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

Sponsor

Sun Yat-sen University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05930665

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pleural Mesothelioma	Drug: Cadonilimab+Bevacizumab+Pemetrexed+Carboplatin	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

38 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Jul 1, 2025

Anticipated Study Completion Date :

Jul 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cadonilimab+Bevacizumab+Pemetrexed+Carboplatin Cadonilimab+Bevacizumab+Pemetrexed+Carboplatin for 4 to 6 cycles, followed by Maintenance with Cadonilimab and Bevacizumab	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 Other Names: AK104

Arm

Intervention/Treatment

Experimental: Cadonilimab+Bevacizumab+Pemetrexed+Carboplatin

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

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

Other Names:

AK104

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Key Inclusion Criteria:

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.

Key Exclusion Criteria:

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.