Clinical Trial

A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Head and Neck Cancer

Study acronym: OrigAMI-4
Recruiting Phase 1/2
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Summary
The purpose of this study is to determine safety and preliminary efficacy of amivantamab monotherapy, amivantamab in addition to pembrolizumab, amivantamab in addition to paclitaxel and amivantamab in addition to pembrolizumab and carboplatin in participants with recurrent/metastatic head and neck cancer. The study will also confirm the recommended Phase 2 combination dose (RP2CD) for amivantamab in addition to paclitaxel. The safety and preliminary efficacy of amivantamab in addition to pembrolizumab will also be determined in perioperative (before and after surgery) setting in participants with resectable locally advanced head and neck squamous cell carcinoma (HNSCC).
Protocol Amendment History 1 change
notable Primary completion pushed: 2027-12-27 -> 2032-12-27 2026-07-07
Trial Details
NCT Number NCT06385080
Lead Sponsor Janssen Research & Development, LLC
Conditions Squamous Cell Carcinoma of Head and Neck
Enrollment 287 participants
Start Date 2024-04-22
Primary Completion 2032-12-27 (estimated)
Study Completion 2032-12-27 (estimated)
Updated on ClinicalTrials.gov 2026-07-06