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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Ironwood Cancer and Research Center
  Chandler, Arizona, United States Recruiting
• University of Arizona Cancer Center
  Tucson, Arizona, United States Recruiting
• Providence St Jude Medical Center
  Fullerton, California, United States Recruiting
• Scripps Health
  La Jolla, California, United States Recruiting
• Valkyrie Clinical Trials
  Los Angeles, California, United States Recruiting
• University of California, Los Angeles UCLA
  Los Angeles, California, United States Recruiting

+155 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Study Contact
• Email: Participate-In-This-Study1@its.jnj.com
• Phone: 844-434-4210

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.