Study of Cadonilimab Combined With Chemotherapy in Recurrent /​ Refractory Pleural Mesothelioma

May 17, 2024

Primary Outcome Measures

  • Objective Response Rate (ORR)

Secondary Outcome Measures

  • Disease Control Rate (DCR)
  • Progression Free Survival (PFS)
  • Duration of Response (DoR)
  • Overall Survival (OS)
  • Adverse Events (AEs)

Inclusion Criteria

  1. Histologically confirmed advanced or metastatic pleural mesothelioma;
  2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  3. Participants must have previously failed to receive platinum-containing chemotherapy with or without bevacizumab, and have received at most two-line systemic therapy.
  4. Measurable disease as per mRECIST v1.1 for assessment of response in malignant pleural mesothelioma.
  5. Adequate haematological, renal and liver function.

Exclusion Criteria

  1. Primary mesothelioma of peritoneum, pericardium and testes
  2. Active, untreated central nervous system (CNS) metastasis.
  3. Use of Chinese herbal medicine or immunomodulatory agents with anti-tumor indications within 14 days prior to the first dose of study treatment.
  4. Known active autoimmune diseases.
  5. Presence of other uncontrolled serious medical conditions.
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