Study of Magrolimab Combination Therapy in Patients With Head and Neck Squamous Cell Carcinoma
NCT ID: NCT04854499
Last Updated: 2025-11-19
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
193 participants
INTERVENTIONAL
2021-09-07
2024-10-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Phase 2 Cohort 1, Magrolimab + Pembrolizumab + 5-FU + Platinum (Arm A)
Participants with untreated metastatic or unresectable, locally recurrent HNSCC regardless of PD-L1 status will receive magrolimab at the recommended Phase 2 dose (RP2D) determined in the Safety run-in cohort
1, pembrolizumab 200 mg on Day 1 of each cycle, 5-FU 1000 mg/m\^2/day Days 1-4 of each cycle, and platinum chemotherapy (cisplatin 100 mg/m\^2 or carboplatin AUC 5 per investigator choice). Each cycle is 21 days. Magrolimab will be continued until loss of clinical benefit, unacceptable toxicity, or death.
Pembrolizumab therapy will be administered for up to 24 months or until loss of clinical benefit or unacceptable toxicity, whichever occurs first. 5-FU and platinum chemotherapy will be administered for up to 6 cycles or until loss of clinical benefit or unacceptable toxicity, whichever occurs first.
Magrolimab
Administered intravenously
Pembrolizumab
Administered intravenously
5-FU
Administered intravenously
Cisplatin
Administered intravenously
Carboplatin
Administered intravenously
Phase 2 Cohort 1, Pembrolizumab + 5-FU + Platinum (Arm B)
Participants with untreated metastatic or unresectable, locally recurrent HNSCC regardless of PD-L1 status will receive pembrolizumab 200 mg on Day 1 of each cycle, 5-FU 1000 mg/m\^2/day Days 1-4 of each cycle, and platinum chemotherapy (cisplatin 100 mg/m\^2 or carboplatin AUC 5 per investigator choice). Each cycle is 21 days.
Pembrolizumab therapy will be administered for up to 24 months or until loss of clinical benefit or unacceptable toxicity, whichever occurs first. 5-FU and platinum chemotherapy will be administered for up to 6 cycles or until loss of clinical benefit or unacceptable toxicity, whichever occurs first.
5-FU
Administered intravenously
Cisplatin
Administered intravenously
Carboplatin
Administered intravenously
Phase 2 Cohort 1, Magrolimab + Zimberelimab + 5-FU + Platinum (Arm C)
Participants with untreated metastatic or unresectable, locally recurrent HNSCC regardless of PD-L1 status will receive magrolimab at the recommended Phase 2 dose (RP2D) determined in the Safety run-in cohort 1, zimberelimab 360 mg on Day 1 of each cycle, 5- FU 1000 mg/m\^2/day Days 1-4 of each cycle, and platinum chemotherapy (cisplatin 100 mg/m\^2 or carboplatin AUC 5 per investigator choice). Each cycle is 21 days.
Magrolimab will be continued until loss of clinical benefit, unacceptable toxicity, or death. Zimberelimab therapy will be administered up to 24 months or until loss of clinical benefit or unacceptable toxicity, whichever occurs first. 5-FU and platinum chemotherapy will be administered for up to 6 cycles or until loss of clinical benefit or unacceptable toxicity, whichever occurs first.
Magrolimab
Administered intravenously
5-FU
Administered intravenously
Cisplatin
Administered intravenously
Carboplatin
Administered intravenously
Zimberelimab
Administered intravenously
Phase 2 Cohort 2, Magrolimab + Pembrolizumab
Participants with untreated metastatic or unresectable, locally recurrent HNSCC with a PD-L1 combined positive score (CPS) ≥ 1 will receive magrolimab at the RP2D determined in the Safety run-in cohort 1 and pembrolizumab 200 mg on Day 1 of each cycle. Each cycle is 21 days.
Magrolimab will be continued until loss of clinical benefit, unacceptable toxicity, or death. Pembrolizumab therapy will be administered for up to 24 months or until loss of clinical benefit or unacceptable toxicity, whichever occurs first.
Magrolimab
Administered intravenously
Pembrolizumab
Administered intravenously
Phase 2 Cohort 3, Magrolimab + Docetaxel
Participants with locally advanced/metastatic HNSCC regardless of PD-L1 status who were previously treated with at least 1 and no more than 2 lines of prior systemic therapy will receive magrolimab at the RP2D determined in the Safety run-in cohort 2 and docetaxel 75 mg/m\^2 on Day 1 of each cycle. Each cycle is 21 days.
Magrolimab and docetaxel will be continued until loss of clinical benefit, unacceptable toxicity, or death.
