Clinical Trial

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

Study acronym: OrigAMI-5
Recruiting Phase 3
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Summary
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.
Protocol Amendment History 4 changes
notable Trial sites expanded: 186 -> 196 locations 2026-07-07
notable Trial sites expanded: 177 -> 186 locations 2026-06-06
notable Trial sites expanded: 160 -> 177 locations 2026-05-09
notable Trial sites expanded: 137 -> 160 locations 2026-04-14
Trial Details
NCT Number NCT07276399
Lead Sponsor Janssen Research & Development, LLC
Conditions Squamous Cell Carcinoma of Head and Neck
Enrollment 500 participants
Start Date 2025-12-03
Primary Completion 2029-06-18 (estimated)
Study Completion 2029-06-18 (estimated)
Updated on ClinicalTrials.gov 2026-07-31