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

Source: https://onco.cc/trials/nct06601335/  
OnCo record `nct06601335` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Trial
- Status: recruiting
- Last checked: 2026-09-11
- Tags: ctgov-ingest
- Registry id: 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
- Enrolled: 510

## Sources

- ClinicalTrials.gov NCT06601335: https://clinicaltrials.gov/study/NCT06601335

## Connected records

- cancers: [Head and neck squamous cell carcinoma](https://onco.cc/cancers/head-and-neck/), [Recurrent or metastatic head and neck squamous cell carcinoma](https://onco.cc/cancers/recurrent-metastatic-hnscc/)
- drugs: [AK117](https://onco.cc/drugs/ak117/)
- companies: [Akeso](https://onco.cc/companies/akeso/)

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