OrigAMI-5
Research type
Research Study
Full title
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
IRAS ID
1012977
Contact name
Joe Taylor
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2025-521917-24
ISRCTN Number
ISRCTN13351736
Research summary
Head and neck squamous cell carcinoma (HNSCC), is a type of solid tumour that begins in the mouth and throat. Available treatments may not work well for all participants. Thus, better therapies are required for the treatment of HNSCC in order to improve outcomes and the quality of life.
Amivantamab (JNJ-61186372) is a human immunoglobulin G1 (IgG1)-based bispecific antibody* that simultaneously inhibits the activity of two proteins, epidermal growth factor receptor (EGFR) and mesenchymal-epithelial transition (MET). Binding to EGFR and MET, turns them off, which may slow down the growth of cancer cells or kill them.
*Protein that helps protect the body against foreign matter.
In this study, researchers want to compare the ability of amivantamab to slow down or stop the growth of tumours and overall survival when given along with pembrolizumab and carboplatin versus pembrolizumab with 5-fluorouracil (5-FU) and carboplatin or cisplatin treatment. Study will focus on participants who have treatment-naïve HNSCC (that is, have not received prior treatment).
REC name
London - Dulwich Research Ethics Committee
REC reference
25/LO/0744
Date of REC Opinion
7 Nov 2025
REC opinion
Further Information Favourable Opinion