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A Study of Amivantamab in Addition to Standard of Care Agents (SOC) Compared With SOC Alone in Participants With Recurrent/Metastatic Head and Neck Cancer
Sponsor: Janssen Research & Development, LLC
Summary
The purpose of this study is to compare anti-tumor activity of amivantamab in addition to pembrolizumab and carboplatin versus pembrolizumab, 5-fluorouracil (FU), and platinum therapy (carboplatin or cisplatin) in participants with refractory/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). HNSCC is a type of cancer that develops in the head and neck regions, including the outer tissue layer of the mouth and throat. This study will focus on participants with HNSCC who are treatment-naive (have not received prior treatment) in the R/M setting.
Official title: A Phase 3, Randomized, Open-Label, Multicenter Study of Amivantamab in Addition to Carboplatin and Pembrolizumab, Compared to Standard of Care Platinum and Pembrolizumab and 5-FU, in Participants With Treatment-Naïve Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
500
Start Date
2025-12-03
Completion Date
2029-06-18
Last Updated
2026-03-13
Healthy Volunteers
No
Conditions
Interventions
Amivantamab
Amivantamab will be administered.
Pembrolizumab
Pembrolizumab will be administered.
Carboplatin
Carboplatin will be administered.
5-Flurouracil
5-Flurouracil will be administered for over 4-day infusion period.
Cisplatin
Cisplatin will be administered.
Locations (137)
Providence St Jude Medical Center
Fullerton, California, United States
Valkyrie Clinical Trials
Los Angeles, California, United States
Valkyrie Clinical Trials Murrieta
Murrieta, California, United States
Hartford Hospital
Hartford, Connecticut, United States
Yale Cancer Center
New Haven, Connecticut, United States
Emory University
Atlanta, Georgia, United States
Central Georgia Cancer Care
Macon, Georgia, United States
Rush University Medical Center Rush University Cancer Center Chicago
Chicago, Illinois, United States
The University of Chicago Medical Center (UCMC)
Chicago, Illinois, United States
Cancer Care Specialists of Central Illinois
O'Fallon, Illinois, United States
University of Kentucky Medical Center
Lexington, Kentucky, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Washington University School Of Medicine
St Louis, Missouri, United States
NHO Revive Research Institute, LLC
Lincoln, Nebraska, United States
Laura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long Island
Mineola, New York, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Bronx Veterans Affairs Medical Center
The Bronx, New York, United States
Carolina Cancer Research Center
Wilson, North Carolina, United States
Oregon Health And Science University
Portland, Oregon, United States
Tennessee Cancer Specialists
Knoxville, Tennessee, United States
Texas Oncology - San Antonio
Fredericksburg, Texas, United States
Texas Oncology-Central South
Waco, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Virginia Cancer Specialists
Arlington, Virginia, United States
Monash Medical Centre
Clayton, Australia
Peter MacCallum Cancer Centre
Melbourne, Australia
St John of God Hospital Murdoch
Murdoch, Australia
GenesisCare
St Leonards, Australia
Universitaetsklinikum Salzburg Landeskrankenhaus
Salzburg, Austria
University Hospital St. Poelten
Sankt Pölten, Austria
UZ Antwerpen
Edegem, Belgium
Chu Helora Hospital La Louviere Site Jolimont
Haine-Saint-Paul, Belgium
Universitair Ziekenhuis Leuven
Leuven, Belgium
Vitaz
Sint-Niklaas, Belgium
Fundacao Doutor Amaral Carvalho
Jaú, Brazil
Liga Norte Riograndense Contra O Cancer
Natal, Brazil
Irmandade da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto - Centro Integrado de Pesquisa
São José do Rio Preto, Brazil
Hospital Alemao Oswaldo Cruz
São Paulo, Brazil
Associacao Feminina de Educacao e Combate ao Cancer Hospital Santa Rita de Cassia
Vitória, Brazil
Tongren Hospital Outpatient Bldg
Beijing, China
The Affiliated Hospital of Bengbu Medical College
Bengbu, China
The second Xiangya Hospital of Central South University
Changsha, China
Hunan Cancer hospital
Changsha, China
Sichuan Cancer Hospital
Chengdu, China
West China Hospital Sichuan University
Chengdu, China
Sichuan Provincial Peoples Hospital
Chengdu, China
Chongqing Cancer Hospital
Chongqing, China
Dongguan People s Hospital
Dongguan, China
Sun Yat-sen University Cancer Hospital
Guangzhou, China
The Affiliated Cancer Hospital of Shandong First Medical University
Jinan, China
Linyi Cancer Hospital
Linyi, China
Nanjing Drum Tower Hospital
Nanjing, China
The Cancer Hospital Affiliated to Guangxi Medical University
Nanning, 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
Fakultni nemocnice Hradec Kralove
Hradec Králové, Czechia
University Hospital Ostrava
Ostrava, Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, Czechia
Motol University Hospital
Prague, Czechia
Krajska nemocnice T. Bati, a.s.
