Clinical Trial

A Randomized, Double-blind, Placebo-controlled Phase 3 Study to evaluate Dostarlimab as Sequential Therapy after Chemoradiation in Patients with Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma

MOA: Dostarlimab is a humanized anti-PD-1 IgG4 mAb.

Key Eligibility Criteria:

• Unresected LA histologically confirmed HNSCC of the oral cavity,
  oropharynx (OPSCC), hypopharynx or larynx
• OPSCC p16 positive: T4 (N0-N3), M0; N3 (T1-T4), M0
• OPSCC p16 negative: Any T3-T4 (N0-N3), M0; Any N2a-N3 (T1-T4), M0
• Larynx/hypopharynx/oral cavity (independent of p16): Any T3-T4 (N0-
  N3), M0; Any N2a-N3 (T1-T4), M0
• Complete CRT and no metastasis
• Prior systemic, radiation, surgery, immunotherapy or targeted
  therapy, that are not considered part of CRT, are excluded
• Has provided acceptable core or excisional biopsy
• PD-L1 positive tumor CPS ≥ 1 (central testing)
• OPSCC only: p16 IHC positive ≥ 70% (local CINtec assay)