Study of Magrolimab Combination Therapy in Participants With Head and Neck Squamous Cell Carcinoma
Status:
Recruiting
Trial end date:
2023-09-01
Target enrollment:
Participant gender:
Summary
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).