Zlín, Czechia
Institut Sainte Catherine
Avignon, France
Clinique Victor Hugo
Le Mans, France
Centre Oscar Lambret
Lille, France
Assistance Publique Hopitaux de Marseille (AP-HM) - Hopital
Marseille, France
Institut Curie
Paris, France
Assistance Publique - Hopitaux de Paris
Paris, France
Centre Henri Becquerel
Rouen, France
Institut Gustave Roussy
Villejuif, France
Universitaetsklinikum Ulm
Ulm, Germany
Gyor Moson Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Győr, Hungary
Pecsi Tudomanyegyetem Klinikai Kozpont
Pécs, Hungary
Nograd Varmegyei Szent Lazar Korhaz
Salgótarján, Hungary
Apollo Speciality Hospital, Chennai
Chennai, India
Bhagwan Mahaveer Cancer Hospital & Research Centre
Jaipur, India
HealthCare Global HCG Manavata Cancer Centre
Nashik, India
Kailash Cancer Hospital and Research Centre
Vadodara, India
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy
European Institute of Oncology
Milan, Italy
Fondazione G Pascale Istituto Nazionale Tumori IRCCS
Naples, Italy
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
Palermo, Italy
AOU Policlinico Umberto I
Roma, Italy
Istituto Clinico Humanitas
Rozzano, Italy
Kansai Medical University Hospital
Hirakata, Japan
Hokkaido University Hospital
Sapporo, Japan
Tokyo Medical University Hospital
Shinjuku, Japan
National Cancer Center Hospital
Tokyo, Japan
The Cancer Institute Hospital of JFCR
Tokyo, Japan
CO de Chihuahua
Chihuahua City, Mexico
Act. Basada en la Inv. Del Ca
Guadalajara, Mexico
P. y S. Oncologicos Acacias
Mexico City, Mexico
Gefarma Atrys
Mexico City, Mexico
Cuidados Oncologicos
Querétaro, Mexico
Find My Cancer Cen de Inv Clin
Tijuana, Mexico
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz w Gliwicach
Gliwice, Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi
Lodz, Poland
Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli
Lublin, Poland
Wielkopolskie Centrum Onkologii im. Marii Sklodowskiej-Curie
Poznan, Poland
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
Warsaw, Poland
Uls Santa Maria - Hosp. Santa Maria
Lisbon, Portugal
Hosp. Cuf Descobertas
Lisbon, Portugal
Hospital de Portimao-Centro Hospitalar do Barlavento Algarvio
Portimão, Portugal
Instituto Portugues de Oncologia
Porto, Portugal
Uls Gaia Espinho
Vila Nova de Gaia, Portugal
Spitalul Clinic Coltea
Bucharest, Romania
Cardiomed
Cluj-Napoca, Romania
Institutul Oncologic 'Prof Dr. Ion Chiricuta' Cluj-Napoca
Cluj-Napoca, Romania
Clinica de Oncologie Sf Nectarie
Craiova, Romania
Institutul Regional de Oncologie Iasi
Iași, Romania
Oncocenter Oncologie Clinica SRL
Timișoara, Romania
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
Hospital Clinico San Carlos
Madrid, Spain
Hosp. Univ. 12 de Octubre
Madrid, Spain
Complejo Hosp de Navarra - Hosp de Navarra
Pamplona, Spain
Hosp. Clinico Univ. de Santiago
Santiago de Compostela, Spain
Hosp. Univ. Miguel Servet
Zaragoza, Spain
Changhua Christian Hospital
Changhua, Taiwan
Kaohsiung Medical University Chung Ho Memorial Hospital
Kaohsiung City, Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan
China Medical University Hospital
Taichung, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Castle Hill Hospital
Cottingham, United Kingdom
Guy's and St Thomas' NHS Foundation Trust
Greater London, United Kingdom
Royal Surrey County Hospital NHS Trust
Guildford, United Kingdom
St Bartholomew's Hospital
London, United Kingdom
Royal Marsden Hospital
London, United Kingdom
The Clatterbridge Cancer Centre
Metropolitan Borough of Wirral, United Kingdom
Mount Vernon Cancer Centre
Northwood, United Kingdom
Royal Marsden Hospital
Sutton, United Kingdom