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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2026-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Pleural Mesothelioma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cadonilimab+Bevacizumab+Pemetrexed+Carboplatin

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

Group Type EXPERIMENTAL

Cadonilimab+Bevacizumab+Pemetrexed+Carboplatin

Intervention Type 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

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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AK104

Eligibility Criteria

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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.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No