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Brief Title: Ribociclib and Spartalizumab in R/M HNSCC
Official Title: Ribociclib and Spartalizumab for Head and Neck Squamous Cell Carcinoma, a Phase I Study With Expansion Cohort (RISE-HN)
Study ID: NCT04213404
Brief Summary: This study examines the safety and efficacy of ribociclib (CDK 4/6 inhibitors) and spartalizumab (anti-PD1) in patients with recurrent and/or metastatic head and neck squamous cell carcinoma (R/M HNSCC).
Detailed Description: The study is a phase I study testing ribociclib (with dose titration plan) and spartalizumab (fixed dose) for R/M HNSCC. The primary endpoints are safety and objective response rate.
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
National Taiwan University Hospital, Taipei, , Taiwan
Name: Hsiang-Fong Kao, MD
Affiliation: National Taiwan University Hospital
Role: PRINCIPAL_INVESTIGATOR