Overview

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

Status:
NOT_YET_RECRUITING

Trial end date:
2030-05-01

Target enrollment:

Participant gender:

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

Phase:

PHASE3

Details

Lead Sponsor:

Groupe Oncologie Radiotherapie Tete et Cou

Collaborators:

Akeso Biopharma Co., Ltd.
Summit Therapeutics

Treatments:

pembrolizumab