INCAGN01876 in Combination With Immunotherapy in Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Launched by INCYTE BIOSCIENCES INTERNATIONAL SÀRL · May 3, 2022
Trial Information
Current as of June 18, 2025
Withdrawn
Keywords
ClinConnect Summary
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)
Gender
ALL
Eligibility 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.
- • 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.
About Incyte Biosciences International Sàrl
Incyte Biosciences International Sàrl is a global biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative therapies for patients with serious diseases, particularly in oncology and hematology. With a strong focus on precision medicine, Incyte leverages cutting-edge research and advanced technologies to address unmet medical needs. The company is committed to advancing clinical trials that evaluate novel treatments, fostering collaboration with healthcare professionals and organizations to enhance patient outcomes and drive scientific progress in the field.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Chicago, Illinois, United States
Boston, Massachusetts, United States
Pittsburgh, Pennsylvania, United States
Palo Alto, California, United States
New York, New York, United States
Houston, Texas, United States
Westwood, Kansas, United States
Louisville, Kentucky, United States
Detroit, Michigan, United States
Salt Lake City, Utah, United States
Baltimore, Maryland, United States
Hackensack, New Jersey, United States
Cincinnati, Ohio, United States
La Jolla, California, United States
Portland, Oregon, United States
Birmingham, Alabama, United States
New York, New York, United States
Richmond, Virginia, United States
Lakewood, California, United States
Whittier, California, United States
Baltimore, Maryland, United States
Patients applied
Trial Officials
Nawel Bourayou, MD
Study Director
Incyte Corporation
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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