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A Randomized, Controlled, Multicenter Phase 3 Study of AK112 in Combination With AK117 Versus Pembrolizumab as First Line Treatment for a Programmed Cell Death-ligand 1 (PD-L1) Positive Population With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC)
This is a phase 3 study. All subjects arerecurrent or metastatic head and neck squamous Cell Carcinoma (R/M HNSCC), Eastern Cooperative Oncology Group (ECOG) performance status 0-1. The purpose of this study is to evaluate the efficacy and safety of AK112 combined with AK117 versus pembrolizumab combined with placebo in patients with R/M HNSCC whose tumors have programmed cell death-ligand 1 (PD-L1) positive \[Combined Positive Score (CPS) greater than or equal to 1\].
Details
| Lead sponsor | Akeso |
|---|---|
| Phase | Phase 3 |
| Status | RECRUITING |
| Enrolment | 510 |
| Start date | 2024-10-30 |
| Completion | 2027-10 |
Conditions
- Head and Neck Squamous Cell Carcinoma
Interventions
- AK117 in combination with AK112
- Placebo in combination with Pembrolizumab
Primary outcomes
- Overall Survival (OS) — Up to approximately 2 years
OS is the time from randomization to death due to any cause.
Countries
China