Recruiting

Phase 3

Amivantamab & PembrolizumabA 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

Code:

NCT07276399

Conditions

Squamous Cell Carcinoma of Head and Neck

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Amivantamab

Pembrolizumab

Carboplatin

5-Flurouracil

Cisplatin

Study Details

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.

Conditions

Squamous Cell Carcinoma of Head and Neck

Study ID

NCT07276399

Start date

Dec 3, 2025

Status verified date

Aug, 2026

Completion date

Jun 18, 2029

Anticipated

Primary completion date

Jun 18, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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).

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.

Primary outcome measure

Overall Survival (OS) [ Time Frame: 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) [ Time Frame: Up to approximately 3 years 7 months ]

Central Contacts and Locations

Central contacts

Study Contact

844-434-4210 Participate-In-This-Study1@its.jnj.com

Locations

Ironwood Cancer and Research Center

Recruiting

Chandler, Arizona, United States, 85224

University of Arizona Cancer Center

Recruiting

Tucson, Arizona, United States, 85719

Providence St Jude Medical Center

Recruiting

Fullerton, California, United States, 92835

Scripps Health

Recruiting

La Jolla, California, United States, 92037

Valkyrie Clinical Trials

Recruiting

Los Angeles, California, United States, 90067

University of California, Los Angeles UCLA

Recruiting

Los Angeles, California, United States, 90095

Valkyrie Clinical Trials Murrieta

Recruiting

Murrieta, California, United States, 92562

University Of California - Davis

Recruiting

Sacramento, California, United States, 95817

Stanford University Medical Center

Recruiting

Stanford, California, United States, 94304

Hartford Hospital

Recruiting

Hartford, Connecticut, United States, 06102

Yale Cancer Center

Recruiting

New Haven, Connecticut, United States, 06510

Florida Cancer Specialists South

Recruiting

Fort Myers, Florida, United States, 33901

University of Miami Sylvester Comprehensive Cancer Center

Recruiting

Miami, Florida, United States, 33136

AdventHealth Medical Group Oncology and Hematology at Orlando

Recruiting

Orlando, Florida, United States, 32804

Florida Cancer Specialists North Region

Recruiting

St. Petersburg, Florida, United States, 33701-4553

Florida Cancer Specialists East

Recruiting

West Palm Beach, Florida, United States, 33401-3406

Emory University

Recruiting

Atlanta, Georgia, United States, 30308

Central Georgia Cancer Care

Recruiting

Macon, Georgia, United States, 31210

Rush University Medical Center Rush University Cancer Center Chicago

Recruiting

Chicago, Illinois, United States, 60607

The University of Chicago Medical Center (UCMC)

Recruiting

Chicago, Illinois, United States, 60637

Cancer Care Specialists of Central Illinois

Recruiting

O'Fallon, Illinois, United States, 62269

University of Kentucky Medical Center

Recruiting

Lexington, Kentucky, United States, 40536

University of Maryland Greenebaum Cancer Center

Recruiting

Baltimore, Maryland, United States, 21201

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02115

Trinity Health St Joseph Mercy Ann Arbor

Recruiting

Ann Arbor, Michigan, United States, 48197

Karmanos Cancer Institute

Recruiting

Detroit, Michigan, United States, 48201 2013

Washington University School Of Medicine

Recruiting

St Louis, Missouri, United States, 63108

NHO Revive Research Institute, LLC

Recruiting

Lincoln, Nebraska, United States, 68506

Rutgers Cancer Institute of New Jersey

Recruiting

New Brunswick, New Jersey, United States, 08903

Laura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long Island

Recruiting

Mineola, New York, United States, 11501

Laura and Isaac Perlmutter Cancer Center at NYU Langone Health

Recruiting

New York, New York, United States, 10016

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10461

Bronx Veterans Affairs Medical Center

Recruiting

The Bronx, New York, United States, 10468

Carolina Cancer Research Center

Recruiting

Wilson, North Carolina, United States, 27893

University of Cincinnati

Recruiting

Cincinnati, Ohio, United States, 45219

Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Oregon Health And Science University

Recruiting

Portland, Oregon, United States, 97239

Penn State Milton S. Hershey Medical Center

Recruiting

Hershey, Pennsylvania, United States, 17033

Tennessee Cancer Specialists

Recruiting

Knoxville, Tennessee, United States, 37909

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Texas Oncology - San Antonio

Recruiting

Fredericksburg, Texas, United States, 78624

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Texas Oncology-Central South

Recruiting

Waco, Texas, United States, 76712

Huntsman Cancer Institute

Recruiting

Salt Lake City, Utah, United States, 84112

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22908

Virginia Cancer Specialists

Recruiting

Fairfax, Virginia, United States, 22031

More Information

Sponsor

Janssen Research & Development, LLC

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Janssen Research & Development, LLC on 2026-08-28.