Phase 2 Study Evaluating VS-101 with Chemoradiotherapy for Adults with Head and Neck Squamous Cell Carcinoma

What this Trial Is About

This trial is a multi-center, randomized, open-label study designed to evaluate the efficacy and safety of VS-101 combined with chemoradiotherapy CRT in adults diagnosed with head and neck squamous cell carcinoma. It focuses on patients with cancers of the oral cavity, oropharynx, hypopharynx, or larynx, specifically those at stage III, IVa, or IVb as defined by AJCC guidelines. The study aims to assess treatment outcomes such as tumor response and disease control in this population. Participants are assigned to one of three groups receiving 2 mg of VS-101 plus CRT, 5 mg of VS-101 plus CRT, or CRT alone. The CRT includes standard intensity-modulated radiation therapy with a planned cumulative dose of approximately 70 Gy. This phase 2 study compares these treatment regimens to evaluate safety and effectiveness over a period extending to 12 months. Throughout the study, participants will be closely monitored with evaluations including tumor size measurement, disease progression, survival, and quality of life assessments at various time points up to one year. Safety is tracked by recording adverse events throughout the study. Participants are expected to comply with all protocol requirements and will undergo multiple assessments to measure the primary outcome, objective response rate, at 6 and 12 months after treatment begins.

Efficacy and Safety Evaluation of VS-101 in Combination With Chemoradiotherapy in Patients With Head and Neck Cancer