RecruitingPhase 3NCT07276399

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

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

Sponsor

Janssen Research & Development, LLC

Enrollment

500 participants

Start Date

Dec 3, 2025

Study Type

INTERVENTIONAL

Conditions

Squamous Cell Carcinoma of Head and Neck

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether adding a drug called amivantamab to standard chemotherapy and immunotherapy improves outcomes for people with head and neck cancer (from the mouth, throat, or voice box) that has returned or spread and cannot be cured with local treatment. **You may be eligible if...** - You are 18 or older - You have confirmed squamous cell carcinoma of the head and neck (oral cavity, oropharynx, hypopharynx, or larynx) that has returned or spread - You have not yet received drug treatments for this advanced/recurrent disease - You are in good physical condition (ECOG 0 or 1) - Your disease is measurable on a scan **You may NOT be eligible if...** - You have an uncontrolled illness - You have untreated brain metastases - You have serious heart disease - Your organs or bone marrow are not functioning well enough - You have known allergies to amivantamab, pembrolizumab, carboplatin, cisplatin, or 5-FU - Your cancer is from the nasopharynx or of unknown primary location Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALAmivantamab

Amivantamab will be administered.

BIOLOGICALPembrolizumab

Pembrolizumab will be administered.

DRUGCarboplatin

Carboplatin will be administered.

DRUG5-Flurouracil

5-Flurouracil will be administered for over 4-day infusion period.

DRUGCisplatin

Cisplatin will be administered.

Locations(160)

Ironwood Cancer and Research Center

Chandler, Arizona, United States

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

Stanford University Medical Center

Stanford, California, United States

Hartford Hospital

Hartford, Connecticut, United States

Yale Cancer Center

New Haven, Connecticut, United States

Florida Cancer Specialists South

Fort Myers, Florida, United States

Florida Cancer Specialists North Region

St. Petersburg, Florida, United States

Florida Cancer Specialists East

West Palm Beach, Florida, 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

Ohio State University

Columbus, Ohio, 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

Beijing Cancer Hospital

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

Yunnan Cancer Hospital

Kunming, 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

Tongji Hospital, Tongji Medical College of HUST

Wuhan, China

Union Hospital Tongji Medical College of Huazhong University of Science and Technology

Wuhan, China

Wuhan University - Zhongnan Hospital

Wuhan, China

Yibin Second People's Hospital

Yibin, China

Fakultni nemocnice Hradec Kralove

Hradec Králové, Czechia

University Hospital Olomouc

Olomouc, 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 Giessen und Marburg GmbH

Giessen, Germany

Klinikum Region Hannover Klinikum Siloah

Hanover, Germany

Universitaetsklinikum Leipzig

Leipzig, Germany

Universitaetsklinikum Ulm

Ulm, Germany

Debreceni Egyetem Klinikai Kozpont

Debrecen, Hungary

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

IRCCS Policlinico San Matteo, Università degli studi di Pavi

Pavia, Italy

AOU Policlinico Umberto I

Roma, Italy

Istituto Clinico Humanitas

Rozzano, Italy

Kansai Medical University Hospital

Hirakata, Japan

National Cancer Center Hospital East

Kashiwa, Japan

Hokkaido University Hospital

Sapporo, Japan

Tokyo Medical University Hospital

Shinjuku, Japan

Shizuoka Cancer Center

Sunto Gun, 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

Hosp Univ Vall D Hebron

Barcelona, Spain

Hosp. Gral. Univ. Gregorio Maranon

Madrid, Spain

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

Addenbrooke's Hospital

Cambridge, United Kingdom

Castle Hill Hospital

Cottingham, United Kingdom

Western General Hospital

Edinburgh, 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 Chelsea

London, United Kingdom

The Clatterbridge Cancer Centre

Metropolitan Borough of Wirral, United Kingdom

Mount Vernon Cancer Centre

Northwood, United Kingdom

The Royal Marsden NHS Trust Sutton

Sutton, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT07276399

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