Study of Magrolimab Combination Therapy in Patients With Head and Neck Squamous Cell Carcinoma
Study Phase: Phase 2
Recruitment Status: Recruiting
Start Date: September 07, 2021
End Date: September 01, 2023
Gilead Clinical Study Information Center
1-833-445-3230 (GILEAD-0)
1-833-445-3230 (GILEAD-0)
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
- Should not have had prior systemic therapy administered in the recurrent or metastatic setting.
- Eligible primary tumor locations include oropharynx, oral cavity, hypopharynx, and larynx. Nasopharynx is not included.
- HNSCC per protocol specified inclusion criteria regardless of PD-L1 status 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 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.