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

Recruiting now · Phase 3

Conditions studied: Squamous Cell Carcinoma of Head and Neck

In brief

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.

Key facts

Study ID

NCT07276399

Run by

Janssen Research & Development, LLC

People needed

500

Starts

2025-12-03

Expected to finish

2029-06-18

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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