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

NCT04854499 | Terminated Phase 2 Results FDA Drug

• 2 other identifiers: GS-US-548-59162020-005708-20
• Study Type: interventional
• Target: 193
• Locations: 11 countries
• Sites: 88

Brief 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).

Conditions

Head and Neck Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (4)

• Safety Run-in Cohorts 1 and 2: Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs) According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0

  A DLT was defined as any Grade 3 or higher hematologic toxicity or Grade 3 or higher nonhematologic toxicity that had worsened in severity from pretreatment baseline during the DLT assessment period and, in the opinion of the investigator, the AE was related to magrolimab and the relationship of the AE with the combination partner regimen can be ruled out.

  First dose date up to 21 days

• Safety Run-in Cohorts 1 and 2: Percentage of Participants Experiencing Grade 3 or 4 Laboratory Abnormalities

  Treatment-emergent laboratory abnormalities were defined as values that increase at least 1 toxicity grade from baseline at any postbaseline time point up to and including last dose date of study drug plus 30 days (or last dose date of zimberelimab plus 90 days) and prior to the day of initiation of subsequent anti-cancer therapy.

  First dose date up to 73 weeks plus 30 days

• Phase 2 Cohort 1, Arms A and B: Progression-free Survival (PFS)

  PFS was defined as the time from the date of randomization until the earliest date of documented disease progression, as assessed by investigator assessment, or death from any cause, whichever occurred first. Progressive disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). Kaplan-Meier (KM) estimates were used in outcome measure analysis.

  Up to 129 weeks

• Phase 2 Cohort 3: Objective Response Rate (ORR)

  ORR was defined as the percentage of participants who achieved a complete response (CR) or partial response (PR) as measured by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 as determined by investigator assessment. CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

  Up to 129 weeks

Secondary Outcomes (11)

• Safety Run-in Cohort 1 and 2, Phase 2 Cohort 1 Arm A and Phase 2 Cohort 3: Serum Concentration of Magrolimab

  Day 8 1-Hour Postdose; Days 15, 22, 43: Predose; Day 43 1-Hour Postdose; Day 71 1-Hour Postdose; Days 85,127, 190,197, 211, 253 Predose; Day 253 1-Hour Postdose

• Safety Run-in Cohort 1 and 2, Phase 2 Cohort 1 Arm A, C and Phase 2 Cohort 3: Percentage of Participants Who Developed Antidrug Antibodies (ADAs) to Magrolimab

  Up to end of treatment (up to approximately 73 weeks)

• Phase 2 Cohort 1, Arms B and C: Progression-free Survival (PFS)

  Up to 129 weeks

• Phase 2 Cohort 1, Arms A, B and C: Objective Response Rate (ORR)

  Up to 129 weeks

• Phase 2 Cohort 3: Progression-free Survival (PFS)

  Up to 129 weeks

Study Arms (8)

Safety Run-in Cohort 1, Magrolimab + Pembrolizumab + 5-FU + Platinum

EXPERIMENTAL

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.

Drug: Magrolimab; Drug: Pembrolizumab; Drug: 5-FU; Drug: Cisplatin; Drug: Carboplatin

Safety Run-in Cohort 2, Magrolimab + Docetaxel

EXPERIMENTAL

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.

Drug: Magrolimab; Drug: Docetaxel

Pre-expansion Safety Run-in Cohort, Magrolimab + Pembrolizumab

EXPERIMENTAL

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.

Drug: Magrolimab; Drug: Pembrolizumab

Phase 2 Cohort 1, Magrolimab + Pembrolizumab + 5-FU + Platinum (Arm A)

EXPERIMENTAL

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.

Drug: Magrolimab; Drug: Pembrolizumab; Drug: 5-FU; Drug: Cisplatin; Drug: Carboplatin

Phase 2 Cohort 1, Pembrolizumab + 5-FU + Platinum (Arm B)

ACTIVE COMPARATOR

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.

Drug: 5-FU; Drug: Cisplatin; Drug: Carboplatin

Phase 2 Cohort 1, Magrolimab + Zimberelimab + 5-FU + Platinum (Arm C)

ACTIVE COMPARATOR

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.

Drug: Magrolimab; Drug: 5-FU; Drug: Cisplatin; Drug: Carboplatin; Drug: Zimberelimab

Phase 2 Cohort 2, Magrolimab + Pembrolizumab

EXPERIMENTAL

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.

Drug: Magrolimab; Drug: Pembrolizumab

Phase 2 Cohort 3, Magrolimab + Docetaxel

EXPERIMENTAL

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.

