AzTrials
AzTrials

Squamous Cell Carcinoma of Head and NeckPhase 3OrigAMI-5NCT07276399

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 study testing Amivantamab, Pembrolizumab and Carboplatin in people with Squamous Cell Carcinoma of Head and Neck, run by Janssen Research & Development, LLC at 205 sites in 22 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Squamous Cell Carcinoma of Head and Neck
What is being tested?
Amivantamab, Pembrolizumab and Carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
205 sitesin 22 countries
Study dates
3 Dec 2025to 18 Jul 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

205 sites in 22 countries. Contact the study team or a site near you to ask about taking part.

Study Contact contact

844-434-4210

Participate-In-This-Study1@its.jnj.com

205 sites in 22 countries

United States51 sites, 51 recruiting

  • Trinity Health St Joseph Mercy Ann Arbor

    Ann Arbor, Michigan, 48197

    Recruiting

  • Emory University

    Atlanta, Georgia, 30308

    Recruiting

  • University of Maryland Greenebaum Cancer Center

    Baltimore, Maryland, 21201

    Recruiting

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

    Recruiting

  • Ironwood Cancer and Research Center

    Chandler, Arizona, 85224

    Recruiting

  • University of Virginia

    Charlottesville, Virginia, 22908

    Recruiting

  • Rush University Medical Center Rush University Cancer Center Chicago

    Chicago, Illinois, 60607

    Recruiting

  • The University of Chicago Medical Center (UCMC)

