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

Withdrawn before enrolling · Phase 2

Conditions studied: Metastatic Head and Neck Squamous Cell Carcinoma, Advanced Malignancies, Recurrent Head and Neck Squamous Cell Carcinoma

In brief

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).

Key facts

Study ID

NCT05359692

Run by

Incyte Biosciences International Sàrl

People needed

0

Starts

2023-03-01

Expected to finish

2025-01-11

Last updated by the study team

2023-09-15

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Uab Medicine-the Kirklin Clinic — Birmingham, Alabama, United States
• University of California San Diego Medical Center, Moores Cancer Center — La Jolla, California, United States
• Stanford University — Palo Alto, California, United States
• Toi Clinical Research — Whittier, California, United States
• University of Chicago — Chicago, Illinois, United States
• University of Kansas Cancer Center — Westwood, Kansas, United States
• Norton Cancer Institute — Louisville, Kentucky, United States
• University of Maryland-Greenebaum Cancer Center — Baltimore, Maryland, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• John Theurer Cancer Center, Hackensack University Medical Center — Hackensack, New Jersey, United States
• Mount Sinai Prime — New York, New York, United States
• University of Cincinnati Cancer Institute — Cincinnati, Ohio, United States
• Providence Portland Med. Ctr — Portland, Oregon, United States
• Md Anderson Cancer Center — Houston, Texas, United States
• University of Utah — Salt Lake City, Utah, United States
• The Adult Outpatient Pavilion At Vcu — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.