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

NCT07264075 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 780

Last updated 2026-05-20

No results posted yet for this study

Summary

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

Conditions

  • Squamous Cell Carcinoma Head and Neck Cancer (HNSCC)

Interventions

DRUG

Ivonescimab 10 mg/kg

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.

DRUG

Ligufalimab

AK117 is a humanized IgG4 mAb being investigated as a cancer immunotherapy agent

DRUG

Pembrolizumab (KEYTRUDA ®)

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.

Sponsors & Collaborators

  • Akeso Biopharma Co., Ltd.

    collaborator UNKNOWN

  • Summit Therapeutics

    collaborator INDUSTRY

  • Groupe Oncologie Radiotherapie Tete et Cou

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-05
Primary Completion
2030-05-31
Completion
2030-05-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07264075 on ClinicalTrials.gov