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
Start Date
12/3/2025
Completion Date
6/18/2029
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Amivantamab
Pembrolizumab
Carboplatin
5-Flurouracil
Cisplatin
Conditions
Locations
Ironwood Cancer and Research Center
Chandler, Arizona 85224
United States
University of Arizona Cancer Center
Tucson, Arizona 85719
United States
Providence St Jude Medical Center
Fullerton, California 92835
United States
Scripps Health
La Jolla, California 92037
United States
Valkyrie Clinical Trials
Los Angeles, California 90067
United States
University of California, Los Angeles UCLA
Los Angeles, California 90095
United States
Valkyrie Clinical Trials Murrieta
Murrieta, California 92562
United States
University Of California - Davis
Sacramento, California 95817
United States
Stanford University Medical Center
Stanford, California 94304
United States
Hartford Hospital
Hartford, Connecticut 06102
United States
Yale Cancer Center
New Haven, Connecticut 06510
United States
Florida Cancer Specialists South
Fort Myers, Florida 33901
United States
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida 33136
United States
AdventHealth Medical Group Oncology and Hematology at Orlando
Orlando, Florida 32804
United States
Florida Cancer Specialists North Region
St. Petersburg, Florida 33701-4553
United States
Florida Cancer Specialists East
West Palm Beach, Florida 33401-3406
United States
Emory University
Atlanta, Georgia 30308
United States
Central Georgia Cancer Care
Macon, Georgia 31210
United States
Rush University Medical Center Rush University Cancer Center Chicago
Chicago, Illinois 60607
United States
The University of Chicago Medical Center (UCMC)
Chicago, Illinois 60637
United States
Cancer Care Specialists of Central Illinois
O'Fallon, Illinois 62269
United States
University of Kentucky Medical Center
Lexington, Kentucky 40536
United States
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland 21201
United States
Dana Farber Cancer Institute
Boston, Massachusetts 02115
United States
Trinity Health St Joseph Mercy Ann Arbor
Ann Arbor, Michigan 48197
United States
Karmanos Cancer Institute
Detroit, Michigan 48201 2013
United States
Washington University School Of Medicine
St Louis, Missouri 63108
United States
NHO Revive Research Institute, LLC
Lincoln, Nebraska 68506
United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08903
United States
Laura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long Island
Mineola, New York 11501
United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York 10016
United States
Montefiore Medical Center
The Bronx, New York 10461
United States
Bronx Veterans Affairs Medical Center
The Bronx, New York 10468
United States
Carolina Cancer Research Center
Wilson, North Carolina 27893
United States
University of Cincinnati
Cincinnati, Ohio 45219
United States
Ohio State University
Columbus, Ohio 43210
United States
Oregon Health And Science University
Portland, Oregon 97239
United States
Tennessee Cancer Specialists
Knoxville, Tennessee 37909
United States
Vanderbilt University Medical Center
Nashville, Tennessee 37232
United States
UT Southwestern Medical Center
Dallas, Texas 75390
United States
Texas Oncology - San Antonio
Fredericksburg, Texas 78624
United States
MD Anderson Cancer Center
Houston, Texas 77030
United States
Texas Oncology-Central South
Waco, Texas 76712
United States
Huntsman Cancer Institute
Salt Lake City, Utah 84112
United States
University of Virginia
Charlottesville, Virginia 22908
United States
Virginia Cancer Specialists
Fairfax, Virginia 22031
United States
Monash Medical Centre
Clayton, 3168
Australia
Liverpool Hospital
Liverpool, 2170
Australia
Peter MacCallum Cancer Centre
Melbourne, 3000
Australia
St John of God Hospital Murdoch
Murdoch, 6150
Australia
GenesisCare
St Leonards, 2065
Australia
Tirol Kliniken MedUni Innsbruck
Innsbruck, 6020
Austria
Burgenlaendische Krankenanstalten Gesellschaft M B H Klinik Oberwart
Oberwart, A-7400
Austria
Universitaetsklinikum Salzburg Landeskrankenhaus
Salzburg, A-5020
Austria
University Hospital St. Poelten
Sankt Pölten, A-3100
Austria
Medical University Vienna MUV
Vienna, A 1090
Austria
UZ Antwerpen
Edegem, 2650
Belgium
