Study Comparing Ivonescimab Alone or Ivonescimab in Combination With Ligufalimab Versus Pembrolizumab for the Treatment of SCCHN

This is a randomized, open-label, active-comparator-controlled, multi-regional, three-arm, phase 3 study comparing the efficacy and safety of ivonescimab in combination with ligufalimab to pembrolizumab and of ivonescimab alone to pembrolizumab as first-line treatment in patients with recurrent or metastatic (R/M) PD-L1-positive squamous cell carcinoma of the head and neck (HNSCC). The objective of this study is to improve first-line survival in patients with recurrent or metastatic PD-L1-positive HNSCC (CPS ≥ 1). Overall survival (OS) was chosen as the primary endpoint. Patients will receive the following treatment regimens in accordance with the study treatment plan until disease progression, death, intolerable toxicity, or the occurrence of another protocol-specified treatment discontinuation criterion, whichever occurs first. * ARM A: Ivonescimab (10 mg/kg iv, 60 min ± 10 min infusion, Q3W) * ARM B: Ivonescimab (10 mg/kg iv, 60 min ± 10 min infusion, Q3W), and ligufalimab (45 mg/kg iv, 120 min ± 15 min infusion, Q3W). * ARM C (control arm): Pembrolizumab (200 mg iv, 60 min ± 10 min infusion, Q3W). The total duration of treatment is up to 24 months

NCT Number	NCT07264075
Lead Sponsor	Groupe Oncologie Radiotherapie Tete et Cou Collaborators: Akeso Biopharma Co., Ltd., Summit Therapeutics
Conditions	Squamous Cell Carcinoma Head and Neck Cancer (HNSCC)
Enrollment	780 participants
Start Date	2026-05-05
Primary Completion	2030-05 (estimated)
Study Completion	2030-05 (estimated)
Updated on ClinicalTrials.gov	2026-05-20