Drug: Magrolimab; Drug: Docetaxel

Interventions

Magrolimab DRUG

Administered intravenously

Also known as: GS-4721

Phase 2 Cohort 1, Magrolimab + Pembrolizumab + 5-FU + Platinum (Arm A); Phase 2 Cohort 1, Magrolimab + Zimberelimab + 5-FU + Platinum (Arm C); Phase 2 Cohort 2, Magrolimab + Pembrolizumab; Phase 2 Cohort 3, Magrolimab + Docetaxel; Pre-expansion Safety Run-in Cohort, Magrolimab + Pembrolizumab; Safety Run-in Cohort 1, Magrolimab + Pembrolizumab + 5-FU + Platinum; Safety Run-in Cohort 2, Magrolimab + Docetaxel

Pembrolizumab DRUG

Administered intravenously

Also known as: KEYTRUDA®

Phase 2 Cohort 1, Magrolimab + Pembrolizumab + 5-FU + Platinum (Arm A); Phase 2 Cohort 2, Magrolimab + Pembrolizumab; Pre-expansion Safety Run-in Cohort, Magrolimab + Pembrolizumab; Safety Run-in Cohort 1, Magrolimab + Pembrolizumab + 5-FU + Platinum

Docetaxel DRUG

Administered intravenously

Phase 2 Cohort 3, Magrolimab + Docetaxel; Safety Run-in Cohort 2, Magrolimab + Docetaxel

5-FU DRUG

Administered intravenously

Phase 2 Cohort 1, Magrolimab + Pembrolizumab + 5-FU + Platinum (Arm A); Phase 2 Cohort 1, Magrolimab + Zimberelimab + 5-FU + Platinum (Arm C); Phase 2 Cohort 1, Pembrolizumab + 5-FU + Platinum (Arm B); Safety Run-in Cohort 1, Magrolimab + Pembrolizumab + 5-FU + Platinum

Cisplatin DRUG

Administered intravenously

Phase 2 Cohort 1, Magrolimab + Pembrolizumab + 5-FU + Platinum (Arm A); Phase 2 Cohort 1, Magrolimab + Zimberelimab + 5-FU + Platinum (Arm C); Phase 2 Cohort 1, Pembrolizumab + 5-FU + Platinum (Arm B); Safety Run-in Cohort 1, Magrolimab + Pembrolizumab + 5-FU + Platinum

Carboplatin DRUG

Administered intravenously

Phase 2 Cohort 1, Magrolimab + Pembrolizumab + 5-FU + Platinum (Arm A); Phase 2 Cohort 1, Magrolimab + Zimberelimab + 5-FU + Platinum (Arm C); Phase 2 Cohort 1, Pembrolizumab + 5-FU + Platinum (Arm B); Safety Run-in Cohort 1, Magrolimab + Pembrolizumab + 5-FU + Platinum

Zimberelimab DRUG

Administered intravenously

Phase 2 Cohort 1, Magrolimab + Zimberelimab + 5-FU + Platinum (Arm C)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (88)

Ironwood Cancer and Research Center

Chandler, Arizona, 85224, United States

Location

City of Hope

Duarte, California, 91010, United States

Location

UCLA Hematology/Oncology

Los Angeles, California, 90095, United States

Location

Stanford Cancer Institute

Palo Alto, California, 94305, United States

Location

Torrance Memorial Physician Network - Cancer Care Associates

Redondo Beach, California, 90277, United States

Location

Providence Medical Foundation

Santa Rosa, California, 95403, United States

Location

Memorial Healthcare System

Hollywood, Florida, 33021, United States

Location

Ocala Oncology Center

Ocala, Florida, 34471, United States

Location

University Center and Blood Center,LLC.

Athens, Georgia, 30607, United States

Location

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Virginia Piper Cancer Center (Alliant Health

Minneapolis, Minnesota, 55407, United States

Location

Washington University of Medicine- Siteman Cancer Center

St Louis, Missouri, 63110, United States

Location

Astera Cancer Care

East Brunswick, New Jersey, 08816, United States

Location

Icahn School of Medicine at Mount Sinai and the Mount Sinai Hospital

New York, New York, 10029, United States

Location

New York Cancer and Blood Specialists

Port Jefferson Station, New York, 11776, United States

Location

Sanford Roger Maris Cancer Center

Fargo, North Dakota, 58122, United States

Location

OU Health Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

Location

Lancaster General Hospital

Lancaster, Pennsylvania, 17602, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Avera Cancer Institute

Sioux Falls, South Dakota, 57105, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

St. Vincent's Hospital Sydney

Darlinghurst, New South Wales, 2010, Australia

Location

Macquarie University

Macquarie Park, New South Wales, 2109, Australia

Location

Blacktown Hospital

Westmead, New South Wales, 2145, Australia

Location

Cairns Hospital

Cairns, Queensland, 4870, Australia

Location

University of the Sunshine Coast

Sippy Downs, Queensland, 4556, Australia

Location

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

Location

Austin Health

Heidelberg, Victoria, 3084, Australia

Location

Alfred Health

Melbourne, Victoria, 3004, Australia

Location

ZiekenhuisNetwerk Antwerpen (ZNA) - Stuivenberg

Antwerp, 2020, Belgium

Location

Algemeen Ziekenhuis Klina

Brasschaat, 2930, Belgium

Location

UZ Antwerpen

Edegem, 2650, Belgium

Location

Universitaire Ziekenhuis Leuven

Leuven, 3000, Belgium

Location

Centre Hospitalizer De L'Ardenne

Libramont-Chevigny, 6800, Belgium

Location

AZ Sint-Maarten

Mechelen, 2800, Belgium

Location

CHU UCL Namur - Sainte-Elisabeth

Namur, 5000, Belgium

Location

Institut Bergonie

Bordeaux, 33000, France

Location

Centre Georges François Leclerc

Dijon, 21079, France

Location

Centre Léon Bérard

Lyon, 69373, France

Location

Hopital de la Timone

Marseille, 13005, France

Location

Centre de Lutte Contre le Cancer (CLCC) - Centre Antoine Lacassagne (CAL) - Site Est