    Chicago, Illinois, 60637

    Recruiting

  • University of Cincinnati

    Cincinnati, Ohio, 45219

    Recruiting

  • Ohio State University

    Columbus, Ohio, 43210

    Recruiting

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

    Recruiting

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201 2013

    Recruiting

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

    Recruiting

  • Florida Cancer Specialists South

    Fort Myers, Florida, 33901

    Recruiting

  • Texas Oncology - San Antonio

    Fredericksburg, Texas, 78624

    Recruiting

  • Providence St Jude Medical Center

    Fullerton, California, 92835

    Recruiting

  • Hartford Hospital

    Hartford, Connecticut, 06102

    Recruiting

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

    Recruiting

  • MD Anderson Cancer Center

    Houston, Texas, 77030

    Recruiting

  • Tennessee Cancer Specialists

    Knoxville, Tennessee, 37909

    Recruiting

  • Scripps Health

    La Jolla, California, 92037

    Recruiting

  • University of Kentucky Medical Center

    Lexington, Kentucky, 40536

    Recruiting

  • NHO Revive Research Institute, LLC

    Lincoln, Nebraska, 68506

    Recruiting

  • Valkyrie Clinical Trials

    Los Angeles, California, 90067

    Recruiting

  • University of California, Los Angeles UCLA

    Los Angeles, California, 90095

    Recruiting

  • Central Georgia Cancer Care

    Macon, Georgia, 31210

    Recruiting

  • University of Miami Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136

    Recruiting

  • Laura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long Island

    Mineola, New York, 11501

    Recruiting

  • Valkyrie Clinical Trials Murrieta

    Murrieta, California, 92562

    Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

    Recruiting

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

    Recruiting

  • Yale Cancer Center

    New Haven, Connecticut, 06510

    Recruiting

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone Health

    New York, New York, 10016

    Recruiting

  • Cancer Care Specialists of Central Illinois

    O'Fallon, Illinois, 62269

    Recruiting

  • AdventHealth Medical Group Oncology and Hematology at Orlando

    Orlando, Florida, 32804

    Recruiting

  • University of Pennsylvania Perelman Center for Advanced Medicine

    Philadelphia, Pennsylvania, 19106

    Recruiting

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

    Recruiting

  • Oregon Health And Science University

    Portland, Oregon, 97239

    Recruiting

  • University Of California - Davis

    Sacramento, California, 95817

    Recruiting

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

    Recruiting

  • UCSF Medical Center at Mission Bay

    San Francisco, California, 94158

    Recruiting

  • Washington University School Of Medicine

    St Louis, Missouri, 63108

    Recruiting

  • Florida Cancer Specialists North Region

    St. Petersburg, Florida, 33701-4553

    Recruiting

  • Stanford University Medical Center

    Stanford, California, 94304

    Recruiting

  • Montefiore Medical Center

    The Bronx, New York, 10461

    Recruiting

  • Bronx Veterans Affairs Medical Center

    The Bronx, New York, 10468

    Recruiting

  • University of Arizona Cancer Center

    Tucson, Arizona, 85719

    Recruiting

  • UT Health East Texas HOPE Cancer Center

    Tyler, Texas, 75701

    Recruiting

  • Texas Oncology-Central South

    Waco, Texas, 76712

    Recruiting

  • Florida Cancer Specialists East

    West Palm Beach, Florida, 33401-3406

    Recruiting

  • Carolina Cancer Research Center

    Wilson, North Carolina, 27893

    Recruiting

Other trials in United States

China25 sites, 25 recruiting

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, 100021

    Recruiting

  • Tongren Hospital Outpatient Bldg

    Beijing, 100051

    Recruiting

  • Beijing Cancer Hospital

    Beijing, 100142

    Recruiting

  • The Affiliated Hospital of Bengbu Medical College

    Bengbu, 233099

    Recruiting

  • The second Xiangya Hospital of Central South University

    Changsha, 410011

