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 (OrigAMI-5)

June 4, 2026 updated by: Janssen Research & Development, LLC

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

500

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A: Pembrolizumab, Amivantamab, Carboplatin
Participants will receive pembrolizumab, amivantamab and carboplatin.
Drug: Carboplatin
Carboplatin will be administered.
Biological: Pembrolizumab
Pembrolizumab will be administered.
Biological: Amivantamab
Amivantamab will be administered.
Other Names:
  • JNJ-61186372
  • RYBREVANT
Active Comparator: Arm B: Pembrolizumab, 5-Flurouracil (5-FU), Carboplatin or Cisplatin
Participants will receive pembrolizumab, 5-FU and carboplatin or cisplatin (platinum therapy).
Drug: Cisplatin
Cisplatin will be administered.
Drug: Carboplatin
Carboplatin will be administered.
Biological: Pembrolizumab
Pembrolizumab will be administered.
Drug: 5-Flurouracil
5-Flurouracil will be administered for over 4-day infusion period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Up to approximately 3 years 7 months
OS is defined as time from the date of randomization to the date of death due to any cause.
Up to approximately 3 years 7 months
Objective Response Rate (ORR) Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Blinded Independent Central Review (BICR)
Time Frame: Up to approximately 3 years 7 months
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 .
Up to approximately 3 years 7 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS) Using RECIST Version 1.1, as Assessed by BICR
Time Frame: Up to approximately 3 years 7 months
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.
Up to approximately 3 years 7 months
Duration of Response (DOR) As Assessed by BICR
Time Frame: Up to approximately 3 years 7 months
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.
Up to approximately 3 years 7 months
ORR as Assessed by Investigator
Time Frame: Up to approximately 3 years 7 months
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.
Up to approximately 3 years 7 months
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Time Frame: Up to approximately 3 years 7 months
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.
Up to approximately 3 years 7 months
Number of Participants with Laboratory Abnormalities
Time Frame: Up to approximately 3 years 7 months
Blood samples will be collected to determine the laboratory (serum chemistry and hematology) abnormalities.
Up to approximately 3 years 7 months
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
Time Frame: Baseline, up to approximately 3 years 7 months
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.
Baseline, up to approximately 3 years 7 months
Percentage of Participants with Improved or Stable Symptoms Compared to Baseline as Measured by EORTC QLQ-Core (C) 30 Symptom Scale Score
Time Frame: Baseline, up to approximately 3 years 7 months
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.
Baseline, up to approximately 3 years 7 months
Change from Baseline in Functioning HRQoL, as Measured by Functioning Scales of the EORTC QLQ-C30
Time Frame: Baseline, up to approximately 3 years 7 months
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.
Baseline, up to approximately 3 years 7 months
Change from Baseline in Overall HRQoL, as Measured by Global Health Scales of the EORTC QLQ-C30
Time Frame: Baseline, up to approximately 3 years 7 months
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.
Baseline, up to approximately 3 years 7 months
Differences Between Treatment Groups (Arms A and B) for EORTC Quality of Life (QLG) Item Library-46 (IL-46) Tolerability Scale Scores
Time Frame: Up to approximately 3 years 7 months
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.
Up to approximately 3 years 7 months
Serum Concentration of Amivantamab
Time Frame: Up to approximately 3 years 7 months
Serum concentrations of amivantamab will be analyzed.
Up to approximately 3 years 7 months
Number of Participants with Serum Anti-Amivantamab Antibodies
Time Frame: Up to approximately 3 years 7 months
Participants who are positive to serum anti-amivantamab antibodies will be reported.
Up to approximately 3 years 7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Research & Development, LLC

Investigators

  • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 3, 2025

Primary Completion (Estimated)

June 18, 2029

Study Completion (Estimated)

June 18, 2029

Study Registration Dates

First Submitted

December 1, 2025

First Submitted That Met QC Criteria

December 1, 2025

First Posted (Actual)

December 11, 2025

Study Record Updates

Last Update Posted (Actual)

June 5, 2026

Last Update Submitted That Met QC Criteria

June 4, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 61186372HNC3001 (Other Identifier: Janssen Research & Development, LLC)
  • 2025-521917-24-00 (Registry Identifier: EUCT number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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