Chu Helora Hospital La Louviere Site Jolimont
Haine-Saint-Paul, 7100
Belgium
Universitair Ziekenhuis Leuven
Leuven, 3000
Belgium
Vitaz
Sint-Niklaas, 9100
Belgium
Institut Roi Albert II
Woluwe-Saint-Lambert, 1200
Belgium
Fundacao Doutor Amaral Carvalho
Jaú, 17210 080
Brazil
Liga Norte Riograndense Contra O Cancer
Natal, 59062 000
Brazil
Irmandade da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, 90020 090
Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto - Centro Integrado de Pesquisa
São José do Rio Preto, 15090-0000
Brazil
Hospital Alemao Oswaldo Cruz
São Paulo, 01323 903
Brazil
Associacao Feminina de Educacao e Combate ao Cancer Hospital Santa Rita de Cassia
Vitória, 29043 260
Brazil
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, 100021
China
Tongren Hospital Outpatient Bldg
Beijing, 100051
China
Beijing Cancer Hospital
Beijing, 100142
China
The Affiliated Hospital of Bengbu Medical College
Bengbu, 233099
China
The second Xiangya Hospital of Central South University
Changsha, 410011
China
Hunan Cancer hospital
Changsha, 410013
China
Sichuan Cancer Hospital
Chengdu, 610041
China
West China Hospital Sichuan University
Chengdu, 610041
China
Sichuan Provincial Peoples Hospital
Chengdu, 610072
China
Chongqing Cancer Hospital
Chongqing, 400015
China
Dongguan People s Hospital
Dongguan, 523063
China
Sun Yat-sen University Cancer Hospital
Guangzhou, 510060
China
Zhejiang Cancer Hospital
Hangzhou, 310022
China
The Affiliated Cancer Hospital of Shandong First Medical University
Jinan, 250117
China
Yunnan Cancer Hospital
Kunming, 650100
China
Linyi Cancer Hospital
Linyi, 276002
China
Nanjing Drum Tower Hospital
Nanjing, 210009
China
The Cancer Hospital Affiliated to Guangxi Medical University
Nanning, 530021
China
Fudan Cancer Hospital
Shanghai, 200032
China
Shanghai East Hospital
Shanghai, 200120
China
Tongji Hospital, Tongji Medical College of HUST
Wuhan, 430030
China
Union Hospital Tongji Medical College of Huazhong University of Science and Technology
Wuhan, 430048
China
Wuhan University - Zhongnan Hospital
Wuhan, 430071
China
The First Affiliated Hospital of Xian Jiaotong University
Xi'an, 710061
China
Yibin Second People's Hospital
Yibin, 644609
China
Fakultni nemocnice Hradec Kralove
Hradec Králové, 500 05
Czechia
University Hospital Olomouc
Olomouc, 779 00
Czechia
University Hospital Ostrava
Ostrava, 708 00
Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, 100 00
Czechia
Motol University Hospital
Prague, 150 06
Czechia
Krajska nemocnice T. Bati, a.s.
Zlín, 760 01
Czechia
Institut Sainte Catherine
Avignon, 84918
France
Clinique Victor Hugo
Le Mans, 72000
France
Centre Oscar Lambret
Lille, 59000
France
Assistance Publique Hopitaux de Marseille (AP-HM) - Hopital
Marseille, 13005
France
Institut Curie
Paris, 75005
France
Assistance Publique - Hopitaux de Paris
Paris, 75012
France
Centre Henri Becquerel
Rouen, 76000
France
Institut Gustave Roussy
Villejuif, 94800
France
Universitatsklinikum Bonn
Bonn, 53127
Germany
Universitaetsklinikum Essen
Essen, 45147
Germany
Universitaetsklinikum Frankfurt
Frankfurt, 60596
Germany
Universitaetsklinikum Giessen und Marburg GmbH
Giessen, 35392
Germany
Klinikum Region Hannover Klinikum Siloah
Hanover,
Germany
Universitaetsklinikum Leipzig
Leipzig, 04103
Germany
Universitaetsklinikum Regensburg
Regensburg, 93053
Germany
Universitätsmedizin Rostock Zentrum für Innere MedizinKlinik III
Rostock, 18057
Germany
Universitaetsklinikum Ulm
Ulm, 89075
Germany
Semmelweis Egyetem
Budapest, 1083
Hungary
Orszagos Onkologiai Intezet
Budapest, 1122
Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032
Hungary
Gyor Moson Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Győr, 9024
Hungary
Pecsi Tudomanyegyetem Klinikai Kozpont
Pécs, 7624
Hungary
Nograd Varmegyei Szent Lazar Korhaz
Salgótarján, 3100
Hungary
Apollo Speciality Hospital, Chennai
Chennai, 600035
India
Bhagwan Mahaveer Cancer Hospital & Research Centre
Jaipur, 302017
India
Chittaranjan National Cancer Institute (CNCI)
Kolkata, 700026
India
HealthCare Global HCG Manavata Cancer Centre
Nashik, 422002
India
All India Institute of Medical Sciences
New Delhi, 110029
India
Kailash Cancer Hospital and Research Centre
Vadodara, 391760
India