    Recruiting

  • Hunan Cancer hospital

    Changsha, 410013

    Recruiting

  • Sichuan Cancer Hospital

    Chengdu, 610041

    Recruiting

  • West China Hospital Sichuan University

    Chengdu, 610041

    Recruiting

  • Sichuan Provincial Peoples Hospital

    Chengdu, 610072

    Recruiting

  • Chongqing Cancer Hospital

    Chongqing, 400015

    Recruiting

  • Dongguan People s Hospital

    Dongguan, 523063

    Recruiting

  • Sun Yat-sen University Cancer Hospital

    Guangzhou, 510060

    Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, 310022

    Recruiting

  • The Affiliated Cancer Hospital of Shandong First Medical University

    Jinan, 250117

    Recruiting

  • Yunnan Cancer Hospital

    Kunming, 650100

    Recruiting

  • Linyi Cancer Hospital

    Linyi, 276002

    Recruiting

  • Nanjing Drum Tower Hospital

    Nanjing, 210009

    Recruiting

  • The Cancer Hospital Affiliated to Guangxi Medical University

    Nanning, 530021

    Recruiting

  • Fudan Cancer Hospital

    Shanghai, 200032

    Recruiting

  • Shanghai East Hospital

    Shanghai, 200120

    Recruiting

  • Tongji Hospital, Tongji Medical College of HUST

    Wuhan, 430030

    Recruiting

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

    Wuhan, 430048

    Recruiting

  • Wuhan University - Zhongnan Hospital

    Wuhan, 430071

    Recruiting

  • The First Affiliated Hospital of Xian Jiaotong University

    Xi'an, 710061

    Recruiting

  • Yibin Second People's Hospital

    Yibin, 644609

    Recruiting

Other trials in China

United Kingdom11 sites, 11 recruiting

  • Addenbrooke's Hospital

    Cambridge, CB2 0QQ

    Recruiting

  • Castle Hill Hospital

    Cottingham, HU16 5JQ

    Recruiting

  • Western General Hospital

    Edinburgh, EH4 2XU

    Recruiting

  • Guy's and St Thomas' NHS Foundation Trust

    Greater London, SE1 9RT

    Recruiting

  • Royal Surrey County Hospital NHS Trust

    Guildford, GU2 7XX

    Recruiting

  • St Bartholomew's Hospital

    London, EC1A 7BE

    Recruiting

  • Royal Marsden Hospital Chelsea

    London, SW3 6JJ

    Recruiting

  • The Clatterbridge Cancer Centre

    Metropolitan Borough of Wirral, CH63 4JY

    Recruiting

  • Mount Vernon Cancer Centre

    Northwood, HA6 2RN

    Recruiting

  • Nottingham City Hospital

    Nottingham, NG5 1PB

    Recruiting

  • The Royal Marsden NHS Trust Sutton

    Sutton, SM2 5PT

    Recruiting

Other trials in United Kingdom

France9 sites, 9 recruiting

  • Institut Sainte Catherine

    Avignon, 84918

    Recruiting

  • Clinique Victor Hugo

    Le Mans, 72000

    Recruiting

  • Centre Oscar Lambret

    Lille, 59000

    Recruiting

  • Assistance Publique Hopitaux de Marseille (AP-HM) - Hopital

    Marseille, 13005

    Recruiting

  • Institut Curie

    Paris, 75005

    Recruiting

  • Assistance Publique - Hopitaux de Paris

    Paris, 75012

    Recruiting

  • Centre Henri Becquerel

    Rouen, 76000

    Recruiting

  • I.C.O. Rene Gauducheau

    Saint-Herblain, 44805

    Recruiting

  • Institut Gustave Roussy

    Villejuif, 94800

    Recruiting

Other trials in France

Germany9 sites, 9 recruiting

  • Universitatsklinikum Bonn

    Bonn, 53127

    Recruiting

  • Universitaetsklinikum Essen

    Essen, 45147

    Recruiting

  • Universitaetsklinikum Frankfurt

    Frankfurt, 60596

    Recruiting

  • Universitaetsklinikum Giessen und Marburg GmbH

    Giessen, 35392

    Recruiting

  • Klinikum Region Hannover Klinikum Siloah

    Hanover

    Recruiting

  • Universitaetsklinikum Leipzig

    Leipzig, 04103

    Recruiting

  • Universitaetsklinikum Regensburg

    Regensburg, 93053

    Recruiting

  • Universitätsmedizin Rostock Zentrum für Innere MedizinKlinik III

    Rostock, 18057

    Recruiting

  • Universitaetsklinikum Ulm

    Ulm, 89075

    Recruiting

Other trials in Germany

Spain9 sites, 9 recruiting

  • Hosp Univ Vall D Hebron

    Barcelona, 08035

    Recruiting

  • Inst. Cat. Doncologia-H Duran I Reynals

    L'Hospitalet de Llobregat, 08908

    Recruiting

  • Hosp. Gral. Univ. Gregorio Maranon

    Madrid, 28007

    Recruiting

