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Cancer drug combo trial halted early – what we know

NCT ID NCT04854499

Disease control Sponsor: Gilead Sciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a drug called magrolimab combined with other cancer treatments for people with head and neck squamous cell carcinoma that had spread or come back. The goal was to see if the combination was safe and effective. The trial was stopped early, so results are limited.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

193 people

The number who actually took part.

Started

Sep 2021

Finished

Oct 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key 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. Key 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.

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Conditions

The condition(s) this trial relates to.

head and neck squamous cell carcinoma Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Head and neck squamous cell carcinoma

Contacts and locations

Locations

  • ASST degli Spedali Civili di Brescia

    Brescia, 25123, Italy

  • AZ Sint-Maarten

    Mechelen, 2800, Belgium

  • Alfred Health

    Melbourne, Victoria, 3004, Australia

  • Algemeen Ziekenhuis Klina

    Brasschaat, 2930, Belgium

  • Arcispedale Santa Maria Nuova

    Reggio Emilia, 42100, Italy

  • Astera Cancer Care

    East Brunswick, New Jersey, 08816, United States

  • Austin Health

    Heidelberg, Victoria, 3084, Australia

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105, United States

  • Azienda Ospedaliero - Universitaria Senese

    Siena, 53100, Italy

  • Azienda Ospedaliero - Universitaria di Bologna - IRCCS

    Bologna, 40138, Italy

  • Azienda Ospedaliero-Universitaria di Modena - Policlinico

    Modena, 41124, Italy

  • Blacktown Hospital

    Westmead, New South Wales, 2145, Australia

  • CHU UCL Namur - Sainte-Elisabeth

    Namur, 5000, Belgium

  • Cairns Hospital

    Cairns, Queensland, 4870, Australia

  • Centre Georges François Leclerc

    Dijon, 21079, France

  • Centre Hospitalizer De L'Ardenne

    Libramont-Chevigny, 6800, Belgium

  • Centre Léon Bérard

    Lyon, 69373, France

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

    Nice, 6189, France

  • Centro Hospitalar Universitario do Porto

    Porto, 4050-011, Portugal

  • Centro Hospitalar do Algarve

    Faro, 8000-366, Portugal

  • Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy

    Bydgoszcz, 85-796, Poland

  • Charite University Medicine

    Berlin, 10177, Germany

  • City of Hope

    Duarte, California, 91010, United States

  • Civils de Lyon-Centre Hopitalier Lyon Sud

    Pierre-Bénite, 69310, France

  • Clinica Universidad de Navarra

    Pamplona, 31008, Spain

  • Fondazione IRCCS Istituto Nazionale Tumori Milano

    Milan, 20133, Italy

  • Hopital Foch

    Suresnes, 92151, France

  • Hopital Pitie-Salpetriere

    Paris, 75013, France

  • Hopital de la Timone

    Marseille, 13005, France

  • Hospital CUF Descobertas

    Lisbon, 1998-018, Portugal

  • Hospital Clínico Universitario de Valencia

    Valencia, Spain

  • Hospital De La Santa Creu I Sant Pau

    Barcelona, 8041, Spain

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007, Spain

  • Hospital Regional Universitario de Malaga

    Málaga, 29010, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Hospital Universitario Virgen Macarena

    Seville, 41009, Spain

  • Hospital Universitario Virgen del Rocio

    Seville, 41013, Spain

  • Hospital Universitario de Jaen

    Jaén, 23007, Spain

  • Hospital de Braga

    Braga, 4710-243, Portugal

  • Hospital del Mar

    Barcelona, 8003, Spain

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112, United States

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

    New York, New York, 10029, United States

  • Indiana University Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202, United States

  • Institut Bergonie

    Bordeaux, 33000, France

  • Institut Curie

    Paris, 75005, France

  • Institut Gustave Roussy

    Villejuif, 94805, France

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

    Porto, 4200-072, Portugal

  • Ironwood Cancer and Research Center

    Chandler, Arizona, 85224, United States

  • Kath. Marienkrankenhaus gGmbH

    Hamburg, 22087, Germany

  • Lancaster General Hospital

    Lancaster, Pennsylvania, 17602, United States

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • MD Anderson Cancer Center

    Madrid, 28033, Spain

  • Macquarie University

    Macquarie Park, New South Wales, 2109, Australia

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Memorial Healthcare System

    Hollywood, Florida, 33021, United States

  • Musgrove Park Hospital

    Taunton, TA1 5DA, United Kingdom

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

    Warsaw, 2781, Poland

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

    Gliwice, 44-102, Poland

  • New York Cancer and Blood Specialists

    Port Jefferson Station, New York, 11776, United States

  • OU Health Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104, United States

  • Ocala Oncology Center

    Ocala, Florida, 34471, United States

  • Ospedale San Luca Luca

    Lucca, 55100, Italy

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102, Australia

  • Princess Margaret Hospital

    Lai Chi Kok, Hong Kong

  • Providence Medical Foundation

    Santa Rosa, California, 95403, United States

  • Queen Mary Hospital

    Hong Kong, Hong Kong

  • Royal Marsden NHS Foundation Trust, Royal Marsden - Sutton

    London, SM2 5PT, United Kingdom

  • Sanford Roger Maris Cancer Center

    Fargo, North Dakota, 58122, United States

  • St. Vincent's Hospital Sydney

    Darlinghurst, New South Wales, 2010, Australia

  • Stanford Cancer Institute

    Palo Alto, California, 94305, United States

  • Technische Universitat Munchen (TUM) - Klinikum Rechts der Isar

    Munich, 81675, Germany

  • Torrance Memorial Physician Network - Cancer Care Associates

    Redondo Beach, California, 90277, United States

  • UCLA Hematology/Oncology

    Los Angeles, California, 90095, United States

  • UZ Antwerpen

    Edegem, 2650, Belgium

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

    Matosinhos Municipality, 4464-513, Portugal

  • Universitaire Ziekenhuis Leuven

    Leuven, 3000, Belgium

  • Universitatsmedizin Gottingen

    GÃttingen, 37075, Germany

  • University Center and Blood Center,LLC.

    Athens, Georgia, 30607, United States

  • University of the Sunshine Coast

    Sippy Downs, Queensland, 4556, Australia

  • Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik III

    Bonn, 53127, Germany

  • Universitäres Krebszentrum Leipzig

    Leipzig, 4103, Germany

  • Virginia Piper Cancer Center (Alliant Health

    Minneapolis, Minnesota, 55407, United States

  • Washington University of Medicine- Siteman Cancer Center

    St Louis, Missouri, 63110, United States

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

    Poznan, 61-866, Poland

  • Wojewodzki Szpital Specjalistyczny w Siedlcach

    Siedlce, 08-110, Poland

  • ZiekenhuisNetwerk Antwerpen (ZNA) - Stuivenberg

    Antwerp, 2020, Belgium

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