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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cadonilimab+Bevacizumab+Pemetrexed+Carboplatin | Experimental | Cadonilimab+Bevacizumab+Pemetrexed+Carboplatin for 4 to 6 cycles, followed by Maintenance with Cadonilimab and Bevacizumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cadonilimab+Bevacizumab+Pemetrexed+Carboplatin | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | 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. | Up to 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | defined as the time between the date of first dose of study drug and the date of first documented tumor progression per mRECIST v1.1, or death due to any cause, whichever occurs first. | Up to 36 months |
| Disease Control Rate (DCR) |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenfeng Fang, MD | Contact | +86-15322302066 | fangwf@sysucc.org.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | China |
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defined as the percentage of participants who achieve a best overall response of complete response, partial response, or stable disease assessed according to mRECIST v1.1 for assessment of response in malignant pleural mesothelioma. |
| Up to 36 months |
| Duration of Response (DoR) | defined as the interval from the date of first documentation of objective response (complete response or partial response, according to the mRECIST v1.1) to the date of first documented tumor progression, or death due to any cause, whichever occurs first. | Up to 36 months |
| Overall Survival (OS) | defined as the time between the date of first dose of study drug and the date of death due to any cause. | Up to 36 months |
| Adverse Events (AEs) | Up to 36 months |
| ID | Term |
|---|---|
| D000086002 | Mesothelioma, Malignant |
| ID | Term |
|---|---|
| D008654 | Mesothelioma |
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018301 | Neoplasms, Mesothelial |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D010997 | Pleural Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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