Clinical Trial

A Phase III, Randomized, Open-Label, Multi-Center, Global Study of Volrustomig as Sequential Therapy Versus Observation in Participants with Unresected Locally Advanced-Head and Neck Squamous Cell Carcinoma (LA-HNSCC) Who Have Not Progressed Following Definitive Concurrent Chemoradiotherapy  (eVOLVE-HNSCC)

MOA: Checkpoint inhibitor Volrustomig (MEDI5752): Monovalent, bispecific, anti-PD-1 / anti-CTLA-4 humanized IgG1 mAb

Key Eligibility Criteria:

• Locally advanced squamous cell carcinoma of the OP, HP, OC, or LX with no evidence of metastatic disease
• Confirmed unresected Stage III-IVA/B
• SOC cCRT with curative intent completed within 12 weeks prior to randomization
• Have not progressed following cCRT with curative intent
• PD-L1 confirmation by central lab prior to randomization
• Tissue acquired <3mo. prior to cCRT or fresh tumor biopsy
• PD-L1 CPS<1 capped at 20% of randomized participants
• OPC only: confirmation of HPV status by local CINtec
  Histology p16 Assay or by central lab