Clinical Trial

A Phase 3 Study of AK112 Plus AK117 Versus Pembrolizumab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC)

Recruiting Phase 3
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Summary
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 \[Combined Positive Score (CPS) greater than or equal to 1\].
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-09-14.
Status change: Not Yet Recruiting → Recruiting 2024-11-13
Trial Details
NCT Number NCT06601335
Lead Sponsor Akeso
Conditions Head and Neck Squamous Cell Carcinoma
Enrollment 510 participants
Start Date 2024-10-30
Primary Completion 2027-01 (estimated)
Study Completion 2027-10 (estimated)
Updated on ClinicalTrials.gov 2024-11-14