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

NCT07276399 · tracked via the Priya Life Science USA tracker

Sponsor

Janssen Research & Development, LLC

Phase

Phase 3

Started

2025-12-03

Last updated

2026-08-28

Condition(s) studied

Squamous Cell Carcinoma of Head and Neck

Investigational drug(s) / intervention(s)

AmivantamabPembrolizumabCarboplatin5-FlurouracilCisplatin

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.

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Overall Survival (OS) — 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.
Objective Response Rate (ORR) Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Blinded Independent Central Review (BICR) — 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 .

Trial sites (201)

Facility	City	Region	Status
Ironwood Cancer and Research Center	Chandler	Arizona	Recruiting
University of Arizona Cancer Center	Tucson	Arizona	Recruiting
Providence St Jude Medical Center	Fullerton	California	Recruiting
Scripps Health	La Jolla	California	Recruiting
Valkyrie Clinical Trials	Los Angeles	California	Recruiting
University of California, Los Angeles UCLA	Los Angeles	California	Recruiting
Valkyrie Clinical Trials Murrieta	Murrieta	California	Recruiting
University Of California - Davis	Sacramento	California	Recruiting
Stanford University Medical Center	Stanford	California	Recruiting
Hartford Hospital	Hartford	Connecticut	Recruiting
Yale Cancer Center	New Haven	Connecticut	Recruiting
Florida Cancer Specialists South	Fort Myers	Florida	Recruiting
University of Miami Sylvester Comprehensive Cancer Center	Miami	Florida	Recruiting
AdventHealth Medical Group Oncology and Hematology at Orlando	Orlando	Florida	Recruiting
Florida Cancer Specialists North Region	St. Petersburg	Florida	Recruiting
Florida Cancer Specialists East	West Palm Beach	Florida	Recruiting
Emory University	Atlanta	Georgia	Recruiting
Central Georgia Cancer Care	Macon	Georgia	Recruiting
Rush University Medical Center Rush University Cancer Center Chicago	Chicago	Illinois	Recruiting
The University of Chicago Medical Center (UCMC)	Chicago	Illinois	Recruiting
Cancer Care Specialists of Central Illinois	O'Fallon	Illinois	Recruiting
University of Kentucky Medical Center	Lexington	Kentucky	Recruiting
University of Maryland Greenebaum Cancer Center	Baltimore	Maryland	Recruiting
Dana Farber Cancer Institute	Boston	Massachusetts	Recruiting
Trinity Health St Joseph Mercy Ann Arbor	Ann Arbor	Michigan	Recruiting
Karmanos Cancer Institute	Detroit	Michigan	Recruiting
Washington University School Of Medicine	St Louis	Missouri	Recruiting
NHO Revive Research Institute, LLC	Lincoln	Nebraska	Recruiting
Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey	Recruiting
Laura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long Island	Mineola	New York	Recruiting
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health	New York	New York	Recruiting
Montefiore Medical Center	The Bronx	New York	Recruiting
Bronx Veterans Affairs Medical Center	The Bronx	New York	Recruiting
Carolina Cancer Research Center	Wilson	North Carolina	Recruiting
University of Cincinnati	Cincinnati	Ohio	Recruiting
Ohio State University	Columbus	Ohio	Recruiting
Oregon Health And Science University	Portland	Oregon	Recruiting
Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania	Recruiting
Tennessee Cancer Specialists	Knoxville	Tennessee	Recruiting
Vanderbilt University Medical Center	Nashville	Tennessee	Recruiting

+ 161 more sites — see the full list on the official registry below.

On this site

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Other trials for the same condition

A Study of DM005 in Patients With Advanced Solid Tumors Recruiting

A Clinical Trial Evaluating TG4050 in Head and Neck Cancer Active, not recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07276399 on ClinicalTrials.gov ↗ ← All trials in the USA