Nice, 6189, France

Location

Institut Curie

Paris, 75005, France

Location

Hopital Pitie-Salpetriere

Paris, 75013, France

Location

Civils de Lyon-Centre Hopitalier Lyon Sud

Pierre-Bénite, 69310, France

Location

Hopital Foch

Suresnes, 92151, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

Charite University Medicine

Berlin, 10177, Germany

Location

Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik III

Bonn, 53127, Germany

Location

Universitatsmedizin Gottingen

GÃttingen, 37075, Germany

Location

Kath. Marienkrankenhaus gGmbH

Hamburg, 22087, Germany

Location

Universitäres Krebszentrum Leipzig

Leipzig, 4103, Germany

Location

Technische Universitat Munchen (TUM) - Klinikum Rechts der Isar

Munich, 81675, Germany

Location

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Princess Margaret Hospital

Lai Chi Kok, Hong Kong

Location

Azienda Ospedaliero - Universitaria di Bologna - IRCCS

Bologna, 40138, Italy

Location

ASST degli Spedali Civili di Brescia

Brescia, 25123, Italy

Location

Ospedale San Luca Luca

Lucca, 55100, Italy

Location

Fondazione IRCCS Istituto Nazionale Tumori Milano

Milan, 20133, Italy

Location

Azienda Ospedaliero-Universitaria di Modena - Policlinico

Modena, 41124, Italy

Location

Arcispedale Santa Maria Nuova

Reggio Emilia, 42100, Italy

Location

Azienda Ospedaliero - Universitaria Senese

Siena, 53100, Italy

Location

Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy

Bydgoszcz, 85-796, Poland

Location

Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie, Panstwowy Instytut Badawczy, Oddzial x Gliwicach

Gliwice, 44-102, Poland

Location

Wielkopolskie Centrum Onkologii im. Marii Sklodowskiej-Curie, Oddzial Onkologii Klinicznej i Immunookologii z Poddoddzialem Dziennym i Izba Przyjec

Poznan, 61-866, Poland

Location

Wojewodzki Szpital Specjalistyczny w Siedlcach

Siedlce, 08-110, Poland

Location

Narodowy Instytut Onkologii im. M. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Klinika Nowotworow Glowy i Szyi

Warsaw, 2781, Poland

Location

Hospital de Braga

Braga, 4710-243, Portugal

Location

Centro Hospitalar do Algarve

Faro, 8000-366, Portugal

Location

Hospital CUF Descobertas

Lisbon, 1998-018, Portugal

Location

Unidade Local de Saude de Matosinhos EPE - Hospital Pedro Hispano SA

Matosinhos Municipality, 4464-513, Portugal

Location

Centro Hospitalar Universitario do Porto

Porto, 4050-011, Portugal

Location

Instituto Portugues de Oncologia Do Porto Francisco Gentil,E.P.E.

Porto, 4200-072, Portugal

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital del Mar

Barcelona, 8003, Spain

Location

Hospital De La Santa Creu I Sant Pau

Barcelona, 8041, Spain

Location

Hospital Universitario de Jaen

Jaén, 23007, Spain

Location

Hospital General Universitario Gregorio Maranon

Madrid, 28007, Spain

Location

MD Anderson Cancer Center

Madrid, 28033, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Regional Universitario de Malaga

Málaga, 29010, Spain

Location

Clinica Universidad de Navarra

Pamplona, 31008, Spain

Location

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

Location

Hospital Universitario Virgen del Rocio

Seville, 41013, Spain

Location

Hospital Universitari i Politecnic La Fe

Valencia, 46026, Spain

Location

Hospital Clínico Universitario de Valencia

Valencia, Spain

Location

Royal Marsden NHS Foundation Trust, Royal Marsden - Sutton

London, SM2 5PT, United Kingdom

Location

Musgrove Park Hospital

Taunton, TA1 5DA, United Kingdom

Location

Related Publications (4)

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

Related Links

• Gilead Clinical Trials Website

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

magrolimab; pembrolizumab; Docetaxel; Fluorouracil; Cisplatin; Carboplatin; zimberelimab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes

Results Point of Contact

• Title: Gilead Clinical Study Information Center
• Organization: Gilead Sciences

GileadClinicalTrials@gilead.com

1-833-445-3230 (GILEAD-0)

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2021
• First Posted: April 22, 2021
• Study Start: September 7, 2021
• Primary Completion: October 2, 2024
• Study Completion: October 2, 2024
• Last Updated: November 19, 2025
• Results First Posted: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (7); AU (8); US (22); FR (10); DE (6); PL (5); PT (6); ES (13); GB (2); HK (2); BE (7)