{"entity":{"id":"nct06601335","kind":"trial","name":"A Phase 3 Study of AK112 Plus AK117 Versus Pembrolizumab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC)","aka":[],"tldr":"A phase 3 trial testing AK117 in head and neck squamous cell carcinoma, now recruiting.","summary":"A Phase 3 Study of AK112 Plus AK117 Versus Pembrolizumab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) is a phase 3 interventional study registered as NCT06601335, led by Akeso, and recruiting on the registry. Official title: A Randomised, 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). Planned enrolment is 510 participants (estimated). The study started in 2024-10-30 and primary completion is expected in 2027-01. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06601335","url":"https://clinicaltrials.gov/study/NCT06601335"}],"tags":["ctgov-ingest"],"related":[],"cancers":["head-and-neck","recurrent-metastatic-hnscc"],"sections":[],"technologies":[],"targets":[],"drugs":["ak117"],"companies":["akeso"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06601335","phase":"3","setting":"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)","sponsor":"Akeso","started":"2024-10-30","startedType":"actual","enrolled":510,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct06601335/","neighbours":{"cancer":[{"id":"head-and-neck","kind":"cancer","name":"Head and neck squamous cell carcinoma","route":"/cancers/head-and-neck/"},{"id":"recurrent-metastatic-hnscc","kind":"cancer","name":"Recurrent or metastatic head and neck squamous cell carcinoma","route":"/cancers/recurrent-metastatic-hnscc/"}],"drug":[{"id":"ak117","kind":"drug","name":"AK117","route":"/drugs/ak117/"}],"company":[{"id":"akeso","kind":"company","name":"Akeso","route":"/companies/akeso/"}]}}