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Study identifier: NCT06601335 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Head and Neck Squamous Cell Carcinoma  ·  Sponsor: Akeso

PhasePhase 3
Planned participants510
Who can joinAll sexes, 18 Years to 75 Years
Healthy volunteersNo

About this study

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 \[Combined Positive Score (CPS) greater than or equal to 1\].

This description comes directly from the study's public registry record.

Talk to the study team

Wenting Li  ·  18116403289  ·  wenting01.li@akesobio.com

Always discuss trial participation with your own doctor first.

Locations (2)

Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyWuhan, Hubei, ChinaRecruiting
West China Hospital of Sichuan UniversityChengdu, Sichuan, ChinaRecruiting

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Source record: clinicaltrials.gov/study/NCT06601335