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
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
2 other identifiers
interventional
500
20 countries
158
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2025
Typical duration for phase_3
158 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 1, 2025
CompletedStudy Start
First participant enrolled
December 3, 2025
CompletedFirst Posted
Study publicly available on registry
December 11, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 18, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 18, 2029
April 13, 2026
April 1, 2026
3.5 years
December 1, 2025
April 9, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Overall Survival (OS)
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)
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 Outcomes (12)
Progression-Free Survival (PFS) Using RECIST Version 1.1, as Assessed by BICR
Up to approximately 3 years 7 months
Duration of Response (DOR) As Assessed by BICR
Up to approximately 3 years 7 months
ORR as Assessed by Investigator
Up to approximately 3 years 7 months
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Up to approximately 3 years 7 months
Number of Participants with Laboratory Abnormalities
Up to approximately 3 years 7 months
- +7 more secondary outcomes
Study Arms (2)
Arm A: Pembrolizumab, Amivantamab, Carboplatin
EXPERIMENTALParticipants will receive pembrolizumab, amivantamab and carboplatin.
Arm B: Pembrolizumab, 5-Flurouracil (5-FU), Carboplatin or Cisplatin
ACTIVE COMPARATORParticipants will receive pembrolizumab, 5-FU and carboplatin or cisplatin (platinum therapy).
Interventions
Cisplatin will be administered.
Amivantamab will be administered.
Pembrolizumab will be administered.
Carboplatin will be administered.
5-Flurouracil will be administered for over 4-day infusion period.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (160)
Ironwood Cancer and Research Center
Chandler, Arizona, 85224, United States
Providence St Jude Medical Center
Fullerton, California, 92835, United States
Valkyrie Clinical Trials
Los Angeles, California, 90067, United States
Valkyrie Clinical Trials Murrieta
Murrieta, California, 92562, 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
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
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
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
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
Texas Oncology - San Antonio
Fredericksburg, Texas, 78624, United States
Texas Oncology-Central South
Waco, Texas, 76712, United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
Virginia Cancer Specialists
Arlington, Virginia, 22201, United States
Monash Medical Centre
Clayton, 3168, Australia
Peter MacCallum Cancer Centre
Melbourne, 3000, Australia
St John of God Hospital Murdoch
Murdoch, 6150, Australia
GenesisCare
St Leonards, 2065, Australia
Universitaetsklinikum Salzburg Landeskrankenhaus
Salzburg, A-5020, Austria
University Hospital St. Poelten
Sankt Pölten, A-3100, 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
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
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
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
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
Universitaetsklinikum Giessen und Marburg GmbH
Giessen, 35392, Germany
Klinikum Region Hannover Klinikum Siloah
Hanover, Germany
Universitaetsklinikum Leipzig
Leipzig, 04103, Germany
Universitaetsklinikum Ulm
Ulm, 89075, Germany
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
HealthCare Global HCG Manavata Cancer Centre
Nashik, 422002, 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
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
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. 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
The Royal Marsden NHS Trust Sutton
Sutton, SM2 5PT, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 1, 2025
First Posted
December 11, 2025
Study Start
December 3, 2025
Primary Completion (Estimated)
June 18, 2029
Study Completion (Estimated)
June 18, 2029
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
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.