A Phase 3, Randomized, Open-Label, Multicenter Study of Amivantamab in Addition to Carboplatin and Pembrolizumab Compared to Standard Platinum, Pembrolizumab, and 5-FU in Treatment-Naive RecurrentMetastatic Head and Neck Squamous Cell Carcinoma

What this Trial Is About

Researchers are evaluating the anti-tumor activity of adding amivantamab to pembrolizumab and carboplatin compared to pembrolizumab combined with 5-fluorouracil and platinum therapy carboplatin or cisplatin in participants with recurrent or metastatic head and neck squamous cell carcinoma HNSCC who have not received prior systemic treatment in this setting. HNSCC is a cancer affecting areas such as the mouth and throat. This phase 3, randomized, open-label study aims to better understand treatment options for this condition. Participants are assigned randomly to one of two treatment groups. One group receives pembrolizumab, amivantamab, and carboplatin, while the other group receives pembrolizumab, 5-fluorouracil administered via a 4-day infusion, and either carboplatin or cisplatin. The treatments are given as part of standard care agents, and the study compares these combinations to assess their effects and safety over time. Throughout the study, participants will be monitored for overall survival and tumor response using established criteria over approximately three years and seven months. Additional assessments include progression-free survival, duration of response, quality of life questionnaires focusing on symptoms and functioning, and safety evaluations such as adverse event tracking and laboratory testing. Blood samples will also be collected to measure amivantamab concentration and antibodies. The study involves multiple visits and evaluations to thoroughly assess the treatments impact and participant well-being.

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