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STATUS Recruitment Complete

Study of Magrolimab Combination Therapy in Patients With Head and Neck Squamous Cell Carcinoma (ELEVATE HNSCC)

LAST UPDATED

April 11, 2024

Clinicaltrials.gov ID

NCT04854499

CTIS ID

2020-005708-20

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 patients with head and neck squamous cell carcinoma (HNSCC).

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Participation Requirements

Calendar

Age

18 Years +

Condition

Sex

All

Healthy Icon

Healthy Volunteers

No

Study Details

Medical Condition

Head and Neck Squamous Cell Carcinoma

Gender

N/A

Date

September 2021 - July 2025

Study Type

Interventional

Study Phase

Phase 2

Product

Magrolimab, Pembrolizumab, Docetaxel, 5-FU, Cisplatin, Carboplatin, Zimberelimab

Eligibility Information

Inclusion

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.
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Exclusion

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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Locations

Locations (88)
Other

Ironwood Cancer and Research Center

Chandler, Arizona, United States, 85224

Other

City of Hope

Duarte, California, United States, 91010

Other

UCLA Hematology/Oncology

Los Angeles, California, United States, 90095

Other

Stanford Cancer Institute

Palo Alto, California, United States, 94305

Other

Torrance Memorial Physician Network - Cancer Care Associates

Redondo Beach, California, United States, 90277

Other

Providence Medical Foundation

Santa Rosa, California, United States, 95403

Other

Memorial Healthcare System

Hollywood, Florida, United States, 33021

Other

Ocala Oncology Center

Ocala, Florida, United States, 34471

Other

University Center and Blood Center,LLC.

