Head and Neck Cancer

Study of Retinfanlimab in Combination with INCAGN02385 and INCAGN02390 as First-Line Treatment in Participants With PD-L1-Positive (CPS ≥ 1) Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck

Incyte Study ID:
INCAGN 2385-203
CT.gov ID:
NCT05287113
Eudra ID:
N/A
Sponsor:
Incyte Biosciences International Sàrl
Collaborator:
N/A
Study Contact Information:
1.855.463.3463 or [email protected]
Recruitment Complete
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Clinical Study Purpose

The purpose of this study is to evaluate the safety and efficacy of the combination of retifanlimab plus INCAGN02385 and retifanlimab plus INCAGN02385 and INCAGN02390 compared with retifanlimab alone as first-line treatment in PD-L1–positive and systemic therapy–naive recurrent/metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN).

Clinical Study Summary

MEDICAL CONDITION(S)
  • Head and Neck Cancer
    • PRODUCT
  • Drug: Retifanlimab
  • Drug: INCAGN02385
  • Drug: INCAGN02390
  • Drug: Placebo
    • COLLABORATORS
    N/A
    DATE
    Nov 2022 - Mar 2025
    TYPE
    Interventional
    PHASE
    Phase 2
    SEX
    Female & Male
    AGE
    18 - 99 Years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Clinical Study Locations

    Name
    Contact Us
    Name
    GRAND HOSPITAL DE CHARLEROI
    CHARLEROI, Belgium, 06000
    Name
    JESSA ZIEKENHUIS
    HASSELT, Belgium, 03500
    Name
    GZA SINT AUGUSTINUS
    WILRIJK, Belgium, 02610
    Name
    MCGILL UNIVERSITY HEALTH CENTRE/GLEN SITE/CEDARS CANCER CENTRE
    MONTREAL, QC, Canada, H2X 3E4
    Name
    MCGILL UNIVERSITY JEWISH GENERAL HOSPITAL
    MONTREAL, QC, Canada, H3T 1E2
    Name
    CHUM HOSPITAL NOTRE DAME
    MONTREAL, QC, Canada, H2X3E4

    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Histologically or cytologically confirmed R/M SCCHN that is not amenable to therapy with curative intent. Participants who refuse potentially curative salvage surgery for recurrent disease are ineligible.
    • Eligible primary tumor locations are oropharynx, oral cavity, hypopharynx, and

    Exclusion Criteria

    • Progressive or recurrent disease within 6 months of the last dose of systemic treatment
    • for locally advanced SCCHN.

    Protocol Summary

    Incyte Study ID:
    INCAGN 2385-203
    Primary Purpose:
    Treatment
    Allocation:
    Randomized
    Study Design:
    Parallel Assignment
    Masking:
    Triple (Participant, Care Provider, Investigator)
    Interventions:
    Drug
    Enrollment:
    176
    Primary Outcome
    Open

    Progression Free Survival (PFS)

    Timeframe: Up to 24 months

    Secondary Outcome
    Open

    Objective Response Rate (ORR)

    Timeframe: Up to 24 months

    Duration of Response (DOR)

    Timeframe: Up to 24 months

    Disease Control Rate (DCR)

    Timeframe: Up to 24 months

    Overall Survival (OS)

    Timeframe: Up to 36 months

    Participants with treatment-emergent adverse events (TEAE)

    Timeframe: Up to 24 months