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133
Italy
European Institute of Oncology
Milan, 20141
Italy
Fondazione G Pascale Istituto Nazionale Tumori IRCCS
Naples, 80131
Italy
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
Palermo, 90127
Italy
IRCCS Policlinico San Matteo, Università degli studi di Pavi
Pavia, 27100
Italy
AOU Policlinico Umberto I
Roma, 00161
Italy
Istituto Clinico Humanitas
Rozzano, 20089
Italy
Kansai Medical University Hospital
Hirakata, 573 1191
Japan
National Cancer Center Hospital East
Kashiwa, 277 8577
Japan
Aichi Cancer Center
Nagoya, 464-8681
Japan
Hokkaido University Hospital
Sapporo, 060 8648
Japan
Tokyo Medical University Hospital
Shinjuku, 160 0023
Japan
Shizuoka Cancer Center
Sunto Gun, 411 8777
Japan
National Cancer Center Hospital
Tokyo, 104 0045
Japan
The Cancer Institute Hospital of JFCR
Tokyo, 135 8550
Japan
CO de Chihuahua
Chihuahua City, 31217
Mexico
Act. Basada en la Inv. Del Ca
Guadalajara, 44680
Mexico
P. y S. Oncologicos Acacias
Mexico City, 03240
Mexico
Gefarma Atrys
Mexico City, 11510
Mexico
Cuidados Oncologicos
Querétaro, 76000
Mexico
Find My Cancer Cen de Inv Clin
Tijuana, 22010
Mexico
Amsterdam UMC Cancer Center Amsterdam location VUmc
Amsterdam, 1081 HV
Netherlands
Universitair Medisch Centrum Groningen
Groningen, 9713 GZ
Netherlands
Maastricht UMC
Maastricht, 6229 HX
Netherlands
Uniwersyteckie Centrum Kliniczne
Gdansk, 80 214
Poland
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz w Gliwicach
Gliwice, 44-102
Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi
Lodz, 93-513
Poland
Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli
Lublin, 20-090
Poland
Wielkopolskie Centrum Onkologii im. Marii Sklodowskiej-Curie
Poznan, 61-866
Poland
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
Warsaw, 02-781
Poland
Uls Santa Maria - Hosp. Santa Maria
Lisbon, 1649 028
Portugal
Hosp. Cuf Descobertas
Lisbon, 1998-018
Portugal
Hospital de Portimao-Centro Hospitalar do Barlavento Algarvio
Portimão, 8500-338
Portugal
Instituto Portugues de Oncologia
Porto, 4200-072
Portugal
Uls Gaia Espinho
Vila Nova de Gaia, 4434 502
Portugal
Spitalul Clinic Coltea
Bucharest, 030167
Romania
Cardiomed
Cluj-Napoca, 400015
Romania
Institutul Oncologic 'Prof Dr. Ion Chiricuta' Cluj-Napoca
Cluj-Napoca, 400015
Romania
Clinica de Oncologie Sf Nectarie
Craiova, 200542
Romania
Institutul Regional de Oncologie Iasi
Iași, 700483
Romania
Oncocenter Oncologie Clinica SRL
Timișoara, 300166
Romania
Seoul National University Hospital
Seoul, 03080
South Korea
Severance Hospital Yonsei University Health System
Seoul, 03722
South Korea
Asan Medical Center
Seoul, 05505
South Korea
Samsung Medical Center
Seoul, 06351
South Korea
Hosp Univ Vall D Hebron
Barcelona, 08035
Spain
Hosp. Gral. Univ. Gregorio Maranon
Madrid, 28007
Spain
Hospital Clinico San Carlos
Madrid, 28040
Spain
Hosp. Univ. 12 de Octubre
Madrid, 28041
Spain
Complejo Hosp de Navarra - Hosp de Navarra
Pamplona, 31008
Spain
Hosp. Clinico Univ. de Santiago
Santiago de Compostela, 15706
Spain
Hosp. Gral. Univ. Valencia
Valencia, 46014
Spain
Hosp. Univ. Miguel Servet
Zaragoza, 50009
Spain
Changhua Christian Hospital
Changhua, 500
Taiwan
Kaohsiung Medical University Chung Ho Memorial Hospital
Kaohsiung City, 80756
Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 833
Taiwan
China Medical University Hospital
Taichung, 404
Taiwan
National Cheng Kung University Hospital
Tainan, 704
Taiwan
National Taiwan University Hospital
Taipei, 100
Taiwan
Taipei Veterans General Hospital
Taipei, 112
Taiwan
Addenbrooke's Hospital
Cambridge, CB2 0QQ
United Kingdom
Castle Hill Hospital
Cottingham, HU16 5JQ
United Kingdom
Western General Hospital
Edinburgh, EH4 2XU
United Kingdom
Guy's and St Thomas' NHS Foundation Trust
Greater London, SE1 9RT
United Kingdom
Royal Surrey County Hospital NHS Trust
Guildford, GU2 7XX
United Kingdom
St Bartholomew's Hospital
London, EC1A 7BE
United Kingdom
Royal Marsden Hospital Chelsea
London, SW3 6JJ
United Kingdom
The Clatterbridge Cancer Centre
Metropolitan Borough of Wirral, CH63 4JY
United Kingdom
Mount Vernon Cancer Centre
Northwood, HA6 2RN
United Kingdom
Nottingham City Hospital
Nottingham, NG5 1PB
United Kingdom
The Royal Marsden NHS Trust Sutton
Sutton, SM2 5PT
United Kingdom