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

Trial ID or NCT#

NCT04854499

Status

not recruiting iconNOT RECRUITING

Purpose

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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.
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Investigator(s)

A. Dimitrios Colevas, MD
A. Dimitrios Colevas, MD
Medical oncologist, Head and neck specialist, Cutaneous oncology specialist
Professor of Medicine (Oncology) and, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS) and of Radiation Oncology (Radiation Therapy)

Contact us to find out if this trial is right for you.

Contact

Elizabeth Winters
650-721-6509

View on ClinicalTrials.gov