Study of Magrolimab Combination Therapy in Patients With Head and Neck Squamous Cell Carcinoma
Megadott ok: Sponsor decision to terminate study
Key facts
- Where
- Athens, Chandler, Charleston, Duarte, East Brunswick, Fargo, Hollywood, Houston, Indianapolis, Lancaster, Los Angeles, Minneapolis, New York, Ocala, Oklahoma City, Palo Alto, Port Jefferson Station, Redondo Beach, Salt Lake City, Santa Rosa, Sioux Falls és St Louis, Egyesült ÁllamokSee the 22 sites
- Phase
- 2. fázis
Where in Egyesült Államok
- University Center and Blood Center,LLC.Athens, Egyesült ÁllamokNo longer taking part
- Ironwood Cancer and Research CenterChandler, Egyesült ÁllamokNo longer taking part
- Medical University of South CarolinaCharleston, Egyesült ÁllamokNo longer taking part
- City of HopeDuarte, Egyesült ÁllamokNo longer taking part
- Astera Cancer CareEast Brunswick, Egyesült ÁllamokNo longer taking part
- Sanford Roger Maris Cancer CenterFargo, Egyesült ÁllamokNo longer taking part
- Memorial Healthcare SystemHollywood, Egyesült ÁllamokNo longer taking part
- MD Anderson Cancer CenterHouston, Egyesült ÁllamokNo longer taking part
- Indiana University/Melvin and Bren Simon Cancer CenterIndianapolis, Egyesült ÁllamokNo longer taking part
- Lancaster General HospitalLancaster, Egyesült ÁllamokNo longer taking part
- UCLA Hematology-OncologyLos Angeles, Egyesült ÁllamokNo longer taking part
- Virginia Piper Cancer Center (Alliant HealthMinneapolis, Egyesült ÁllamokNo longer taking part
- Icahn School of Medicine at Mount Sinai and The Mount Sinai HospitalNew York, Egyesült ÁllamokNo longer taking part
- Ocala Oncology CenterOcala, Egyesült ÁllamokNo longer taking part
- OU Health Stephenson Cancer CenterOklahoma City, Egyesült ÁllamokNo longer taking part
- Stanford Cancer InstitutePalo Alto, Egyesült ÁllamokNo longer taking part
- New York Cancer and Blood SpecialistsPort Jefferson Station, Egyesült ÁllamokNo longer taking part
- Torrance Memorial Physician Network - Cancer Care AssociatesRedondo Beach, Egyesült ÁllamokNo longer taking part
- Huntsman Cancer InstituteSalt Lake City, Egyesült ÁllamokNo longer taking part
- Providence Medical FoundationSanta Rosa, Egyesült ÁllamokNo longer taking part
- Avera Cancer InstituteSioux Falls, Egyesült ÁllamokNo longer taking part
- Washington University of Medicine- Siteman Cancer CenterSt Louis, Egyesült ÁllamokNo longer taking part
Trial details
- Who runs it
- Gilead Sciences
- Trial code
- NCT04854499
- Record updated
- 2025. november 19.
- Original description
The goals of this clinical study are to learn about the safety, tolerability, dosing and effectiveness of the study drug, magrolimab in combination with other anticancer therapies in participants with head and neck squamous cell carcinoma (HNSCC).Read full original descriptionShow less
A Phase 2 Study of Magrolimab Combination Therapy in Patients With Head and Neck Squamous Cell Carcinoma
The goals of this clinical study are to learn about the safety, tolerability, dosing and effectiveness of the study drug, magrolimab in combination with other anticancer therapies in participants with head and neck squamous cell carcinoma (HNSCC).
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: Prior treatment with a taxane; Note: Other protocol defined Inclusion/Exclusion criteria may apply; 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.