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
Status: Recruiting
Location: See all (154) locations...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Arizona
Ironwood Cancer and Research Center
RECRUITING
Chandler
California
Providence St Jude Medical Center
RECRUITING
Fullerton
Valkyrie Clinical Trials
RECRUITING
Los Angeles
Valkyrie Clinical Trials Murrieta
RECRUITING
Murrieta
Stanford University Medical Center
RECRUITING
Stanford
Connecticut
Hartford Hospital
RECRUITING
Hartford
Yale Cancer Center
RECRUITING
New Haven
Florida
Florida Cancer Specialists South
RECRUITING
Fort Myers
Florida Cancer Specialists North Region
RECRUITING
St. Petersburg
Florida Cancer Specialists East
RECRUITING
West Palm Beach
Georgia
Emory University
RECRUITING
Atlanta
Central Georgia Cancer Care
RECRUITING
Macon
Illinois
Rush University Medical Center Rush University Cancer Center Chicago
RECRUITING
Chicago
The University of Chicago Medical Center (UCMC)
RECRUITING
Chicago
Cancer Care Specialists of Central Illinois
RECRUITING
O'fallon
Kentucky
University of Kentucky Medical Center
RECRUITING
Lexington
Michigan
Karmanos Cancer Institute
RECRUITING
Detroit
Missouri
Washington University School Of Medicine
RECRUITING
St Louis
North Carolina
Carolina Cancer Research Center
RECRUITING
Wilson
Nebraska
NHO Revive Research Institute, LLC
RECRUITING
Lincoln
New York
Laura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long Island
RECRUITING
Mineola
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health
RECRUITING
New York
Bronx Veterans Affairs Medical Center
RECRUITING
The Bronx
Montefiore Medical Center
RECRUITING
The Bronx
Ohio
Ohio State University
RECRUITING
Columbus
Oregon
Oregon Health And Science University
RECRUITING
Portland
Tennessee
Tennessee Cancer Specialists
RECRUITING
Knoxville
Texas
Texas Oncology - San Antonio
RECRUITING
Fredericksburg
Texas Oncology-Central South
RECRUITING
Waco
Utah
Huntsman Cancer Institute
RECRUITING
Salt Lake City
Virginia
Virginia Cancer Specialists
RECRUITING
Arlington
Other Locations
Australia
Monash Medical Centre
RECRUITING
Clayton
Peter MacCallum Cancer Centre
RECRUITING
Melbourne
St John of God Hospital Murdoch
RECRUITING
Murdoch
GenesisCare
RECRUITING
St Leonards
Austria
Universitaetsklinikum Salzburg Landeskrankenhaus
RECRUITING
Salzburg
University Hospital St. Poelten
RECRUITING
Sankt Pölten
Belgium
UZ Antwerpen
RECRUITING
Edegem
Chu Helora Hospital La Louviere Site Jolimont
RECRUITING
Haine-saint-paul
Universitair Ziekenhuis Leuven
RECRUITING
Leuven
Vitaz
RECRUITING
Sint-niklaas
Brazil
Fundacao Doutor Amaral Carvalho
RECRUITING
Jaú
Liga Norte Riograndense Contra O Cancer
RECRUITING
Natal
Irmandade da Santa Casa de Misericordia de Porto Alegre
RECRUITING
Porto Alegre
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto - Centro Integrado de Pesquisa
RECRUITING
São José Do Rio Preto
Hospital Alemao Oswaldo Cruz
RECRUITING
São Paulo
Associacao Feminina de Educacao e Combate ao Cancer Hospital Santa Rita de Cassia
RECRUITING
Vitória
China
Beijing Cancer Hospital
RECRUITING
Beijing
Tongren Hospital Outpatient Bldg
RECRUITING
Beijing
The Affiliated Hospital of Bengbu Medical College
RECRUITING
Bengbu
