πŸ›οΈ Verified NIH Record β€’ Updated 2026-08-27

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)

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-NaΓ―ve Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

🟒 Recruiting Phase3 πŸ’Š Investigational Drug / Biologic Sponsor: Janssen Research & Development, LLC

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Ironwood Cancer and Research Center β€” Chandler, Arizona

Age range: 18 Years

πŸ“‹ "Do I Qualify?" β€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria β†—

πŸ“ All Participating Trial Locations (201 Sites)

Showing the first 25 of 201 sites.

  • Ironwood Cancer and Research Center β€” Chandler, Arizona
  • University of Arizona Cancer Center β€” Tucson, Arizona
  • Providence St Jude Medical Center β€” Fullerton, California
  • Scripps Health β€” La Jolla, California
  • Valkyrie Clinical Trials β€” Los Angeles, California
  • University of California, Los Angeles UCLA β€” Los Angeles, California
  • Valkyrie Clinical Trials Murrieta β€” Murrieta, California
  • University Of California - Davis β€” Sacramento, California
  • Stanford University Medical Center β€” Stanford, California
  • Hartford Hospital β€” Hartford, Connecticut
  • Yale Cancer Center β€” New Haven, Connecticut
  • Florida Cancer Specialists South β€” Fort Myers, Florida
  • University of Miami Sylvester Comprehensive Cancer Center β€” Miami, Florida
  • AdventHealth Medical Group Oncology and Hematology at Orlando β€” Orlando, Florida
  • Florida Cancer Specialists North Region β€” St. Petersburg, Florida
  • Florida Cancer Specialists East β€” West Palm Beach, Florida
  • Emory University β€” Atlanta, Georgia
  • Central Georgia Cancer Care β€” Macon, Georgia
  • Rush University Medical Center Rush University Cancer Center Chicago β€” Chicago, Illinois
  • The University of Chicago Medical Center (UCMC) β€” Chicago, Illinois
  • Cancer Care Specialists of Central Illinois β€” O'Fallon, Illinois
  • University of Kentucky Medical Center β€” Lexington, Kentucky
  • University of Maryland Greenebaum Cancer Center β€” Baltimore, Maryland
  • Dana Farber Cancer Institute β€” Boston, Massachusetts
  • Trinity Health St Joseph Mercy Ann Arbor β€” Ann Arbor, Michigan

πŸ“ž Contact the Study Coordinator

Phone: (844) 434-4210

Email: Participate-In-This-Study1@its.jnj.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

πŸ’° Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA Β§ 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

πŸ’‘ How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
πŸ›οΈ View Official NIH Record β†—