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.
