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NCT07276399PHASE3Recruiting

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

Janssen Research & Development, LLC

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

Inclusion criteria: * Be more than or equal to (\>=) 18 years of age (or the legal age of majority in the jurisdiction in which the study is taking place, whichever is greater) * Have histologically or cytologically confirmed recurrent/metastatic (R/M) HNSCC that is considered incurable by local therapies: a. eligible primary tumor locations are the oral cavity, oropharynx, hypopharynx, or larynx; b. Must not have a primary tumor site of nasopharynx or primary tumor of unknown location; c. Must have documented local testing results per local regulations; d. Human papillomavirus (HPV) status must be known for participants with primary tumor location in oropharynx via p16 test, HPV DNA test, or high-risk HPV in situ hybridization (ISH). Any known p16, HPV DNA, or high-risk HPV ISH status of tumor must be negative * Be treatment-naive for systemic therapy in the R/M setting * Have an ECOG performance status of 0 or 1 * Have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v).1.1 Exclusion criteria: * Have an uncontrolled illness * Have untreated brain metastases or history of known presence of leptomeningeal disease * Have a history of clinically significant cardiovascular disease * Inadequate organ or bone marrow function * Known allergies, hypersensitivity, contraindications, or intolerance to excipients of: Amivantamab, Pembrolizumab, Carboplatin, Cisplatin, 5-FU and Hyaluronidase

Interventions

BIOLOGICAL

Amivantamab

BIOLOGICAL

Pembrolizumab

DRUG

Carboplatin

DRUG

5-Flurouracil

DRUG

Cisplatin

Interested in This Trial?

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Conditions

Squamous Cell Carcinoma of Head and Neck

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