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

Sponsor
Groupe Oncologie Radiotherapie Tete et Cou
Study ID
NCT07264075
Phase
PHASE3
Status
Recruiting
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Conditions

  • Squamous Cell Carcinoma Head and Neck Cancer (HNSCC)

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Ivonescimab 10 mg/kg — DRUG
    Ivonescimab is a humanized immunoglobulin (Ig) G1 monoclonal antibody (mAb) being investigated as a cancer immunotherapy agent. Ivonescimab binds to human VEGF-A which is involved in tumor angiogenesis, and to human PD-1 that is a cell surface receptor expressed primarily on activated T cells and acts to inhibit T cell activation.
  • Ligufalimab — DRUG
    AK117 is a humanized IgG4 mAb being investigated as a cancer immunotherapy agent
  • Pembrolizumab (KEYTRUDA ®) — DRUG
    Pembrolizumab is a humanized monoclonal antibody (IgG4 kappa isotype with stabilizing sequence alteration in the Fc region) against PD-1 (programmed cell death-1), produced in Chinese hamster ovary cells by recombinant DNA technology.

Study Details

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

Key Dates

Start date
May 5, 2026
Status verified
May 2026
Primary completion
May 31, 2030
Completion
May 31, 2030

Study Design

Enrollment
780 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Bras A: Ivonescimab
    Ivonescimab (10 mg/kg iv, 60 min ± 10 min infusion, Q3W)
  • Experimental: Bras B: Ivonescimab - Ligufalimab
    Ivonescimab (10 mg/kg iv, 60 min ± 10 min infusion, Q3W), and ligufalimab (45 mg/kg iv, 120 min ± 15 min infusion, Q3W).
  • Active Comparator: Bras C: Pembrolizumab
    Pembrolizumab (200 mg iv, 60 min ± 10 min infusion, Q3W).

Primary Outcome Measure

Overall survival [ Time Frame: From the date of randomization to the date of death from any cause up to 54 months ]

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