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

ID#: NCT04854499

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 2

Recruitment Status: Recruiting

Start Date: September 07, 2021

End Date: September 01, 2023

Contact Information:
Gilead Clinical Study Information Center
1-833-445-3230 (GILEAD-0)
Summary: The goals of this clinical study are to learn about the safety, tolerability, dosing and effectiveness of the study drug, magrolimab in combination with other anticancer therapies in patients with head and neck squamous cell carcinoma (HNSCC).
Eligibility: 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

- 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.