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

Description

The study consists of Safety Run-in and Phase 2 Cohorts.

The primary objectives of the safety run-in cohorts of this study 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 participants with head and neck squamous cell carcinoma (HNSCC).

Phase 2 Cohorts 1: To evaluate the progression-free survival (PFS) with magrolimab in combination with pembrolizumab + 5-FU + platinum versus pembrolizumab + 5-FU + platinum as assessed by independent central review.

Phase 2 Cohorts 2 and 3: To evaluate the efficacy of magrolimab in combination with pembrolizumab and magrolimab in combination with docetaxel as determined by the investigator-assessed objective response rate (ORR).

Status

Accepting new patients

Primary Study Objective(s)

The primary objectives of this trial is to determine:

  • Safety Run-in Cohorts: Percentage of participants experiencing dose limiting toxicities according to the National Cancer Institute common terminology criteria for adverse events, version 5.0
  • Phase 2 cohorts 1: Progression-free survival
  • Phase 2 cohorts 2 and 3: Objective response rate

Core eligibility

Note: This is only a partial list of eligibility criteria.

Including patients who meet these 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 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

Excluding patients who meet these 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

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
    • 5-FU and platinum-based chemotherapy (Safety Run-in Cohort 1 and Phase 2 Cohorts 1 only)

Safety Run-in Cohort 2 and Phase 2 Cohort 3

  • Progressive disease within six months of completion of curatively intended systemic treatment for locally advanced/mHNSCC
  • Prior treatment with a taxane
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
     

Accepting new patients

 

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