Scipibaimab Combined With Tislelizumab in Patients With First-Line Treatment-Failed Recurrent/Metastatic Nasopharyngeal Carcinoma

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSun Yat-sen University

About this trial

This study aims to explore the efficacy and safety of scipibaimab combined with tislelizumab in patients with recurrent or metastatic nasopharyngeal carcinoma who have progressed after first-line therapy.

Eligibility criteria

Qualifiers

1. Histologically or cytologically confirmed with recurrent or metastatic nasopharyngeal carcinoma which is not amenable to curative treatment with surgery and/or radiation therapy.

2. Age ≥ 18 years and ≤ 75 years, both genders.

3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.

4. Life expectancy of at least 3 months.

Disqualifiers

1.Known history of hypersensitivity to any components of the Tislelizumab formulation, or other monoclonal antibody.

2.Prior therapy with any anti-interleukin-4 receptor α (IL-4Rα) monoclonal antibody, anti-IgE monoclonal antibody, or other monoclonal antibodies/biological agents.

3.There was a history of severe bleeding, and any bleeding events with a serious grade of 3 or more in CTCAE5.0 occurred within 4 weeks before screening.

4.Before treatment, MRI showed that the tumor may have invaded important blood vessels (such as enclosing the internal carotid artery / vein), nasopharyngeal necrosis, or researchers have determined that the tumor is highly likely to invade important blood vessels and cause fatal massive bleeding during treatment.

Trial design

Treatments tested in this trial

  • Tislelizumab
  • Scipibaimab

Treatment groups

37 Participants
are divided into 1 treatment group

Sponsors and collaborators

Sun Yat-sen University

Lead sponsor

Sichuan Cancer Hospital and Research Institute

Collaborator

Cancer Hospital of Guangxi Medical University

Collaborator