Study of Cadonilimab Combined With Bevacizumab and Standard Chemotherapy as First Line Therapy in Unresectable Pleural Mesothelioma

Study Overview
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Brief Summary
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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.

Official Title
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A Phase II, Prospective, Single Arm Trial of Cadonilimab in Combination With Bevacizumab and Standard Chemotherapy as First Line Therapy in Unresectable Pleural Mesothelioma

Conditions
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Pleural Mesothelioma

Intervention / Treatment
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* Drug: Cadonilimab+Bevacizumab+Pemetrexed+Carboplatin


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: 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. Key Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cadonilimab+Bevacizumab+Pemetrexed+Carboplatin<br>Cadonilimab+Bevacizumab+Pemetrexed+Carboplatin for 4 to 6 cycles, followed by Maintenance with Cadonilimab and Bevacizumab | Drug: Cadonilimab+Bevacizumab+Pemetrexed+Carboplatin<br>* 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<br>* Other names: AK104;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bispecific antibody