Hunan Cancer hospital
RECRUITING
Changsha
The second Xiangya Hospital of Central South University
RECRUITING
Changsha
Sichuan Cancer Hospital
RECRUITING
Chengdu
Sichuan Provincial Peoples Hospital
RECRUITING
Chengdu
West China Hospital Sichuan University
RECRUITING
Chengdu
Chongqing Cancer Hospital
RECRUITING
Chongqing
Dongguan People s Hospital
RECRUITING
Dongguan
Sun Yat-sen University Cancer Hospital
RECRUITING
Guangzhou
The Affiliated Cancer Hospital of Shandong First Medical University
RECRUITING
Jinan
Yunnan Cancer Hospital
RECRUITING
Kunming
Linyi Cancer Hospital
RECRUITING
Linyi
Nanjing Drum Tower Hospital
RECRUITING
Nanjing
The Cancer Hospital Affiliated to Guangxi Medical University
RECRUITING
Nanning
Fudan Cancer Hospital
RECRUITING
Shanghai
Shanghai East Hospital
RECRUITING
Shanghai
Tongji Hospital, Tongji Medical College of HUST
RECRUITING
Wuhan
Union Hospital Tongji Medical College of Huazhong University of Science and Technology
RECRUITING
Wuhan
Wuhan University - Zhongnan Hospital
RECRUITING
Wuhan
Yibin Second People's Hospital
RECRUITING
Yibin
France
Institut Sainte Catherine
RECRUITING
Avignon
Clinique Victor Hugo
RECRUITING
Le Mans
Centre Oscar Lambret
RECRUITING
Lille
Assistance Publique Hopitaux de Marseille (AP-HM) - Hopital
RECRUITING
Marseille
Assistance Publique - Hopitaux de Paris
RECRUITING
Paris
Institut Curie
RECRUITING
Paris
Centre Henri Becquerel
RECRUITING
Rouen
Institut Gustave Roussy
RECRUITING
Villejuif
Germany
Universitaetsklinikum Giessen und Marburg GmbH
RECRUITING
Giessen
Klinikum Region Hannover Klinikum Siloah
RECRUITING
Hanover
Universitaetsklinikum Leipzig
RECRUITING
Leipzig
Universitaetsklinikum Ulm
RECRUITING
Ulm
Hungary
Debreceni Egyetem Klinikai Kozpont
RECRUITING
Debrecen
Gyor Moson Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
RECRUITING
Győr
Pecsi Tudomanyegyetem Klinikai Kozpont
RECRUITING
Pécs
Nograd Varmegyei Szent Lazar Korhaz
RECRUITING
Salgótarján
India
Apollo Speciality Hospital, Chennai
RECRUITING
Chennai
Bhagwan Mahaveer Cancer Hospital & Research Centre
RECRUITING
Jaipur
HealthCare Global HCG Manavata Cancer Centre
RECRUITING
Nashik
Kailash Cancer Hospital and Research Centre
RECRUITING
Vadodara
Italy
European Institute of Oncology
RECRUITING
Milan
Fondazione IRCCS Istituto Nazionale dei Tumori
RECRUITING
Milan
Fondazione G Pascale Istituto Nazionale Tumori IRCCS
RECRUITING
Naples
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
RECRUITING
Palermo
IRCCS Policlinico San Matteo, Università degli studi di Pavi
RECRUITING
Pavia
AOU Policlinico Umberto I
RECRUITING
Roma
Istituto Clinico Humanitas
RECRUITING
Rozzano
Japan
Kansai Medical University Hospital
RECRUITING
Hirakata
National Cancer Center Hospital East
RECRUITING
Kashiwa
Hokkaido University Hospital
RECRUITING
Sapporo
Tokyo Medical University Hospital
RECRUITING
Shinjuku
Shizuoka Cancer Center
RECRUITING
Sunto Gun
National Cancer Center Hospital
RECRUITING
Tokyo
The Cancer Institute Hospital of JFCR
RECRUITING
Tokyo
Mexico
CO de Chihuahua
RECRUITING
Chihuahua City
Act. Basada en la Inv. Del Ca
RECRUITING
Guadalajara
Gefarma Atrys
RECRUITING
Mexico City
P. y S. Oncologicos Acacias
RECRUITING
Mexico City
Cuidados Oncologicos
RECRUITING
