INCAGN01876 in Combination With Immunotherapy in Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Reason given: Business decision; no safety concerns
Key facts
- Where
- Baltimore, Birmingham, Boston, Chicago, Cincinnati, Detroit, Hackensack, Houston, La Jolla, Louisville, New York, Palo Alto, Portland, Richmond, Salt Lake City, Westwood, and Whittier, United StatesSee the 17 sites
- Phase
- Phase 2
Where in United States
- University of Maryland/Greenebaum Cancer CenterBaltimore, United StatesNo longer taking part
- Uab Medicine-the Kirklin ClinicBirmingham, United StatesNo longer taking part
- Dana-Farber Cancer InstituteBoston, United StatesNo longer taking part
- University of ChicagoChicago, United StatesNo longer taking part
- University of Cincinnati Cancer InstituteCincinnati, United StatesNo longer taking part
- Karmanos Cancer InstituteDetroit, United StatesNo longer taking part
- John Theurer Cancer Center, Hackensack University Medical CenterHackensack, United StatesNo longer taking part
- MD Anderson Cancer CenterHouston, United StatesNo longer taking part
- University of California San Diego Medical Center, Moores Cancer CenterLa Jolla, United StatesNo longer taking part
- Norton Cancer InstituteLouisville, United StatesNo longer taking part
- Mount Sinai - PRIMENew York, United StatesNo longer taking part
- Stanford UniversityPalo Alto, United StatesNo longer taking part
- Providence Portland Med. CtrPortland, United StatesNo longer taking part
- The Adult Outpatient Pavilion At VcuRichmond, United StatesNo longer taking part
- University of UtahSalt Lake City, United StatesNo longer taking part
- University of Kansas Cancer CenterWestwood, United StatesNo longer taking part
- TOI Clinical researchWhittier, United StatesNo longer taking part
Trial details
- Who runs it
- Incyte Biosciences International Sàrl
- Trial code
- NCT05359692
- Record updated
- 15 September 2023
- Original description
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).Read full original descriptionShow less
Phase 2, Open-Label, Multicenter Study of INCAGN01876 in Combination With Immunotherapy in Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
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).
Inclusion: 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: 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; 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; 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.