Sponsor: Gilead Sciences, Inc.
Sponsor Study ID: GS-US-548-5916
Study Title: A Phase 2 Study of Magrolimab Combination Therapy in Patients With Head and Neck Squamous Cell Carcinoma
CTO #: 103754
NCT Number: NCT04854499
Phase: II
Protocol Type: Treatment
Age Group: Adults
Disease Sites: Larynx; Lip, Oral Cavity and Pharynx
Study Objectives: The study consists of Safety Run-in and Phase 2 Cohorts. The primary objectives of the safety run-in cohorts of this study are to evaluate the safety, tolerability, and recommended Phase 2 dose (RP2D) of magrolimab in combination with pembrolizumab + 5-fluorouracil (5-FU) + platinum chemotherapy, and docetaxel in combination with magrolimab in participants with head and neck squamous cell carcinoma (HNSCC). Phase 2 Cohorts 1: To evaluate the progression-free survival (PFS) with magrolimab in combination with pembrolizumab + 5-FU + platinum versus pembrolizumab + 5-FU + platinum as assessed by independent central review. Phase 2 Cohorts 2 and 3: To evaluate the efficacy of magrolimab in combination with pembrolizumab and magrolimab in combination with docetaxel as determined by the investigator-assessed objective response rate (ORR).