Study Comparing Ivonescimab Alone or Ivonescimab in Combination With Ligufalimab Versus Pembrolizumab for the Treatment of SCCHN
A Randomized, Open-label, Multicenter, Phase 3 Trial of Ivonescimab Alone or With Ligufalimab Versus Pembrolizumab in First-line Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)
Sponsor: Groupe Oncologie Radiotherapie Tete et Cou + Akeso Biopharma Co., Ltd., Summit Therapeutics
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Overall survival
Time frame: From the date of randomization to the date of death from any cause up to 54 months
Eligibility Criteria
Inclusion Criteria: 1. Patient capable of voluntary giving her/his written informed consent. 2. Age ≥ 18 and \< 80 years old at the time of enrolment. 3. Eastern Cooperative Oncology Organization (ECOG) performance status score of 0 or 1. 4. Expected survival ≥ 6 months at randomization. 5. Patient is histologically and/or cytologically confirmed to have r/m HNSCC (according to the International Union Against Cancer and the American Joint Committee on Cancer 8th edition staging system) with a primary tumour initially or currently located in the oral cavity, oropharynx, hypopharynx, or larynx. 6. HPV status test results based on tumour tissue samples must be obtained prior to randomization for patients with oropharyngeal cancer. 7. No prior systemic anti-tumour therapy for R/M HNSCC. Note: Patients who have previously received adjuvant/neoadjuvant chemotherapy with curative intent for non-metastatic disease, radiotherapy, or radical radiotherapy in combination with chemotherapy or cetu…
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