Efficacy and Safety Evaluation of VS-101 in Combination With Chemoradiotherapy in Patients With Head and Neck Cancer
Trial Parameters
Brief Summary
This will be a multi-center, randomized, open-label, parallel-group study in adult patients with head and neck cancer.
Eligibility Criteria
Inclusion Criteria: 1. Males or females aged more than 18 years at the time of ICF signing 2. Diagnosed based on position emission tomography (PET), computed tomography (CT), or magnetic resonance imaging (MRI) with pathologically confirmed (histologic or cytological) head and neck squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx 3. Defined by American Joint Committee on Cancer \[AJCC\] Guidelines 8th Edition: * Oral cavity, hypopharynx, or larynx (independent of p16): Stage III, IVa, IVb per TNM guidelines; or * Oropharyngeal p16 negative disease: Stage III, IVa, IVb per TNM guidelines; or * Oropharyngeal p16 positive disease: T4 (N0-N3), M0; or N3 (T1-T4), M0. 4. Have measurable disease based on RECIST 1.1 5. Subjects with head and neck cancer who have limited to those receiving definitive CRT without surgical excision 6. Subjects prescribed standard intensity-modulated radiation therapy (IMRT) with daily fractions of 2.0 Gy to a cumulative planned dose