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


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Trial ID: NCT04854499


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).

Official Title

A Phase 2 Study of Magrolimab Combination Therapy in Patients With Head and Neck Squamous Cell Carcinoma

Stanford Investigator(s)

A. Dimitrios Colevas, MD
A. Dimitrios Colevas, MD

Professor of Medicine (Oncology) and, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS) and of Radiation Oncology (Radiation Therapy)


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

   - 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.

   - 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.


drug: Magrolimab

drug: Pembrolizumab

drug: Docetaxel

drug: 5-FU

drug: Cisplatin

drug: Carboplatin

drug: Zimberelimab


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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Elizabeth Winters

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