Trial Search Results

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

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).

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Gilead Sciences

Stanford Investigator(s):


  • Drug: Magrolimab
  • Drug: Pembrolizumab
  • Drug: Docetaxel
  • Drug: 5-FU
  • Drug: Cisplatin
  • Drug: Carboplatin
  • Drug: Zimberelimab


Phase 2


Key Inclusion 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

   - 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:

   - 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

Safety Run-in Cohort 2 and Phase 2 Cohort 3

   - Progressive disease within 6 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.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study


Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Elizabeth Winters