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OrigAMI-5: Amivantamab SC + pembrolizumab + platinum + 5-FU vs standard of care in recurrent/metastatic head and neck squamous cell carcinoma
CTR20254647Phase 3Active
- Sponsor
- Janssen Pharmaceutical
- Start
- Feb 2026
- Modality
- Bispecific Antibodies → Multispecific Antibodies → Engineered Antibody Formats → Antibody-Based Therapeutics, Monoclonal Antibodies → Antibody-Based Therapeutics
- Countries
- 1
01
Overview
Phase 3, randomised, open-label trial in head and neck squamous cell carcinoma (HNSCC) comparing Amivantamab SC + pembrolizumab + platinum + 5-FU with Pembrolizumab + platinum + 5-FU (standard of care) (2 arms). Primary endpoints: Overall survival (OS) and Objective response rate (ORR) by BICR per RECIST 1.1. Started Feb 2026; status: active.
02
Drugs
amivantamab
03
Conditions
head and neck squamous cell carcinoma (HNSCC)
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