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

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

This is a multicenter, single-arm, phase II clinical study to evaluate the safety and efficacy of Cadonilimab combined with gemcitabine, or vinorelbine, or pemetrexed in the treatment of patients with recurrent / refractory pleural mesothelioma.

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.