Study of Magrolimab Combination Therapy in Participants With Head and Neck Squamous Cell Carcinoma

• Status: Recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Carboplatin; Docetaxel; Magrolimab; Pembrolizumab

Criteria

Key Inclusion Criteria:

• Histologically or cytologically confirmed metastatic or locally recurrent HNSCC that is considered incurable by local therapies

Safety Run-in Cohort 1 and Phase 2 Cohorts 1

• HNSCC per protocol specified inclusion criteria regardless of PD-L1 status

• HNSCC per protocol specified inclusion criterion with a PD-L1 CPS ≥ 1

Safety Run-in Cohort 2 and Phase 2 Cohort 3

• Histologically or cytologically confirmed locally advanced/mHNSCC regardless of PD-L1 status with at least 1 and no more than 2 lines of prior systemic anticancer therapy in the locally advanced/metastatic setting

Key Exclusion Criteria:

• Active central nervous system (CNS) disease (individuals with asymptomatic and stable, treated CNS lesions who have been off corticosteroids, radiation, or other CNS-directed therapy for at least 4 weeks are not considered active)

• History of (noninfectious) pneumonitis that required steroids or current pneumonitis

Safety Run-in Cohort 1, Pre-expansion Safety Run-in Cohort for Magrolimab + Pembrolizumab (if Applicable), and Phase 2 Cohorts 1 and 2

• Prior treatment with any of the following:

• Anti-programmed cell death protein 1 or anti-PD-L1 checkpoint inhibitors

• Anti-cytotoxic T-lymphocyte-associated protein 4 checkpoint inhibitors

• 5-FU and platinum-based chemotherapy (Safety Run-in Cohort 1 and Phase 2 Cohorts 1 only)

Safety Run-in Cohort 2 and Phase 2 Cohort 3

• Progressive disease within 6 months of completion of curatively intended systemic treatment for locally advanced/mHNSCC

• Prior treatment with a taxane

Note: Other protocol defined Inclusion/Exclusion criteria may apply.