OncoMatch/Clinical Trials/NCT06601335
A Phase 3 Study of AK112 Plus AK117 Versus Pembrolizumab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC)
Is NCT06601335 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies AK117 in combination with AK112 for head and neck squamous cell carcinoma.
Treatment: AK117 in combination with AK112 — 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 \[Combined Positive Score (CPS) greater than or equal to 1\].
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: PD-L1 (CD274) positive (CPS ≥ 1) (CPS ≥ 1)
PD-L1 positive (CPS ≥ 1)
Disease stage
Required: Stage IV
R/M HNSCC primarily located in oropharynx, oral cavity, hypopharynx, or larynx, which is considered incurable by local therapies.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: immunotherapy
Previously received immunotherapy, including immune checkpoint inhibitors, immune checkpoint agonists, immune cell therapy, and any other treatments targeting the immune mechanisms of tumors.
Cannot have received: radiation therapy
Exception: palliative radiation therapy for non-head or non-neck within 3 weeks prior to enrollment
Previously received radiation therapy for head or neck within 8 weeks prior to enrollment, received palliative radiation therapy for non-head or non-neck within 3 weeks prior to enrollment.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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