Spots Global Cancer Trial Database for INCAGN01876 in Combination With Immunotherapy in Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
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Trial Identification
Brief Title: INCAGN01876 in Combination With Immunotherapy in Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Official Title: Phase 2, Open-Label, Multicenter Study of INCAGN01876 in Combination With Immunotherapy in Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Study ID: NCT05359692
Study Description
Brief 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).
Detailed 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)
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Contact Details
Name: Nawel Bourayou, MD
Affiliation: Incyte Corporation
Role: STUDY_DIRECTOR
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