A Phase II, Prospective, Single Arm Trial of Cadonilimab in Combination With Bevacizumab and Standard Chemotherapy as First Line Therapy in Unresectable Pleural Mesothelioma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed pleural malignant mesothelioma not eligible for curative surgery
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or
- •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.
排除标准
- •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.
研究组 & 干预措施
Cadonilimab+Bevacizumab+Pemetrexed+Carboplatin
Cadonilimab+Bevacizumab+Pemetrexed+Carboplatin for 4 to 6 cycles, followed by Maintenance with Cadonilimab and Bevacizumab
干预措施: Cadonilimab+Bevacizumab+Pemetrexed+Carboplatin (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: Up to 36 months
defined as the percentage of participants who achieve a best overall response of complete response or partial response assessed according to mRECIST v1.1 for assessment of response in malignant pleural mesothelioma.
次要结局
- Progression Free Survival (PFS)(Up to 36 months)
- Disease Control Rate (DCR)(Up to 36 months)
- Duration of Response (DoR)(Up to 36 months)
- Overall Survival (OS)(Up to 36 months)
- Adverse Events (AEs)(Up to 36 months)
研究者
Wenfeng Fang
chief physician
Sun Yat-sen University