Phase 2 study of Magrolimab Combination Therapy in HNSCC
Research type
Research Study
Full title
A Phase 2 Study of Magrolimab Combination Therapy in Patients With Head and Neck Squamous Cell Carcinoma
IRAS ID
1004779
Contact name
Kevin Harrington
Contact email
Sponsor organisation
Gilead Sciences, Inc.
Eudract number
2020-005708-20
Clinicaltrials.gov Identifier
Research summary
Head and neck squamous cell carcinoma (HNSCC) is a cancer that develops in the mucous membranes of the mouth, nose and throat. Depending on the location, HNSCC can cause a variety of symptoms, e.g. ulcers in the mouth/ throat, unusual bleeding or pain, continued sinus congestion, sore throat, earache, and difficulty breathing. The standard treatment for HNSCC currently includes a combination of radiation therapy, surgery and/ or chemotherapy.
This study will investigate a new drug called Magrolimab in combination with other approved treatments for HNSCC. These treatments are pembrolizumab + 5-fluorouracil (5-FU) + chemotherapy; pembrolizumab only; ; zimberelimab + platinum + 5-FU; and docetaxel only.
Magrolimab is not currently approved and is being studied in multiple types of cancers.
The aim of the study is to evaluate Magrolimab in combination with pembrolizumab only, and pembrolizumab + 5-FU + chemotherapy and with zimberelimab + platinum + 5-FU in patients with untreated metastatic HNSCC. Magrolimab will also be evaluated in combination with docetaxel in patients with metastatic HNSCC who have received prior treatment.
The study is split into 2 phases; initial phase to confirm the recommended dose of Magrolimab in combination with the other treatments and the second phase to evaluate the effectiveness of the combined treatments.
There will be approximately 297 participants in the study across 100 locations globally. Participants will be allocated into a cohort depending on their treatment history and will receive treatment in 21-day cycles. Participants will undergo multiple types of assessments, e.g. blood tests, physical examinations, CT/MRI scans and quality of life questionnaires.REC name
South Central - Hampshire A Research Ethics Committee
REC reference
22/SC/0175
Date of REC Opinion
22 Aug 2022
REC opinion
Further Information Favourable Opinion