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

Sun Yat-sen University

Status and phase: Enrolling; Phase 2

Conditions: Pleural Mesothelioma

Treatments: Drug: Cadonilimab+Bevacizumab+Pemetrexed+Carboplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT05930665

AK104-IIT-028

Details and patient eligibility

About

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.

Enrollment: 38 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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38 participants in 1 patient group

Cadonilimab+Bevacizumab+Pemetrexed+Carboplatin

Experimental group

Description:

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

Treatment:

Drug: Cadonilimab+Bevacizumab+Pemetrexed+Carboplatin