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
Patient capable of voluntary giving her/his written informed consent.
Age ≥ 18 and < 80 years old at the time of enrolment.
Eastern Cooperative Oncology Organization (ECOG) performance status score of 0 or 1.
Expected survival ≥ 6 months at randomization.
Primary tumour site (any histology) of nasopharynx, nasal cavity, sinuses, salivary glands, thyroid or parathyroid glands, skin, or unknown primary site of tissue origin.
Patient with malignancies other than HNSCC within 3 years prior to enrolment. Patients with other tumours that have been cured through local treatment, such as basal or cutaneous squamous cell carcinoma, superficial bladder cancer, cervical or breast carcinoma in situ, are not excluded.
Concurrent enrolment in another clinical study, unless it is an observational, non-interventional clinical study or a follow-up period of an interventional study; Received study treatment within 4 weeks prior to randomization.
Prior treatment with systemic anti-angiogenic drugs.
Parallel
Ivonescimab 10 mg/kg
DrugIvonescimab 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
DrugAK117 is a humanized IgG4 mAb being investigated as a cancer immunotherapy agent
Pembrolizumab (KEYTRUDA ®)
DrugPembrolizumab 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.
Overall survival
the time from the date of randomization to the date of death from any cause. Patients still alive at the time of analysis will be censored at the date of their last known alive date
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Groupe Oncologie Radiotherapie Tete et Cou
Lead sponsor
Akeso Biopharma Co., Ltd.
Collaborator
Summit Therapeutics
Collaborator
