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

Pleural Mesothelioma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05930665
• Other study ID #: AK104-IIT-028
• Status: Recruiting
• Phase: Phase 2
• Start date: November 1, 2023
• Est. completion date: July 2026

Study information

• Verified date: February 2024
• Source: Sun Yat-sen University
• Contact: Wenfeng Fang, MD
• Phone: +86-15322302066
• Email: fangwf[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 38
• Est. completion date: July 2026
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Mesothelioma
• Mesothelioma, Malignant
• Pleural Mesothelioma

Intervention

Drug:
• Cadonilimab+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

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Adverse Events (AEs)		Up to 36 months