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

NCT05930665 | Recruiting Phase 2

• 1 other identifier: AK104-IIT-028
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Pleural Mesothelioma

Keywords

bispecific antibody

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Progression Free Survival (PFS)

  Up to 36 months

• Disease Control Rate (DCR)

  Up to 36 months

• Duration of Response (DoR)

  Up to 36 months

• Overall Survival (OS)

  Up to 36 months

• Adverse Events (AEs)

  Up to 36 months

Study Arms (1)

Cadonilimab+Bevacizumab+Pemetrexed+Carboplatin

EXPERIMENTAL

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

Drug: Cadonilimab+Bevacizumab+Pemetrexed+Carboplatin

Interventions

Cadonilimab+Bevacizumab+Pemetrexed+Carboplatin DRUG

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

Also known as: AK104

Cadonilimab+Bevacizumab+Pemetrexed+Carboplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Mesothelioma, Malignant

Condition Hierarchy (Ancestors)

Mesothelioma; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Pleural Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Wenfeng Fang, MD

CONTACT

+86-15322302066; fangwf@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: June 26, 2023
• First Posted: July 5, 2023
• Study Start: November 1, 2023
• Primary Completion: July 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 21, 2024

Record last verified: 2024-02

Locations

CN (1)