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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
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
Who can join
Ages 18 and older · All sexes
Full eligibility 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
About the study
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.
What is being tested
- Amivantamab (biological)
- Pembrolizumab (biological)
- Carboplatin (drug)
- 5-Flurouracil (drug)
- Cisplatin (drug)
Sponsor: Janssen Research & Development, LLC · Participants: 500 · Started: Dec 3, 2025
Contact the study team
- Study Contact · Phone: 844-434-4210
Official record on ClinicalTrials.gov — NCT07276399
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.