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

Phase 2RecruitingNCT05930665

Sun Yat-sen University38 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pleural Mesothelioma

Interventions

Cadonilimab+Bevacizumab+Pemetrexed+CarboplatinDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: 1. Histologically confirmed pleural malignant mesothelioma not eligible for curative surgery 2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 3. No previous systemic anti-tumor treatment for advanced/metastatic disease 4. Measurable disease as per mRECIST v1.1 for assessment of response in malignant pleural mesothelioma. 5. Adequate haematological, renal and liver function. Key Exclusion Criteria: 1. Primitive peritoneal, pericardial and tunica vaginalis testis mesothelioma. 2. Active, untreated central nervous system (CNS) metastasis. 3. Use of Chinese herbal medicine or immunomodulatory agents with anti-tumor indications within 14 days prior to the first dose of study treatment. 4. Known active autoimmune diseases. 5. Presence of other uncontrolled serious medical conditions.

Locations (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: Up to 36 months

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Up to 36 months

Adverse Events (AEs)

Time frame: Up to 36 months

Central Contacts

Wenfeng Fang, MD

CONTACT

+86-15322302066 fangwf@sysucc.org.cn

Data from ClinicalTrials.gov

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