A Phase 2/3, Randomized, Open-label Study to Compare Bempegaldesleukin Combined with Pembrolizumab Versus Pembrolizumab Alone in First-Line Treatment of Patients with Metastatic or Recurrent Head and Neck Squamous-Cell Carcinoma with PD-L1 Expressing Tumors (PROPEL-36)
To compare the overall survival and the objective response rate of bempegaldesleukin plus pembrolizumab vs. pembrolizumab monotherapy.
DiagnosisPatients with recurrent or metastatic head and neck squamous-cell carcinoma
Metastatic/recurrent Head oropharynx
Patients with oral cavity, hypopharynx, and larynx SCC.
No prior therapy in metastatic/recurrent setting
Patients must sign an approved informed consent and authorization permitting release of personal health information.
Group 1: Bempegaldesleukin plus pembrolizumab every three weeks for up to 35 cycles
Group 2: Pembrolizumab monotherapy every 3 weeks for up to 35 cycles
For more information, visit Clinicaltrials.gov