  • Hospital Clinico San Carlos

    Madrid, 28040

    Recruiting

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041

    Recruiting

  • Complejo Hosp de Navarra - Hosp de Navarra

    Pamplona, 31008

    Recruiting

  • Hosp. Clinico Univ. de Santiago

    Santiago de Compostela, 15706

    Recruiting

  • Hosp. Gral. Univ. Valencia

    Valencia, 46014

    Recruiting

  • Hosp. Univ. Miguel Servet

    Zaragoza, 50009

    Recruiting

Other trials in Spain

Japan8 sites, 8 recruiting

  • Kansai Medical University Hospital

    Hirakata, 573 1191

    Recruiting

  • National Cancer Center Hospital East

    Kashiwa, 277 8577

    Recruiting

  • Aichi Cancer Center

    Nagoya, 464-8681

    Recruiting

  • Hokkaido University Hospital

    Sapporo, 060 8648

    Recruiting

  • Tokyo Medical University Hospital

    Shinjuku, 160 0023

    Recruiting

  • Shizuoka Cancer Center

    Sunto Gun, 411 8777

    Recruiting

  • National Cancer Center Hospital

    Tokyo, 104 0045

    Recruiting

  • The Cancer Institute Hospital of JFCR

    Tokyo, 135 8550

    Recruiting

Other trials in Japan

Italy7 sites, 7 recruiting

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133

    Recruiting

  • European Institute of Oncology

    Milan, 20141

    Recruiting

  • Fondazione G Pascale Istituto Nazionale Tumori IRCCS

    Naples, 80131

    Recruiting

  • Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

    Palermo, 90127

    Recruiting

  • IRCCS Policlinico San Matteo, Università degli studi di Pavi

    Pavia, 27100

    Recruiting

  • AOU Policlinico Umberto I

    Roma, 00161

    Recruiting

  • Istituto Clinico Humanitas

    Rozzano, 20089

    Recruiting

Other trials in Italy

Taiwan7 sites, 7 recruiting

  • Changhua Christian Hospital

    Changhua, 500

    Recruiting

  • Kaohsiung Medical University Chung Ho Memorial Hospital

    Kaohsiung City, 80756

    Recruiting

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 833

    Recruiting

  • China Medical University Hospital

    Taichung, 404

    Recruiting

  • National Cheng Kung University Hospital

    Tainan, 704

    Recruiting

  • National Taiwan University Hospital

    Taipei, 100

    Recruiting

  • Taipei Veterans General Hospital

    Taipei, 112

    Recruiting

Other trials in Taiwan

Brazil6 sites, 6 recruiting

  • Fundacao Doutor Amaral Carvalho

    Jaú, 17210 080

    Recruiting

  • Liga Norte Riograndense Contra O Cancer

    Natal, 59062 000

    Recruiting

  • Irmandade Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, 90050 170

    Recruiting

  • Funfarme Sjrp

    São José do Rio Preto, 15090-000

    Recruiting

  • Hospital Alemao Oswaldo Cruz

    São Paulo, 01323 903

    Recruiting

  • Associacao Feminina de Educacao e Combate ao Cancer Hospital Santa Rita de Cassia

    Vitória, 29043 260

    Recruiting

Other trials in Brazil

Czechia6 sites, 6 recruiting

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 500 05

    Recruiting

  • University Hospital Olomouc

    Olomouc, 779 00

    Recruiting

  • University Hospital Ostrava

    Ostrava, 708 00

    Recruiting

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, 100 00

    Recruiting

  • Motol University Hospital

    Prague, 150 06

    Recruiting

  • Krajska nemocnice T. Bati, a.s.

    Zlín, 760 01

    Recruiting

Other trials in Czechia

Hungary6 sites, 6 recruiting

  • Semmelweis Egyetem

    Budapest, 1083

    Recruiting

  • Orszagos Onkologiai Intezet

    Budapest, 1122

    Recruiting

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032

    Recruiting

  • Gyor Moson Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz

    Győr, 9024

    Recruiting

  • Pecsi Tudomanyegyetem Klinikai Kozpont

    Pécs, 7624

    Recruiting

  • Nograd Varmegyei Szent Lazar Korhaz

    Salgótarján, 3100

    Recruiting

Other trials in Hungary

India6 sites, 6 recruiting

  • Apollo Speciality Hospital, Chennai

    Chennai, 600035

    Recruiting

  • Bhagwan Mahaveer Cancer Hospital & Research Centre

    Jaipur, 302017

    Recruiting

  • Chittaranjan National Cancer Institute (CNCI)

