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A randomized, open-label, multicenter Phase 2 trial, evaluating abi-suva in combination with MSD's anti-PD-1 therapy, pembrolizumab (KEYTRUDA) versus pembrolizumab alone as first-line treatment for human papilloma virus (HPV)16-positive, PD-L1-positive recurrent or metastatic head and neck squamous cell carcinoma (1L r/m HNSCC).

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Trial Profile

A randomized, open-label, multicenter Phase 2 trial, evaluating abi-suva in combination with MSD's anti-PD-1 therapy, pembrolizumab (KEYTRUDA) versus pembrolizumab alone as first-line treatment for human papilloma virus (HPV)16-positive, PD-L1-positive recurrent or metastatic head and neck squamous cell carcinoma (1L r/m HNSCC).

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 15 Sep 2026

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At a glance

Most Recent Events

  • 26 Aug 2026 According to a Nykode Therapeutics media release, the enrollment has expanded across additional sites in the UK, Spain and France.
  • 26 Aug 2026 Status changed from planning to recruiting, according to a Nykode Therapeutics media release.
  • 26 Aug 2026 According to a Nykode Therapeutics media release, first patient dosed in the Abili-T trial in May 2026 and the trial continues to progress according to plan, with the first interim readout expected in 2027. The marking a pivotal milestone in the company's clinical development program and reinforcing its strategy to advance abi-suva as a targeted immunotherapy for HPV16-driven cancers with significant unmet medical need.

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