NCT07276399From ClinicalTrials.govRecruiting

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, 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

Squamous Cell Carcinoma of Head and Neck

At a glance

Phase: Phase 3
Study type: Interventional
Sponsor: Janssen Research & Development, LLC
Enrolment target: 500
Started: 3 December 2025
Main results due: 18 June 2029
Study sites: 203
Registry updated: 25 September 2026

Can you take part?

Aged 18 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

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

What this study is about

In the sponsor’s own words, from the registry.

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 sites(203)

Ironwood Cancer and Research Center
Chandler, Arizona, United States
Recruiting
University of Arizona Cancer Center
Tucson, Arizona, United States
Recruiting
Providence St Jude Medical Center
Fullerton, California, United States
Recruiting
Scripps Health
La Jolla, California, United States
Recruiting
Valkyrie Clinical Trials
Los Angeles, California, United States
Recruiting
University of California, Los Angeles UCLA
Los Angeles, California, United States
Recruiting
Valkyrie Clinical Trials Murrieta
Murrieta, California, United States
Recruiting
University Of California - Davis
Sacramento, California, United States
Recruiting
Stanford University Medical Center
Stanford, California, United States
Recruiting
Hartford Hospital
Hartford, Connecticut, United States
Recruiting
Yale Cancer Center
New Haven, Connecticut, United States
Recruiting
Florida Cancer Specialists South
Fort Myers, Florida, United States
Recruiting
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Recruiting
AdventHealth Medical Group Oncology and Hematology at Orlando
Orlando, Florida, United States
Recruiting
Florida Cancer Specialists North Region
St. Petersburg, Florida, United States
Recruiting
Florida Cancer Specialists East
West Palm Beach, Florida, United States
Recruiting
Emory University
Atlanta, Georgia, United States
Recruiting
Central Georgia Cancer Care
Macon, Georgia, United States
Recruiting
Rush University Medical Center Rush University Cancer Center Chicago
Chicago, Illinois, United States
Recruiting
The University of Chicago Medical Center (UCMC)
Chicago, Illinois, United States
Recruiting
Cancer Care Specialists of Central Illinois
O'Fallon, Illinois, United States
Recruiting
University of Kentucky Medical Center
Lexington, Kentucky, United States
Recruiting
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, United States
Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Recruiting
Trinity Health St Joseph Mercy Ann Arbor
Ann Arbor, Michigan, United States
Recruiting
Karmanos Cancer Institute
Detroit, Michigan, United States
Recruiting
Washington University School Of Medicine
St Louis, Missouri, United States
Recruiting
NHO Revive Research Institute, LLC
Lincoln, Nebraska, United States
Recruiting
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Recruiting
Laura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long Island
Mineola, New York, United States
Recruiting
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, United States
Recruiting
Montefiore Medical Center
The Bronx, New York, United States
Recruiting
Bronx Veterans Affairs Medical Center
The Bronx, New York, United States
Recruiting
Carolina Cancer Research Center
Wilson, North Carolina, United States
Recruiting
University of Cincinnati
Cincinnati, Ohio, United States
Recruiting
Ohio State University
Columbus, Ohio, United States
Recruiting
Oregon Health And Science University
Portland, Oregon, United States
Recruiting
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Recruiting
University of Pennsylvania Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States
Recruiting
Tennessee Cancer Specialists
Knoxville, Tennessee, United States
Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Recruiting
UT Southwestern Medical Center
Dallas, Texas, United States
Recruiting
Texas Oncology - San Antonio
Fredericksburg, Texas, United States
Recruiting
MD Anderson Cancer Center
Houston, Texas, United States
Recruiting
UT Health East Texas HOPE Cancer Center
Tyler, Texas, United States
Recruiting
Texas Oncology-Central South
Waco, Texas, United States
Recruiting
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Recruiting
University of Virginia
Charlottesville, Virginia, United States
Recruiting
Virginia Cancer Specialists
Fairfax, Virginia, United States
Recruiting
Monash Medical Centre
Clayton, Australia
Recruiting
Liverpool Hospital
Liverpool, Australia
Recruiting
Peter MacCallum Cancer Centre
Melbourne, Australia
Recruiting
St John of God Hospital Murdoch
Murdoch, Australia
Recruiting
GenesisCare
St Leonards, Australia
Recruiting
Tirol Kliniken MedUni Innsbruck
Innsbruck, Austria
Recruiting
Burgenlaendische Krankenanstalten Gesellschaft M B H Klinik Oberwart
Oberwart, Austria
Recruiting
Universitaetsklinikum Salzburg Landeskrankenhaus
Salzburg, Austria
Recruiting
University Hospital St. Poelten
Sankt Pölten, Austria
Recruiting
Medical University Vienna MUV
Vienna, Austria
Recruiting
UZ Antwerpen
Edegem, Belgium
Recruiting

Showing 60 of 203 sites — filter to narrow it down. 203 of the 203 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07276399. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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