    Kolkata, 700026

    Recruiting

  • HealthCare Global HCG Manavata Cancer Centre

    Nashik, 422002

    Recruiting

  • All India Institute of Medical Sciences

    New Delhi, 110029

    Recruiting

  • Kailash Cancer Hospital and Research Centre

    Vadodara, 391760

    Recruiting

Other trials in India

Mexico6 sites, 6 recruiting

  • CO de Chihuahua

    Chihuahua City, 31217

    Recruiting

  • Act. Basada en la Inv. Del Ca

    Guadalajara, 44680

    Recruiting

  • P. y S. Oncologicos Acacias

    Mexico City, 03240

    Recruiting

  • Gefarma Atrys

    Mexico City, 11510

    Recruiting

  • Cuidados Oncologicos

    Querétaro, 76000

    Recruiting

  • Find My Cancer Cen de Inv Clin

    Tijuana, 22010

    Recruiting

Other trials in Mexico

Poland6 sites, 6 recruiting

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80 214

    Recruiting

  • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz w Gliwicach

    Gliwice, 44-102

    Recruiting

  • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi

    Lodz, 93-513

    Recruiting

  • Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli

    Lublin, 20-090

    Recruiting

  • Wielkopolskie Centrum Onkologii im. Marii Sklodowskiej-Curie

    Poznan, 61-866

    Recruiting

  • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

    Warsaw, 02-781

    Recruiting

Other trials in Poland

Romania6 sites, 6 recruiting

  • Spitalul Clinic Coltea

    Bucharest, 030167

    Recruiting

  • Cardiomed

    Cluj-Napoca, 400015

    Recruiting

  • Institutul Oncologic 'Prof Dr. Ion Chiricuta' Cluj-Napoca

    Cluj-Napoca, 400015

    Recruiting

  • Clinica de Oncologie Sf Nectarie

    Craiova, 200542

    Recruiting

  • Institutul Regional de Oncologie Iasi

    Iași, 700483

    Recruiting

  • Oncocenter Oncologie Clinica SRL

    Timișoara, 300166

    Recruiting

Other trials in Romania

Australia5 sites, 5 recruiting

  • Monash Medical Centre

    Clayton, 3168

    Recruiting

  • Liverpool Hospital

    Liverpool, 2170

    Recruiting

  • Peter MacCallum Cancer Centre

    Melbourne, 3000

    Recruiting

  • St John of God Hospital Murdoch

    Murdoch, 6150

    Recruiting

  • GenesisCare

    St Leonards, 2065

    Recruiting

Other trials in Australia

Austria5 sites, 5 recruiting

  • Tirol Kliniken MedUni Innsbruck

    Innsbruck, 6020

    Recruiting

  • Burgenlaendische Krankenanstalten Gesellschaft M B H Klinik Oberwart

    Oberwart, A-7400

    Recruiting

  • Universitaetsklinikum Salzburg Landeskrankenhaus

    Salzburg, A-5020

    Recruiting

  • University Hospital St. Poelten

    Sankt Pölten, A-3100

    Recruiting

  • Medical University Vienna MUV

    Vienna, A 1090

    Recruiting

Other trials in Austria

Belgium5 sites, 5 recruiting

  • UZ Antwerpen

    Edegem, 2650

    Recruiting

  • Chu Helora Hospital La Louviere Site Jolimont

    Haine-Saint-Paul, 7100

    Recruiting

  • Universitair Ziekenhuis Leuven

    Leuven, 3000

    Recruiting

  • Vitaz

    Sint-Niklaas, 9100

    Recruiting

  • Institut Roi Albert II

    Woluwe-Saint-Lambert, 1200

    Recruiting

Other trials in Belgium

Portugal5 sites, 5 recruiting

  • Uls Santa Maria - Hosp. Santa Maria

    Lisbon, 1649 028

    Recruiting

  • Hosp. Cuf Descobertas

    Lisbon, 1998-018

    Recruiting

  • Hospital de Portimao-Centro Hospitalar do Barlavento Algarvio

    Portimão, 8500-338

    Recruiting

  • Instituto Portugues de Oncologia

    Porto, 4200-072

    Recruiting

  • Uls Gaia Espinho

    Vila Nova de Gaia, 4434 502

    Recruiting

Other trials in Portugal

South Korea4 sites, 4 recruiting

  • Seoul National University Hospital

    Seoul, 03080

    Recruiting

  • Severance Hospital Yonsei University Health System

    Seoul, 03722

    Recruiting

  • Asan Medical Center

    Seoul, 05505

    Recruiting

  • Samsung Medical Center

    Seoul, 06351

    Recruiting

Other trials in South Korea

Netherlands3 sites, 3 recruiting

  • Amsterdam UMC Cancer Center Amsterdam location VUmc

    Amsterdam, 1081 HV

    Recruiting

  • Universitair Medisch Centrum Groningen

    Groningen, 9713 GZ

    Recruiting

  • Maastricht UMC

    Maastricht, 6229 HX

    Recruiting

Other trials in Netherlands

About this study

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

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.

