Clinical Research Directory
Browse clinical research sites, groups, and studies.
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
Sponsor: Janssen Research & Development, LLC
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.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
600
Start Date
2025-12-03
Completion Date
2029-07-18
Last Updated
2026-11-03
Healthy Volunteers
No
Conditions
Interventions
Amivantamab
Amivantamab will be administered.
Pembrolizumab
Pembrolizumab will be administered.
Carboplatin
Carboplatin will be administered.
5-Flurouracil
5-Flurouracil will be administered for over 4-day infusion period.
Cisplatin
Cisplatin will be administered.
Locations (205)
Ironwood Cancer and Research Center
Chandler, Arizona, United States
University of Arizona Cancer Center
Tucson, Arizona, United States
Providence St Jude Medical Center
Fullerton, California, United States
Scripps Health
La Jolla, California, United States
Valkyrie Clinical Trials
Los Angeles, California, United States
University of California, Los Angeles UCLA
Los Angeles, California, United States
Valkyrie Clinical Trials Murrieta
Murrieta, California, United States
University Of California - Davis
Sacramento, California, United States
UCSF Medical Center at Mission Bay
San Francisco, California, United States
Stanford University Medical Center
Stanford, California, United States
Hartford Hospital
Hartford, Connecticut, United States
Yale Cancer Center
New Haven, Connecticut, United States
Florida Cancer Specialists South
Fort Myers, Florida, United States
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States
AdventHealth Medical Group Oncology and Hematology at Orlando
Orlando, Florida, United States
Florida Cancer Specialists North Region
St. Petersburg, Florida, United States
Florida Cancer Specialists East
West Palm Beach, Florida, United States
Emory University
Atlanta, Georgia, United States
Central Georgia Cancer Care
Macon, Georgia, United States
Rush University Medical Center Rush University Cancer Center Chicago
Chicago, Illinois, United States
The University of Chicago Medical Center (UCMC)
Chicago, Illinois, United States
Cancer Care Specialists of Central Illinois
O'Fallon, Illinois, United States
University of Kentucky Medical Center
Lexington, Kentucky, United States
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Trinity Health St Joseph Mercy Ann Arbor
Ann Arbor, Michigan, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Washington University School Of Medicine
St Louis, Missouri, United States
NHO Revive Research Institute, LLC
Lincoln, Nebraska, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Laura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long Island
Mineola, New York, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Bronx Veterans Affairs Medical Center
The Bronx, New York, United States
Carolina Cancer Research Center
Wilson, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Oregon Health And Science University
Portland, Oregon, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
University of Pennsylvania Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Tennessee Cancer Specialists
Knoxville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Texas Oncology - San Antonio
Fredericksburg, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
UT Health East Texas HOPE Cancer Center
Tyler, Texas, United States
Texas Oncology-Central South
Waco, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
University of Virginia
Charlottesville, Virginia, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States
Monash Medical Centre
Clayton, Australia
Liverpool Hospital
Liverpool, Australia
Peter MacCallum Cancer Centre
Melbourne, Australia
St John of God Hospital Murdoch
Murdoch, Australia
GenesisCare
St Leonards, Australia
Tirol Kliniken MedUni Innsbruck
Innsbruck, Austria
Burgenlaendische Krankenanstalten Gesellschaft M B H Klinik Oberwart
Oberwart, Austria
Universitaetsklinikum Salzburg Landeskrankenhaus
Salzburg, Austria
University Hospital St. Poelten
Sankt Pölten, Austria
Medical University Vienna MUV
Vienna, Austria
UZ Antwerpen
Edegem, Belgium
Chu Helora Hospital La Louviere Site Jolimont
Haine-Saint-Paul, Belgium
Universitair Ziekenhuis Leuven
Leuven, Belgium
Vitaz
Sint-Niklaas, Belgium
Institut Roi Albert II
Woluwe-Saint-Lambert, Belgium
Fundacao Doutor Amaral Carvalho
Jaú, Brazil
Liga Norte Riograndense Contra O Cancer
Natal, Brazil
Irmandade Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Brazil
Funfarme Sjrp
São José do Rio Preto, Brazil
Hospital Alemao Oswaldo Cruz
São Paulo, Brazil
Associacao Feminina de Educacao e Combate ao Cancer Hospital Santa Rita de Cassia
Vitória, Brazil
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, China
Tongren Hospital Outpatient Bldg
Beijing, China
Beijing Cancer Hospital
Beijing, China
The Affiliated Hospital of Bengbu Medical College
Bengbu, China
The second Xiangya Hospital of Central South University
Changsha, China
Hunan Cancer hospital
Changsha, China
Sichuan Cancer Hospital
Chengdu, China
West China Hospital Sichuan University
Chengdu, China
Sichuan Provincial Peoples Hospital
Chengdu, China
Chongqing Cancer Hospital
Chongqing, China
Dongguan People s Hospital
Dongguan, China
Sun Yat-sen University Cancer Hospital
Guangzhou, China
Zhejiang Cancer Hospital
Hangzhou, China
The Affiliated Cancer Hospital of Shandong First Medical University
Jinan, China
Yunnan Cancer Hospital
Kunming, China
Linyi Cancer Hospital
Linyi, China
Nanjing Drum Tower Hospital
Nanjing, China
The Cancer Hospital Affiliated to Guangxi Medical University
Nanning, China
Fudan Cancer Hospital
Shanghai, China
Shanghai East Hospital
Shanghai, China
Tongji Hospital, Tongji Medical College of HUST
Wuhan, China
Union Hospital Tongji Medical College of Huazhong University of Science and Technology
Wuhan, China
Wuhan University - Zhongnan Hospital
Wuhan, China
The First Affiliated Hospital of Xian Jiaotong University
Xi'an, China
Yibin Second People's Hospital
Yibin, China
Fakultni nemocnice Hradec Kralove
Hradec Králové, Czechia
University Hospital Olomouc
Olomouc, Czechia
University Hospital Ostrava
Ostrava, Czechia