RecruitingPhase 2NCT05930665

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


Sponsor

Sun Yat-sen University

Enrollment

38 participants

Start Date

Nov 1, 2023

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding cadonilimab (an immunotherapy drug) to standard chemotherapy plus bevacizumab improves outcomes as a first-line treatment for people with malignant pleural mesothelioma — a rare cancer of the lining of the lungs — that cannot be surgically removed. **You may be eligible if...** - You have confirmed malignant pleural mesothelioma that is not eligible for curative surgery - You have not previously received systemic treatment for advanced disease - You have measurable disease on imaging - Your general health score (ECOG) is 0 or 1 - Your blood counts and organ function are adequate **You may NOT be eligible if...** - Your mesothelioma is in the abdomen, around the heart, or in the testicular lining (not pleural) - You have untreated brain metastases - You have an active autoimmune disease - You have serious uncontrolled medical conditions - You used traditional Chinese herbal medicine or immune-modulating agents recently Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCadonilimab+Bevacizumab+Pemetrexed+Carboplatin

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)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

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NCT05930665


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