Being tested
Amivantamab, Pembrolizumab, Carboplatin, 5-Flurouracil, Cisplatin
Medical subject headings
Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AmivantamabBiological

    Also called JNJ-61186372, RYBREVANT

    Amivantamab will be administered.

  • PembrolizumabBiological

    Pembrolizumab will be administered.

  • CarboplatinDrug

    Carboplatin will be administered.

  • 5-FlurouracilDrug

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

  • CisplatinDrug

    Cisplatin will be administered.

Study groups in NCT07276399
Study groupRoleWhat they receive
Arm A: Pembrolizumab, Amivantamab, CarboplatinExperimentalParticipants will receive pembrolizumab, amivantamab and carboplatin.
Receives: Biological: Amivantamab; Biological: Pembrolizumab; Drug: Carboplatin
Arm B: Pembrolizumab, 5-Flurouracil (5-FU), Carboplatin or CisplatinActive comparatorParticipants will receive pembrolizumab, 5-FU and carboplatin or cisplatin (platinum therapy).
Receives: Biological: Pembrolizumab; Drug: Carboplatin; Drug: 5-Flurouracil; Drug: Cisplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

    OS is defined as time from the date of randomization to the date of death due to any cause.

    Measured: Up to approximately 3 years 7 months

  2. Objective Response Rate (ORR) Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Blinded Independent Central Review (BICR)

    ORR is defined as the percentage of randomized participants achieving a confirmed best overall response (BOR) of partial response (PR) or complete response (CR) by BICR using RECIST version 1.1 .

    Measured: Up to approximately 3 years 7 months

Secondary outcomes (12)

  1. Progression-Free Survival (PFS) Using RECIST Version 1.1, as Assessed by BICR

    PFS is defined as the time from randomization until the date of objective disease progression or death (due to any cause), whichever comes first, based on BICR assessment using RECIST v1.1, regardless of treatment discontinuation or start of subsequent anticancer therapy.

    Measured: Up to approximately 3 years 7 months

  2. Duration of Response (DOR) As Assessed by BICR

    DOR as assessed by BICR is defined as the time from the date of first documented response (CR or PR) until the date of documented progression or death, whichever comes first, for participants who have PR or CR as best response.

    Measured: Up to approximately 3 years 7 months

  3. ORR as Assessed by Investigator

    ORR as assessed by the investigator is defined as the percentage of randomized participants achieving CR or PR, as defined by investigator assessment using RECIST v1.1 criteria.

    Measured: Up to approximately 3 years 7 months

  4. Number of Participants with Treatment-Emergent Adverse Events (TEAEs)

    TEAE is defined as any new or worsening adverse event (AE) occurring at or after the initial administration of study treatment through the day of last dose plus 30 days or prior to the start of subsequent anticancer therapy, whichever is earlier, or any follow-up AE with onset date and time beyond 30 days after the last dose of study treatment but prior to the start of subsequent therapy or any AE that is considered treatment-related regardless of the start date of the event.

    Measured: Up to approximately 3 years 7 months

  5. Number of Participants with Laboratory Abnormalities

    Blood samples will be collected to determine the laboratory (serum chemistry and hematology) abnormalities.

    Measured: Up to approximately 3 years 7 months

  6. Percentage of Participants with Improved or Stable Symptoms Compared to Baseline as Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Module 43 (EORTC QLQ-HN43) Symptom Scale Score

    EORTC QLQ-HN43, is a self-administered, 43-item questionnaire measuring the health-related quality of life (HRQoL) of participants with head and neck cancer. EORTC QLQ-HN43 includes 19 scales (anxiety, body image, coughing, dry mouth and sticky saliva, neurological problems, opening mouth, pain in the mouth, social contact, problems with senses, shoulder problems, skin problems, swelling in the neck, social eating, speech, swallowing, sexuality, problems with teeth, weight loss, and problems with wound healing). Responses to items are rated on a 4-point Likert response scale ranging from 1 "Not at all" to 4 "Very much". Higher scores indicate worse health outcomes.

