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

Name: A Phase 3 Study of AK112 Plus AK117 Versus Pembrolizumab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) — clinical trial record (NCT06601335)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

StatusRecruiting

PhasePhase 3

SponsorAkeso

Started2024-10-30

View on ClinicalTrials.gov ↗

Amendment history

2024-11-13

Not Yet Recruiting→Recruiting Study Identification, Study Status, Oversight, Contacts/Locations v1

Trial statusNot Yet Recruiting→Recruiting

Start dateestimated 2024-10→confirmed 2024-10-30

Study sitesdetails revised at 2 of 2 sites

2024-09-14

Original filing

Akeso

96 trials monitored

See 1 trial at risk

Head & Neck Cancer

2,051 trials monitored

See 116 trials at risk

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

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