Head and Neck Cancer, Advanced/Metastatic

INCAGN01876 in Combination With Immunotherapy in Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Incyte Study ID:
INCAGN 1876-204
CT.gov ID:
NCT05359692
Eudra ID:
N/A
EU CT Number:
N/A
Sponsor:
Incyte Biosciences International Sàrl
Collaborator:
N/A
Study Contact Information:
1.855.463.3463 or [email protected]
Other
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Clinical Study Purpose

The purpose of this study is to determine the safety, tolerability, efficacy, PK and pharmacodynamics of INCAGN01876 when given in combination with retifanlimab. The study will consist of 2 parts: a safety lead-in part (Part 1) followed by a dose expansion part (Part 2).

Clinical Study Summary

MEDICAL CONDITION(S)
  • Head and Neck Cancer
  • Advanced/Metastatic
    • PRODUCT
    N/A
    COLLABORATORS
    N/A
    DATE
    Mar 2023 - Jan 2025
    TYPE
    Interventional
    PHASE
    Phase 2
    SEX
    Female & Male
    AGE
    18 - 99 Years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Clinical Study Locations

    Name
    Contact Us
    Name
    JOHN THEURER CANCER CENTER, HACKENSACK UNIVERSITY MEDICAL CENTER
    HACKENSACK, NJ, US, 07601
    Name
    UNIVERSITY OF CALIFORNIA SAN DIEGO MEDICAL CENTER, MOORES CANCER CENTER
    LA JOLLA, CA, US, 92093
    Name
    MOUNT SINAI PRIME
    NEW YORK, NY, US, 10029
    Name
    UAB MEDICINE-THE KIRKLIN CLINIC
    BIRMINGHAM, AL, US, 35233
    Name
    DANA FARBER CANCER INSTITUTE
    BOSTON, MA, US, 02215
    Name
    KARMANOS CANCER INSTITUTE
    DETROIT, MI, US, 48201
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    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Histologically or cytologically confirmed recurrent or metastatic HNSCC (oral cavity, oropharynx, hypopharynx, or larynx), that is not amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy). Participants with squamous cell carcinomas of the nasopharynx, salivary gland, or nonsquamous cell histology are excluded.
    • Documented progression on or after PD-(L)1 inhibitor alone or in combination with platinum-based chemotherapy for recurrent or metastatic HNSCC. Exception: Treatment Group B (Part 2, expansion): PD-(L)1-naïve.

    Exclusion Criteria

    • Have received chemotherapy, targeted small molecule therapy or curative radiation within 21 days of first dose of study drug; prior mAB for anticancer therapy other within 28 days of first dose of study drug; or investigational study drugs or devices within 28 days or five half-lives prior to enrollment unless approved by medical monitor.
    • Prior treatment with any TNF Super Family agonist therapy.
    Requirements information
    Inclusion Criteria
    • Histologically or cytologically confirmed recurrent or metastatic HNSCC (oral cavity, oropharynx, hypopharynx, or larynx), that is not amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy). Participants with squamous cell carcinomas of the nasopharynx, salivary gland, or nonsquamous cell histology are excluded.
    • Documented progression on or after PD-(L)1 inhibitor alone or in combination with platinum-based chemotherapy for recurrent or metastatic HNSCC. Exception: Treatment Group B (Part 2, expansion): PD-(L)1-naïve.
    • ECOG performance status of 0 to 1.
    • Measurable disease based on RECIST v1.1.
    • Mandatory pre-treatment and on-treatment tumor biopsies.
    • GITR-positive tumor confirmed by central laboratory before study treatment start.
    • Willingness to avoid pregnancy or fathering children.
    Exclusion Criteria
    • Have received chemotherapy, targeted small molecule therapy or curative radiation within 21 days of first dose of study drug; prior mAB for anticancer therapy other within 28 days of first dose of study drug; or investigational study drugs or devices within 28 days or five half-lives prior to enrollment unless approved by medical monitor.
    • Prior treatment with any TNF Super Family agonist therapy.
    • Have not recovered to ≤ Grade 1 from toxic effects of prior therapy.
    • Laboratory and medical history parameters not within the Protocol-defined range before the first administration of study treatment.
    • Known active HBV or HCV, or Known to be seropositive for HIV.
    • Have an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs).
    • Have an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs).
    • Known active infections requiring systemic treatment.

    Protocol Summary

    Incyte Study ID:
    INCAGN 1876-204
    Primary Purpose:
    Treatment
    Allocation:
    Non-randomized
    Study Design:
    Single Group Assignment
    Masking:
    None (Open Label)
    Interventions:
    N/A
    Enrollment:
    0
    Primary Outcome
    Open

    Part 1: Participants With Treatment-Emergent Adverse Events (TEAEs)

    Timeframe: Screening through 90 days after end of treatment, up to 24 months

    Objective response rate (ORR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

    Timeframe: Assessed every 8 weeks for 12 months, thereafter every 12 weeks up to the end of treatment, up to 24 months.

    Secondary Outcome
    Open

    Duration of response (DOR) based on RECIST v1.1 and mRECIST

    Timeframe: Assessed every 8 weeks for 12 months, then every 12 weeks, up to 24 months.

    Disease control rate (DCR) based on RECIST v1.1 and mRECIST

    Timeframe: Assessed every 8 weeks for 12 months, then every 12 weeks, up to 24 months.

    Progression-free survival (PFS) based on RECIST v1.1 and mRECIST

    Timeframe: Assessed every 8 weeks for 12 months, then every 12 weeks, up to 24 months.

    Part 2: Participants With Treatment-Emergent Adverse Events (TEAEs)

    Timeframe: Screening through 90 days after end of treatment, up to 24 months