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Amivantamab added to pembrolizumab and platinum chemotherapy versus pembrolizumab with platinum/5‑FU for recurrent/metastatic head and neck squamous cell carcinoma

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

Phase 3 Interventional Janssen Research & Development, LLC · NCT07276399

This trial will see if adding amivantamab to pembrolizumab and platinum‑based chemotherapy helps adults with recurrent or metastatic head and neck squamous cell carcinoma who have not yet had systemic treatment in the metastatic setting.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment500 (estimated)
Ages18 Years and up
SexAll
SponsorJanssen Research & Development, LLC Industry-sponsored
Drugs / interventionsAmivantamab, Pembrolizumab
Locations177 sites (Chandler, Arizona and 176 other locations)
Trial IDNCT07276399 on ClinicalTrials.gov

What this trial studies

This is a randomized Phase 3 trial comparing the anti‑tumor activity of amivantamab plus pembrolizumab and carboplatin against the current pembrolizumab with platinum (carboplatin or cisplatin) and 5‑fluorouracil regimen in participants with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). Eligible participants are treatment‑naive in the recurrent/metastatic setting, have measurable disease and an ECOG performance status of 0–1, and tumors from specified primary sites excluding nasopharynx and HPV‑positive oropharyngeal cancers. The trial will measure tumor response and disease control outcomes to compare the two regimens. Enrollment is being conducted at selected U.S. cancer centers.

Who should consider this trial

Good fit: Adults (≥18) with histologically confirmed recurrent or metastatic squamous cell carcinoma of the oral cavity, oropharynx (HPV‑negative), hypopharynx, or larynx who are treatment‑naive in the R/M setting, have measurable disease, and an ECOG performance status of 0–1.

Not a fit: Patients with primary nasopharyngeal tumors or HPV‑positive oropharyngeal cancers, those who have already received systemic therapy for recurrent/metastatic disease, or those with ECOG >1 are unlikely to be eligible or to benefit from this protocol.

Why it matters

Potential benefit: If successful, adding amivantamab could increase tumor response rates and delay progression compared with current pembrolizumab‑based chemotherapy.

How similar studies have performed: Pembrolizumab combined with platinum and 5‑FU is an established standard of care, while the use of amivantamab in head and neck cancer is an investigational approach with limited prior clinical data.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Chandler, Arizona and 176 other locations

+127 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Squamous Cell Carcinoma of Head and Neck
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.