Trial purpose
Cancer treatment
Tumor type
Head and Neck
Age
18+
Clinical summary
Summary
This study consists of a Safety Run-in and Phase 2 Cohorts. The primary objective of the safety run-in cohorts are to evaluate the safety, tolerability, and recommended Phase 2 dose (RP2D) of magrolimab in combination with pembrolizumab + 5-fluorouracil (5-FU) + platinum chemotherapy, and docetaxel in combination with magrolimab. In Safety Run-in Cohort 1, participants will receive magrolimab + pembrolizumab + 5-FU + platinum chemotherapy, all administered intravenously. In Safety Run-in Cohort 2, participants will receive magrolimab + docetaxel, both administered intravenously. In the Pre-expansion Safety Run-in Cohort, participants will receive magrolimab + pembrolizumab, both administered intravenously. The objective of the Phase 2 cohorts are to evaluate the effectiveness of these treatments. In the Phase 2 Cohort 1 (Arm A), participants will receive magrolimab + pembrolizumab + 5-FU + platinum chemotherapy, all administered intravenously. In the Phase 2 Cohort 1 (Arm B), participants will receive pembrolizumab + 5-FU + platinum chemotherapy. In the Phase 2 Cohort 1 (Arm C), participants will receive magrolimab + zimberelimab + 5-FU + platinum chemotherapy. In the Phase 2 Cohort 2, participants will receive magrolimab + pembrolizumab. In the Phase 2 Cohort 3, participants will receive magrolimab + docetaxel.
Conditions
This trial is treating people with head and neck squamous cell carcinoma
Eligibility
Inclusion
- 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.
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
Safety Run-in Cohort 2 and Phase 2 Cohort 3
- Prior treatment with a taxane.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Inclusion
- You have had treatment, but your cancer has come back (relapsed or recurrent).
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
- Your cancer has not spread to other parts of the body (localised).
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Gilead Sciences, Inc.
Scientific Title
A Phase 2 Study of Magrolimab Combination Therapy in Patients With Head and Neck Squamous Cell Carcinoma
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