Trial Identifiers
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Scientific Title
A Phase 2 Study of Magrolimab Combination Therapy in Patients With Head and Neck Squamous Cell Carcinoma
Commercial Sponsor
Gilead Sciences, Inc.
Summary
This study consists of a Safety Run-in and Phase 2 Cohorts. The primary objective of the safety run-in cohorts 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 Safety Run-in Cohort 1, participants will receive magrolimab + pembrolizumab + 5-FU + platinum chemotherapy, all administered intravenously. In Safety Run-in Cohort 2, participants will receive magrolimab + docetaxel, both administered intravenously. In the Pre-expansion Safety Run-in Cohort, participants will receive magrolimab + pembrolizumab, both administered intravenously. The objective of the Phase 2 cohorts are to evaluate the effectiveness of these treatments. In the Phase 2 Cohort 1 (Arm A), participants will receive magrolimab + pembrolizumab + 5-FU + platinum chemotherapy, all administered intravenously. In the Phase 2 Cohort 1 (Arm B), participants will receive pembrolizumab + 5-FU + platinum chemotherapy. In the Phase 2 Cohort 1 (Arm C), participants will receive magrolimab + zimberelimab + 5-FU + platinum chemotherapy. In the Phase 2 Cohort 2, participants will receive magrolimab + pembrolizumab. In the Phase 2 Cohort 3, participants will receive magrolimab + docetaxel.