Athens, Georgia, United States, 30607

Other

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, United States, 46202

Other

Virginia Piper Cancer Center (Alliant Health

Minneapolis, Minnesota, United States, 55407

Other

Washington University of Medicine- Siteman Cancer Center

Saint Louis, Missouri, United States, 63110

Other

Astera Cancer Care

East Brunswick, New Jersey, United States, 08816

Other

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

New York, New York, United States, 10029

Other

New York Cancer and Blood Specialists

Port Jefferson Station, New York, United States, 11776

Other

Sanford Roger Maris Cancer Center

Fargo, North Dakota, United States, 58122

Other

OU Health Stephenson Cancer Center

Oklahoma City, Oklahoma, United States, 73104

Other

Lancaster General Hospital

Lancaster, Pennsylvania, United States, 17602

Other

Medical University of South Carolina

Charleston, South Carolina, United States, 29425

Other

Avera Cancer Institute

Sioux Falls, South Dakota, United States, 57105

Other

MD Anderson Cancer Center

Houston, Texas, United States, 77030

Other

Huntsman Cancer Institute

Salt Lake City, Utah, United States, 84112

Other

St. Vincent's Hospital Sydney

Darlinghurst, New South Wales, Australia, 2010

Other

Macquarie University

Macquarie Park, New South Wales, Australia, 2109

Other

Blacktown Hospital

Westmead, New South Wales, Australia, 2145

Other

Cairns Hospital

Cairns, Queensland, Australia, 4870

Other

University of the Sunshine Coast

Sippy Downs, Queensland, Australia, 4556

Other

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia, 4102

Other

Austin Health

Heidelberg, Victoria, Australia, 3084

Other

Alfred Health

Melbourne, Victoria, Australia, 3004

Other

ZiekenhuisNetwerk Antwerpen (ZNA) - Stuivenberg

Antwerpen, Belgium, 2020

Other

Algemeen Ziekenhuis Klina

Brasschaat, Belgium, 2930

Other

UZ Antwerpen

Edegem, Belgium, 2650

Other

Universitaire Ziekenhuis Leuven

Leuven, Belgium, 3000

Other

Centre Hospitalizer De L'Ardenne

Libramont-Chevigny, Belgium, 6800

Other

AZ Sint-Maarten

Mechelen, Belgium, 2800

Other

CHU UCL Namur - Sainte-Elisabeth

Namur, Belgium, 5000

Other

Institut Bergonie

Bordeaux, France, 33000

Other

Centre Georges François Leclerc

Dijon, France, 21079

Other

Centre Léon Bérard

Lyon, France, 69373

Other

Hopital de la Timone

Marseille, France, 13005

Other

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

Nice, France, 6189

Other

Institut Curie

Paris, France, 75005

Other

Hopital Pitie-Salpetriere

Paris, France, 75013

Other

Civils de Lyon-Centre Hopitalier Lyon Sud

Pierre-benite, France, 69310

Other

Hopital Foch

Suresnes, France, 92151

Other

Institut Gustave Roussy

Villejuif, France, 94805

Other

Charite University Medicine

Berlin, Germany, 10177

Other

Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik III

Bonn, Germany, 53127

Other

Universitatsmedizin Gottingen

GÃttingen, Germany, 37075

Other

Kath. Marienkrankenhaus gGmbH

Hamburg, Germany, 22087

Other

Universitäres Krebszentrum Leipzig

Leipzig, Germany, 4103

Other

Technische Universitat Munchen (TUM) - Klinikum Rechts der Isar

Munich, Germany, 81675

Other

Queen Mary Hospital

Hong Kong, Hong Kong

Other

Princess Margaret Hospital

Lai Chi Kok, Hong Kong

Other

Azienda Ospedaliero - Universitaria di Bologna - IRCCS

Bologna, Italy, 40138

Other

ASST degli Spedali Civili di Brescia

Brescia, Italy, 25123

Other

Ospedale San Luca Luca

Lucca, Italy, 55100

Other

Fondazione IRCCS Istituto Nazionale Tumori Milano

Milan, Italy, 20133

Other

Azienda Ospedaliero-Universitaria di Modena - Policlinico

Modena, Italy, 41124

Other

Arcispedale Santa Maria Nuova

Reggio Emilia, Italy, 42100

Other

Azienda Ospedaliero - Universitaria Senese

Siena, Italy, 53100

Other

Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy

Bydgoszcz, Poland, 85-796

Other

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

Gliwice, Poland, 44-102

Other

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

Poznan, Poland, 61-866

Other

Wojewodzki Szpital Specjalistyczny w Siedlcach

Siedlce, Poland, 08-110

Other

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

Warsaw, Poland, 2781

Other

Hospital de Braga

Braga, Portugal, 4710-243

Other

Centro Hospitalar do Algarve

Faro, Portugal, 8000-366

Other

Hospital CUF Descobertas

Lisboa, Portugal, 1998-018

Other

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

Matosinhos, Portugal, 4464-513

Other

Centro Hospitalar Universitario do Porto

Porto, Portugal, 4050-011

Other

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

Porto, Portugal, 4200-072

Other

Hospital Universitari Vall d'Hebron

Barcelona, Spain, 08035

Other

Hospital del Mar

Barcelona, Spain, 8003

Other

Hospital De La Santa Creu I Sant Pau

Barcelona, Spain, 8041

Other

Hospital Universitario de Jaen

Jaen, Spain, 23007

Other

Hospital General Universitario Gregorio Maranon

Madrid, Spain, 28007

Other

MD Anderson Cancer Center

Madrid, Spain, 28033

Other

Hospital Universitario La Paz

Madrid, Spain, 28046

Other

Hospital Regional Universitario de Malaga

Malaga, Spain, 29010

Other

Clinica Universidad de Navarra

Pamplona, Spain, 31008

Other

Hospital Universitario Virgen Macarena

Sevilla, Spain, 41009

Other

Hospital Universitario Virgen del Rocio

Sevilla, Spain, 41013

Other

Hospital Universitari i Politecnic La Fe

Valencia, Spain, 46026

Other

Hospital Clínico Universitario de Valencia

Valencia, Spain

Other

Royal Marsden NHS Foundation Trust, Royal Marsden - Sutton

London, United Kingdom, SM2 5PT

Other

Musgrove Park Hospital

Taunton, United Kingdom, TA1 5DA