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RecruitingLast updated: 2 February 2024

This phase II study is assessing how safe and effective different combinations of immunotherapy (magrolimab, pembrolizumab, and zimberelimab) is, with or without chemotherapy (5-FU + platinum chemotherapy, or docetaxel) in people with head and neck squamous cell carcinomaA Phase 2 Study of Magrolimab Combination Therapy in Patients With Head and Neck Squamous Cell Carcinoma

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 patients with head and neck squamous cell carcinoma.

Cancer

Head and Neck Cancers Head and Neck

Age

People18+

Phase

II

More information

Trial Identifiers

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Trial sponsor

Gilead Sciences, Inc.

Scientific Title

A Phase 2 Study of Magrolimab Combination Therapy in Patients 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

  • 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.

Inclusion

  • You have had treatment, but your cancer has come back.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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