    Measured: Baseline, up to approximately 3 years 7 months

  7. Percentage of Participants with Improved or Stable Symptoms Compared to Baseline as Measured by EORTC QLQ-Core (C) 30 Symptom Scale Score

    EORTC QLQ-C30, is a self-administered, 30-item questionnaire measuring the HRQoL of participants with cancer. EORTC QLQ-C30 includes 3 symptom scales (fatigue, pain, and nausea and vomiting), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Responses to items 1-28 are rated on a 4-point Likert response scale ranging from 1 "Not at all" to 4 "Very much". Two global health status items are rated on a 7-point numeric rating scale from 1 "Very Poor" to 7 "Excellent." Higher scores indicate greater functioning, better global health status, or more severe symptoms.

    Measured: Baseline, up to approximately 3 years 7 months

  8. Change from Baseline in Functioning HRQoL, as Measured by Functioning Scales of the EORTC QLQ-C30

    EORTC QLQ-C30, is a self-administered, 30-item questionnaire measuring the HRQoL of participants with cancer. EORTC QLQ-C30 includes 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea and vomiting), a global health status / quality of life scale, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Responses to items 1-28 are rated on a 4-point Likert response scale ranging from 1 "Not at all" to 4 "Very much". Two global health status items are rated on a 7-point numeric rating scale from 1 "Very Poor" to 7 "Excellent." Higher scores indicate greater functioning, better global health status, or more severe symptoms.

    Measured: Baseline, up to approximately 3 years 7 months

  9. Change from Baseline in Overall HRQoL, as Measured by Global Health Scales of the EORTC QLQ-C30

    EORTC QLQ-C30, is a self-administered, 30-item questionnaire measuring the HRQoL of participants with cancer. EORTC QLQ-C30 includes 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea and vomiting), a global health status / quality of life scale, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Responses to items 1-28 are rated on a 4-point Likert response scale ranging from 1 "Not at all" to 4 "Very much". Two global health status items are rated on a 7-point numeric rating scale from 1 "Very Poor" to 7 "Excellent." Higher scores indicate greater functioning, better global health status, or more severe symptoms.

    Measured: Baseline, up to approximately 3 years 7 months

  10. Differences Between Treatment Groups (Arms A and B) for EORTC Quality of Life (QLG) Item Library-46 (IL-46) Tolerability Scale Scores

    EORTC IL46 is a single item used to measure the overall impact of treatment side effects. Responses are rated on a 4-point Likert response scale ranging from 1 "Not at all" to 4 "Very much." Higher score indicates more impact of treatment side-effects.

    Measured: Up to approximately 3 years 7 months

  11. Serum Concentration of Amivantamab

    Serum concentrations of amivantamab will be analyzed.

    Measured: Up to approximately 3 years 7 months

  12. Number of Participants with Serum Anti-Amivantamab Antibodies

    Participants who are positive to serum anti-amivantamab antibodies will be reported.

    Measured: Up to approximately 3 years 7 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2025
  2. Study start3 Dec 2025
  3. Primary completion18 Jun 2029 (estimated)
  4. Study completion18 Jul 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07276399
Sponsor's protocol ID
61186372HNC3001
Other IDs
61186372HNC3001, 2025-521917-24-00, 2025
Acronym
OrigAMI-5
Status last verified
Nov 2026
First submitted
1 Dec 2025
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Amivantamab, Pembrolizumab and Carboplatin in people with Squamous Cell Carcinoma of Head and Neck, run by Janssen Research & Development, LLC at 205 sites in 22 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 205 sites in United States, China, United Kingdom, France, Germany and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Study Contact (844-434-4210, Participate-In-This-Study1@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: Up to approximately 3 years 7 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07276399.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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