Querétaro
Find My Cancer Cen de Inv Clin
RECRUITING
Tijuana
Poland
Uniwersyteckie Centrum Kliniczne
RECRUITING
Gdansk
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz w Gliwicach
RECRUITING
Gliwice
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi
RECRUITING
Lodz
Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli
RECRUITING
Lublin
Wielkopolskie Centrum Onkologii im. Marii Sklodowskiej-Curie
RECRUITING
Poznan
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
RECRUITING
Warsaw
Portugal
Hosp. Cuf Descobertas
RECRUITING
Lisbon
Uls Santa Maria - Hosp. Santa Maria
RECRUITING
Lisbon
Hospital de Portimao-Centro Hospitalar do Barlavento Algarvio
RECRUITING
Portimão
Instituto Portugues de Oncologia
RECRUITING
Porto
Uls Gaia Espinho
RECRUITING
Vila Nova De Gaia
Republic of Korea
Asan Medical Center
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Severance Hospital Yonsei University Health System
RECRUITING
Seoul
Romania
Spitalul Clinic Coltea
RECRUITING
Bucharest
Cardiomed
RECRUITING
Cluj-napoca
Institutul Oncologic 'Prof Dr. Ion Chiricuta' Cluj-Napoca
RECRUITING
Cluj-napoca
Clinica de Oncologie Sf Nectarie
RECRUITING
Craiova
Institutul Regional de Oncologie Iasi
RECRUITING
Iași
Oncocenter Oncologie Clinica SRL
RECRUITING
Timișoara
Spain
Hosp Univ Vall D Hebron
RECRUITING
Barcelona
Hosp. Gral. Univ. Gregorio Maranon
RECRUITING
Madrid
Hosp. Univ. 12 de Octubre
RECRUITING
Madrid
Hospital Clinico San Carlos
RECRUITING
Madrid
Complejo Hosp de Navarra - Hosp de Navarra
RECRUITING
Pamplona
Hosp. Clinico Univ. de Santiago
RECRUITING
Santiago De Compostela
Hosp. Univ. Miguel Servet
RECRUITING
Zaragoza
Taiwan
Changhua Christian Hospital
RECRUITING
Changhua
Kaohsiung Chang Gung Memorial Hospital
RECRUITING
Kaohsiung City
Kaohsiung Medical University Chung Ho Memorial Hospital
RECRUITING
Kaohsiung City
China Medical University Hospital
RECRUITING
Taichung
National Cheng Kung University Hospital
RECRUITING
Tainan
National Taiwan University Hospital
RECRUITING
Taipei
Taipei Veterans General Hospital
RECRUITING
Taipei
United Kingdom
Addenbrooke's Hospital
RECRUITING
Cambridge
Castle Hill Hospital
RECRUITING
Cottingham
Western General Hospital
RECRUITING
Edinburgh
Guy's and St Thomas' NHS Foundation Trust
RECRUITING
Greater London
Royal Surrey County Hospital NHS Trust
RECRUITING
Guildford
Royal Marsden Hospital Chelsea
RECRUITING
London
St Bartholomew's Hospital
RECRUITING
London
The Clatterbridge Cancer Centre
RECRUITING
Metropolitan Borough Of Wirral
Mount Vernon Cancer Centre
RECRUITING
Northwood
The Royal Marsden NHS Trust Sutton
RECRUITING
Sutton
Contact Information
Primary
Study Contact
Participate-In-This-Study1@its.jnj.com
844-434-4210
Time Frame
Start Date: 2025-12-03
Estimated Completion Date: 2029-06-18
Participants
Target number of participants: 500
Treatments
Experimental: Arm A: Pembrolizumab, Amivantamab, Carboplatin
Participants will receive pembrolizumab, amivantamab and carboplatin.
Active_comparator: Arm B: Pembrolizumab, 5-Flurouracil (5-FU), Carboplatin or Cisplatin
Participants will receive pembrolizumab, 5-FU and carboplatin or cisplatin (platinum therapy).
Related Therapeutic Areas
Sponsors
Leads: Janssen Research & Development, LLC