Phase 1b2 Study of Amivantamab Alone or Combined With Other Drugs to Treat Head and Neck Squamous Cell Carcinoma

What this Trial Is About

This research aims to evaluate the safety and preliminary effectiveness of amivantamab alone and combined with other treatments in participants with recurrent or metastatic head and neck squamous cell carcinoma HNSCC and in those with locally advanced HNSCC who can undergo surgery. The study also seeks to establish the recommended Phase 2 combination dose of amivantamab when given with paclitaxel. Additionally, the safety and effectiveness of amivantamab combined with pembrolizumab will be assessed before and after surgery in participants with resectable locally advanced HNSCC. Participants will receive subcutaneous injections of amivantamab at doses adjusted by body weight on specific schedules, either alone or combined with intravenous pembrolizumab, paclitaxel, or carboplatin, depending on their assigned cohort. Dose confirmation and expansion cohorts will help determine the appropriate dosing. For those in the perioperative setting, amivantamab and pembrolizumab will be given in both neoadjuvant before surgery and adjuvant after surgery phases with specific dosing schedules extending up to 15 cycles. Participants will be assessed for tumor response, treatment-related toxicities, and survival outcomes over a period extending up to about two years. Researchers will monitor treatment-emergent adverse events, dosing tolerability, and measure outcomes such as objective response rate, duration of response, progression-free survival, overall survival, and major pathologic response. Laboratory tests, imaging, and clinical evaluations will be performed to evaluate safety and efficacy throughout the study duration.

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