Magrolimab
Administered intravenously
Docetaxel
Administered intravenously
Safety Run-in Cohort 1, Magrolimab + Pembrolizumab + 5-FU + Platinum
Participants with untreated metastatic or unresectable, locally recurrent head and neck squamous cell carcinoma (HNSCC) regardless of programmed cell death ligand 1 (PD-L1) status will receive the following:
* magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses
* pembrolizumab 200 mg on Day 1 of each cycle
* 5-fluorouracil (5-FU) 1000 mg/m\^2/day Days 1-4 of each cycle (for up to 6 cycles)
* platinum chemotherapy (cisplatin 100 mg/m\^2 or carboplatin area under the concentration versus time curve (AUC) 5 per investigator choice (for up to 6 cycles)) Participants will continue treatment until unacceptable toxicity or disease progression, whichever occurs first, and will not change their magrolimab dose level after the recommended Phase 2 dose (RP2D) is determined. Each cycle is 21 days.
Magrolimab
Administered intravenously
Pembrolizumab
Administered intravenously
5-FU
Administered intravenously
Cisplatin
Administered intravenously
Carboplatin
Administered intravenously
Safety Run-in Cohort 2, Magrolimab + Docetaxel
Participants with locally advanced/metastatic HNSCC regardless of PD-L1 status who were previously treated with at least 1 and no more than 2 lines of prior systemic therapy will receive the following:
* magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, beginning at Day 8 and for the next 5 doses
* docetaxel 75 mg/m\^2 on Day 1 of each cycle Participants will continue treatment until unacceptable toxicity or disease progression, whichever occurs first, and will not change their magrolimab dose level after the RP2D is determined. Each cycle is 21 days.
Magrolimab
Administered intravenously
Docetaxel
Administered intravenously
Pre-expansion Safety Run-in Cohort, Magrolimab + Pembrolizumab
The pre-expansion safety run-in cohort may be conducted at the sponsor's discretion prior to the initiation of Phase 2 Cohort 2. Participants with untreated metastatic or unresectable, locally recurrent HNSCC with a PD-L1 combined positive score (CPS) ≥ 1 will receive magrolimab and pembrolizumab 200 mg on Day 1 of each cycle. Each cycle is 21 days.
Participants will continue treatment until unacceptable toxicity or disease progression, whichever occurs first, and will not change their magrolimab dose level after the RP2D is determined. Each cycle is 21 days.
Magrolimab
Administered intravenously
Pembrolizumab
Administered intravenously
Interventions
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Magrolimab
Administered intravenously
Pembrolizumab
Administered intravenously
Docetaxel
Administered intravenously
5-FU
Administered intravenously
Cisplatin
Administered intravenously
Carboplatin
Administered intravenously
Zimberelimab
Administered intravenously
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.
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
* 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.
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Ironwood Cancer and Research Center
Chandler, Arizona, United States
City of Hope
Duarte, California, United States
UCLA Hematology/Oncology
Los Angeles, California, United States
Stanford Cancer Institute
Palo Alto, California, United States
Torrance Memorial Physician Network - Cancer Care Associates
Redondo Beach, California, United States
Providence Medical Foundation
Santa Rosa, California, United States
Memorial Healthcare System
Hollywood, Florida, United States
Ocala Oncology Center
Ocala, Florida, United States
University Center and Blood Center,LLC.
Athens, Georgia, United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
Virginia Piper Cancer Center (Alliant Health
Minneapolis, Minnesota, United States
Washington University of Medicine- Siteman Cancer Center
St Louis, Missouri, United States
Astera Cancer Care
East Brunswick, New Jersey, United States
Icahn School of Medicine at Mount Sinai and the Mount Sinai Hospital
New York, New York, United States
New York Cancer and Blood Specialists
Port Jefferson Station, New York, United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota, United States
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
Lancaster General Hospital
Lancaster, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Avera Cancer Institute
Sioux Falls, South Dakota, United States
MD Anderson Cancer Center
Houston, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
St. Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia
Macquarie University
Macquarie Park, New South Wales, Australia
Blacktown Hospital
Westmead, New South Wales, Australia
Cairns Hospital
Cairns, Queensland, Australia
University of the Sunshine Coast
Sippy Downs, Queensland, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Austin Health
Heidelberg, Victoria, Australia
Alfred Health
Melbourne, Victoria, Australia
ZiekenhuisNetwerk Antwerpen (ZNA) - Stuivenberg
Antwerp, , Belgium
