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: Volrustomig (MEDI5752) is a bispecific ab that targets PD-1 and CTLA-4.

Key Eligibility Criteria:

• Confirmed diagnosis of LA unresected HNSCC (OP, HP, OC or LX) with no
  evidence of metastatic disease
• OPC only: confirmation of HPV status by local CINtec® p16 assay
• Completed SOC cCRT with curative intent within 6 weeks (42 days) prior to
  randomization and must not have progressed
  • If all eligibility criteria are met at week 6 except for unresolved toxicities due to cCRT, pt can be rescreened and randomized up to week 8 following completion of cCRT if toxicities are resolved
  • Please consult protocol for permitted regimens
• PD-L1 status by central lab prior to randomization
  • Tissue must be collected ≤6 months prior to first dose of cCRT
  • CPS<1 capped at 20%
• Participants with a prophylactic PEG tube in place are permitted
• Untreated/progressive CNS metastases, leptomeningeal disease or cord
  compression are excluded
• Prior immune-mediated tx including, but not limited to other anti-CTLA-4,
  anti-PD-(L)1/2 antibodies are excluded