OVERVIEW
A Phase 2 Study of Magrolimab Combination Therapy in Patients With Head and Neck Squamous Cell Carcinoma (ELEVATE HNSCC)
PROTOCOL SUMMARY
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).
View moreParticipation requirements
Age
18 years +
Sex
All
Healthy Volunteers
No
Age
18 years +
Sex
All
Healthy Volunteers
No
Study details
Medical Condition
Head and Neck Squamous Cell Carcinoma
Gender
N/A
Date
September 2021 - October 2024
Study Type
Interventional
Study Phase
Phase 2
Product
Magrolimab, Pembrolizumab, Docetaxel, 5-FU, Cisplatin, Carboplatin, Zimberelimab
Eligibility information
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 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 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.
- 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
- Prior treatment with a taxane.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Locations
Locations (88)
Ironwood Cancer and Research Center
Chandler, Arizona, United States, 85224
UCLA Hematology/Oncology
Los Angeles, California, United States, 90095
Stanford Cancer Institute
Palo Alto, California, United States, 94305
Torrance Memorial Physician Network - Cancer Care Associates
Redondo Beach, California, United States, 90277
Providence Medical Foundation
Santa Rosa, California, United States, 95403
University Center and Blood Center,LLC.
Athens, Georgia, United States, 30607
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
Virginia Piper Cancer Center (Alliant Health
Minneapolis, Minnesota, United States, 55407
Washington University of Medicine- Siteman Cancer Center
St Louis, Missouri, United States, 63110
Icahn School of Medicine at Mount Sinai and the Mount Sinai Hospital
New York, New York, United States, 10029
New York Cancer and Blood Specialists
Port Jefferson Station, New York, United States, 11776
Sanford Roger Maris Cancer Center
Fargo, North Dakota, United States, 58122
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, United States, 73104
Lancaster General Hospital
Lancaster, Pennsylvania, United States, 17602
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
St. Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia, 2010
Macquarie University
Macquarie Park, New South Wales, Australia, 2109
University of the Sunshine Coast
Sippy Downs, Queensland, Australia, 4556
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
ZiekenhuisNetwerk Antwerpen (ZNA) - Stuivenberg
Antwerp, Belgium, 2020
Centre de Lutte Contre le Cancer (CLCC) - Centre Antoine Lacassagne (CAL) - Site Est
Nice, France, 6189
Civils de Lyon-Centre Hopitalier Lyon Sud
Pierre-Bénite, France, 69310
Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik III
Bonn, Germany, 53127
Technische Universitat Munchen (TUM) - Klinikum Rechts der Isar
Munich, Germany, 81675
Azienda Ospedaliero - Universitaria di Bologna - IRCCS
Bologna, Italy, 40138
Fondazione IRCCS Istituto Nazionale Tumori Milano
Milan, Italy, 20133
Azienda Ospedaliero-Universitaria di Modena - Policlinico
Modena, Italy, 41124
Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy
Bydgoszcz, Poland, 85-796
Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie, Panstwowy Instytut Badawczy, Oddzial x Gliwicach
Gliwice, Poland, 44-102
Wielkopolskie Centrum Onkologii im. Marii Sklodowskiej-Curie, Oddzial Onkologii Klinicznej i Immunookologii z Poddoddzialem Dziennym i Izba Przyjec
Poznan, Poland, 61-866
Wojewodzki Szpital Specjalistyczny w Siedlcach
Siedlce, Poland, 08-110
Narodowy Instytut Onkologii im. M. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Klinika Nowotworow Glowy i Szyi
Warsaw, Poland, 2781
Unidade Local de Saude de Matosinhos EPE - Hospital Pedro Hispano SA
Matosinhos Municipality, Portugal, 4464-513
Instituto Portugues de Oncologia Do Porto Francisco Gentil,E.P.E.
Porto, Portugal, 4200-072
Royal Marsden NHS Foundation Trust, Royal Marsden - Sutton
London, United Kingdom, SM2 5PT
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