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

Phase 2

Recruiting

• Conditions: Pleural Mesothelioma
• Interventions: Drug: Cadonilimab+Bevacizumab+Pemetrexed+Carboplatin

• Registration Number: NCT05930665
• Lead Sponsor: Sun Yat-sen University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-26
• Study First Submitted QC: 2023-07-03
• Study First Posted: 2023-07-05
• Study Start: 2023-11-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-19
• Last Update Posted: 2024-02-21
• Primary Completion: 2025-07
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 38

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cadonilimab+Bevacizumab+Pemetrexed+Carboplatin	Cadonilimab+Bevacizumab+Pemetrexed+Carboplatin	Cadonilimab+Bevacizumab+Pemetrexed+Carboplatin for 4 to 6 cycles, followed by Maintenance with Cadonilimab and Bevacizumab

Primary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	Up to 36 months	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.

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS)	Up to 36 months	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.
Disease Control Rate (DCR)	Up to 36 months	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.
Duration of Response (DoR)	Up to 36 months	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.
Overall Survival (OS)	Up to 36 months	defined as the time between the date of first dose of study drug and the date of death due to any cause.
Adverse Events (AEs)	Up to 36 months

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China