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A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Head and Neck Cancer
Sponsor: Janssen Research & Development, LLC
Summary
The purpose of this study is to determine safety and preliminary efficacy of amivantamab monotherapy, amivantamab in addition to pembrolizumab, amivantamab in addition to paclitaxel and amivantamab in addition to pembrolizumab and carboplatin in participants with recurrent/metastatic head and neck cancer. The study will also confirm the recommended Phase 2 combination dose (RP2CD) for amivantamab in addition to paclitaxel. The safety and preliminary efficacy of amivantamab in addition to pembrolizumab will also be determined in perioperative (before and after surgery) setting in participants with resectable locally advanced head and neck squamous cell carcinoma (HNSCC).
Official title: A Phase 1b/2, Open-label Study of Amivantamab Monotherapy and Amivantamab in Addition to Other Therapeutic Agents in Participants With Head and Neck Squamous Cell Carcinoma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
287
Start Date
2024-04-22
Completion Date
2032-12-27
Last Updated
2026-03-13
Healthy Volunteers
No
Conditions
Interventions
Amivantamab
Amivantamab will be administered subcutaneously.
Pembrolizumab
Pembrolizumab will be administered intravenously.
Paclitaxel
Paclitaxel will be administered intravenously.
Carboplatin
Carboplatin will be administered intravenously.
Locations (55)
University of California at San Diego Moores Cancer Center
La Jolla, California, United States
University of Colorado Denver Anschultz Medical Campus
Aurora, Colorado, United States
Yale Cancer Center
New Haven, Connecticut, United States
The University of Chicago Medical Center (UCMC)
Chicago, Illinois, United States
University of Maryland School of Medicine
Baltimore, Maryland, United States
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Washington University School Of Medicine
St Louis, Missouri, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
University of Utah Huntsman Cancer Institute
Salt Lake City, Utah, United States
University of Virginia
Charlottesville, Virginia, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States
Beijing Cancer Hospital of Peking University
Beijing, China
West China School of Medicine/West China Hospital, Sichuan University
Cheng Du Shi, China
Linyi Cancer Hospital
Linyi, China
Fudan Cancer Hospital
Shanghai, China
Shanghai East Hospital
Shanghai, China
Union Hospital Tongji Medical College of Huazhong University of Science and Technology
Wuhan, China
Institut Sainte Catherine
Avignon, France
Centre Oscar Lambret
Lille, France
CHU Nantes
Nantes, France
Institut Curie
Paris, France
Gustave Roussy
Villejuif, France
Universitaetsklinikum Essen
Essen, Germany
Universitaetsklinikum Leipzig
Leipzig, Germany
Klinikum der Landeshauptstadt Stuttgart
Stuttgart, Germany
Aichi Cancer Center
Nagoya, Japan
Tokyo Medical University Hospital
Tokyo, Japan
Pantai Hospital Kuala Lumpur
Kuala Lumpur, Malaysia
University Malaya Medical Centre
Kuala Lumpur, Malaysia
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland
Centrum Onkologii Instytut im M Sklodowskiej Curie Oddzial w Gliwicach
Gliwice, Poland
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
Warsaw, Poland
Seoul National University Hospital
Seoul, South Korea
Severance Hospital Yonsei University Health System
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Hosp Univ Vall D Hebron
Barcelona, Spain
Inst. Cat. Doncologia-H Duran I Reynals
Barcelona, Spain
Hosp. Univ. Ramon Y Cajal
Madrid, Spain
Hosp. Univ. 12 de Octubre
Madrid, Spain
Changhua Christian Hospital
Changhua, Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Linkou Chang Gung Memorial Hospital
Taoyuan District, Taiwan
Addenbrooke's Hospital
Cambridge, United Kingdom
The Royal Surrey County Hospital NHS Foundation Trust
Guildford, United Kingdom
Royal Marsden Hospital (Sutton)
London, United Kingdom
Royal Marsden Hospital
London, United Kingdom
Imperial College London and Imperial College Healthcare NHS Trust
London, United Kingdom
University College London Hospitals
London, United Kingdom
The Christie Nhs Foundation Trust
Manchester, United Kingdom