-emergent adverse events (TEAEs)

    Timeframe: 28 days after end of study approximately 24 months

    Phase 2 Cohort A and B: Objective Response Rate (ORR)

    Timeframe: Every 8 weeks for first 12 months, and every 12 weeks until disease progression; approximately 24 months

    Phase 2 Cohort A and B: Duration of Response (DOR)

    Timeframe: Every 8 weeks for first 12 months, and every 12 weeks until disease progression; approximately 24 months

    Phase 2 Cohort A and B: Disease Control Rate (DCR)

    Timeframe: Every 8 weeks for first 12 months, and every 12 weeks until disease progression; approximately 24 months

    Phase 2 Cohort A and B: Progression-free Survival (PFS)

    Timeframe: Every 8 weeks for first 12 months, and every 12 weeks until disease progression; approximately 24 months

    Secondary Outcome
    Open

    Phase 1 : Objective Response Rate

    Timeframe: Every 8 weeks for first 12 months, and every 12 weeks until disease progression; aprroximately 24 months

    Phase 1 : Progression Free Survival

    Timeframe: Every 8 weeks for first 12 months, and every 12 weeks until disease progression; aprroximately 24 months

    Phase 1: Disease Control Rate (DCR)

    Timeframe: Every 8 weeks for first 12 months, and every 12 weeks until disease progression; approximately 24 months