Phase 2, Open-Label, Multicenter Study of INCAGN01876 in Combination With Immunotherapy in Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

  • STATUS
    Recruiting
  • End date
    Dec 18, 2024
  • participants needed
    47
  • sponsor
    Incyte Biosciences International Sàrl
Updated on 28 October 2022
measurable disease
carcinoma

Summary

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).

Description

The purpose of this study is to determine the safety, tolerability, efficacy, PK and pharmacodynamics of INCAGN01876 when given in combination with retifanlimab in participants with GITR expression in recurrent or metastatic HNSCC who have progressed on or after prior systemic therapy including anti-PD-(L)1 therapy. The study will consist of 2 parts: a safety lead-in part (Part 1) followed by a dose expansion part (Part 2)

Details
Condition Recurrent Cancer, Metastatic Cancer, Advanced Malignancies, Head and Neck Squamous Cell Carcinoma
Treatment INCAGN01876, Retifanlimab
Clinical Study IdentifierNCT05359692
SponsorIncyte Biosciences International Sàrl
Last Modified on28 October 2022

Eligibility

Yes No Not Sure

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
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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