Algemeen Ziekenhuis Klina
Brasschaat, , Belgium
UZ Antwerpen
Edegem, , Belgium
Universitaire Ziekenhuis Leuven
Leuven, , Belgium
Centre Hospitalizer De L'Ardenne
Libramont-Chevigny, , Belgium
AZ Sint-Maarten
Mechelen, , Belgium
CHU UCL Namur - Sainte-Elisabeth
Namur, , Belgium
Institut Bergonie
Bordeaux, , France
Centre Georges François Leclerc
Dijon, , France
Centre Léon Bérard
Lyon, , France
Hopital de la Timone
Marseille, , France
Centre de Lutte Contre le Cancer (CLCC) - Centre Antoine Lacassagne (CAL) - Site Est
Nice, , France
Institut Curie
Paris, , France
Hopital Pitie-Salpetriere
Paris, , France
Civils de Lyon-Centre Hopitalier Lyon Sud
Pierre-Bénite, , France
Hopital Foch
Suresnes, , France
Institut Gustave Roussy
Villejuif, , France
Charite University Medicine
Berlin, , Germany
Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik III
Bonn, , Germany
Universitatsmedizin Gottingen
GÃttingen, , Germany
Kath. Marienkrankenhaus gGmbH
Hamburg, , Germany
Universitäres Krebszentrum Leipzig
Leipzig, , Germany
Technische Universitat Munchen (TUM) - Klinikum Rechts der Isar
Munich, , Germany
Queen Mary Hospital
Hong Kong, , Hong Kong
Princess Margaret Hospital
Lai Chi Kok, , Hong Kong
Azienda Ospedaliero - Universitaria di Bologna - IRCCS
Bologna, , Italy
ASST degli Spedali Civili di Brescia
Brescia, , Italy
Ospedale San Luca Luca
Lucca, , Italy
Fondazione IRCCS Istituto Nazionale Tumori Milano
Milan, , Italy
Azienda Ospedaliero-Universitaria di Modena - Policlinico
Modena, , Italy
Arcispedale Santa Maria Nuova
Reggio Emilia, , Italy
Azienda Ospedaliero - Universitaria Senese
Siena, , Italy
Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy
Bydgoszcz, , Poland
Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie, Panstwowy Instytut Badawczy, Oddzial x Gliwicach
Gliwice, , Poland
Wielkopolskie Centrum Onkologii im. Marii Sklodowskiej-Curie, Oddzial Onkologii Klinicznej i Immunookologii z Poddoddzialem Dziennym i Izba Przyjec
Poznan, , Poland
Wojewodzki Szpital Specjalistyczny w Siedlcach
Siedlce, , Poland
Narodowy Instytut Onkologii im. M. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Klinika Nowotworow Glowy i Szyi
Warsaw, , Poland
Hospital de Braga
Braga, , Portugal
Centro Hospitalar do Algarve
Faro, , Portugal
Hospital CUF Descobertas
Lisbon, , Portugal
Unidade Local de Saude de Matosinhos EPE - Hospital Pedro Hispano SA
Matosinhos Municipality, , Portugal
Centro Hospitalar Universitario do Porto
Porto, , Portugal
Instituto Portugues de Oncologia Do Porto Francisco Gentil,E.P.E.
Porto, , Portugal
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital del Mar
Barcelona, , Spain
Hospital De La Santa Creu I Sant Pau
Barcelona, , Spain
Hospital Universitario de Jaen
Jaén, , Spain
Hospital General Universitario Gregorio Maranon
Madrid, , Spain
MD Anderson Cancer Center
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Regional Universitario de Malaga
Málaga, , Spain
Clinica Universidad de Navarra
Pamplona, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Hospital Universitari i Politecnic La Fe
Valencia, , Spain
Hospital Clínico Universitario de Valencia
Valencia, , Spain
Royal Marsden NHS Foundation Trust, Royal Marsden - Sutton
London, , United Kingdom
Musgrove Park Hospital
Taunton, , United Kingdom
Countries
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References
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Colevas AD, Dinis J, Chin V, Costa DA, Park JJ, Fang B, et al. A Phase 2 Study of Magrolimab Combination Therapy in Patients with Recurrent or Metastatic Head and Neck Squamous-Cell Carcinoma (ELEVATE HNSCC) [Poster TPS6102]. American Society for Clinical Oncology (ASCO); 2023 June 2-6; Chicago, IL.
Colevas AD, Dinis J, Chin V, Costa DA, Park JJ, Fang B, et al. A phase 2 study of magrolimab combination therapy in patients with recurrent or metastatic head and neck squamous cell carcinoma (ELEVATE HNSCC) [Abstract]. American Society for Clinical Oncology (ASCO); 2023 June 2-6; Chicago, IL.
Colevas AD, Kerrigan K, Chin V, Rainey N, Park J, Fang B, et al. Safety and Tolerability of Magrolimab Combination Therapy in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (RM-HNSCC) [Poster #675]. SITC: 38th Society for Immunotherapy of Cancer Annual Meeting; 2023 November 3-5, 2023; San Diego, CA.
Colevas AD, Kerrigan K, Chin V, Rainey N, Park J, Fang B, et al. Safety and tolerability of magrolimab combination therapy in patients with recurrent or metastatic head and neck squamous cell carcinoma (RM-HNSCC) [Abstract]. SITC: 38th Society for Immunotherapy of Cancer Annual Meeting; 2023 November 3-5, 2023; San Diego, CA.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Gilead Clinical Trials Website
Other Identifiers
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2020-005708-20
Identifier Type: OTHER
Identifier Source: secondary_id
GS-US-548-5916
Identifier Type: -
Identifier Source: org_study_id
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