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Phase 3 study of amivantamab + carboplatin + pembrolizumab vs standard platinum + pembrolizumab + 5-FU in first-line recurrent/metastatic head and neck squamous cell carcinoma

2025-521917-24-00Phase 3Authorised

Sponsor
Janssen Pharmaceutical
Start
Jan 2026
Modality
Bispecific Antibodies → Multispecific Antibodies → Engineered Antibody Formats → Antibody-Based Therapeutics, Monoclonal Antibodies → Antibody-Based Therapeutics
Countries
22
01

Overview

Phase 3, randomised, open-label trial in head and neck squamous cell carcinoma (HNSCC) comparing Amivantamab + carboplatin + pembrolizumab with Standard-of-care platinum + pembrolizumab + 5-FU (2 arms). Primary endpoint: Overall Survival. Planned start Jan 2026; status: authorised.

02

Drugs

amivantamab
03

Conditions

head and neck squamous cell carcinoma (HNSCC)

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