Study of Cadonilimab Combined With Bevacizumab and Standard Chemotherapy as First Line Therapy in Unresectable Pleural Mesothelioma
A Phase II, Prospective, Single Arm Trial of Cadonilimab in Combination With Bevacizumab and Standard Chemotherapy as First Line Therapy in Unresectable Pleural Mesothelioma
Sun Yat-sen University
38 participants
Nov 1, 2023
INTERVENTIONAL
Conditions
Summary
Cadonilimab, a tetravalent bispecific antibody targeting PD-1 and CTLA-4, is designed to retain the efficacy benefit of combination of PD-1 and CTLA-4 and improve on the safety profile of the combination therapy. The aim of this study is to evaluate the efficacy and safety of cadonilimab in combination with bevacizumab and standard chemotherapy as first Line therapy in unresectable pleural mesothelioma.
Eligibility
Inclusion Criteria5
- Histologically confirmed pleural malignant mesothelioma not eligible for curative surgery
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- No previous systemic anti-tumor treatment for advanced/metastatic disease
- Measurable disease as per mRECIST v1.1 for assessment of response in malignant pleural mesothelioma.
- Adequate haematological, renal and liver function.
Exclusion Criteria5
- Primitive peritoneal, pericardial and tunica vaginalis testis mesothelioma.
- Active, untreated central nervous system (CNS) metastasis.
- Use of Chinese herbal medicine or immunomodulatory agents with anti-tumor indications within 14 days prior to the first dose of study treatment.
- Known active autoimmune diseases.
- Presence of other uncontrolled serious medical conditions.
Interventions
Cadonilimab 10mg/kg intravenous (IV) every 3 weeks + Bevacizumab 7.5mg/kg IV every 3 weeks + Pemetrexed 500 mg/m² IV every 3 weeks + Carboplatin AUC 5 IV every 3 weeks for 4 to 6 cycles, followed by maintenance with Cadonilimab 10mg/kg IV every 3 weeks + Bevacizumab 7.5mg/kg IV every 3 weeks
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05930665