Status:
TERMINATED
Study of Magrolimab Combination Therapy in Patients With Head and Neck Squamous Cell Carcinoma
Lead Sponsor:
Gilead Sciences
Conditions:
Head and Neck Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 participants with...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
- Progressive disease within 6 months of completion of curatively intended treatment for locally advanced/mHNSCC.
- 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
- Prior treatment with a taxane.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
September 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 2 2024
Estimated Enrollment :
193 Patients enrolled
Trial Details
Trial ID
NCT04854499
Start Date
September 7 2021
End Date
October 2 2024
Last Update
November 19 2025
Active Locations (88)
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1
Ironwood Cancer and Research Center
Chandler, Arizona, United States, 85224
2
City of Hope
Duarte, California, United States, 91010
3
UCLA Hematology/Oncology
Los Angeles, California, United States, 90095
4
Stanford Cancer Institute
Palo Alto, California, United States, 94305