Combining cadonilimab with bevacizumab and chemotherapy for treating unresectable pleural mesothelioma
A Phase II, Prospective, Single Arm Trial of Cadonilimab in Combination With Bevacizumab and Standard Chemotherapy as First Line Therapy in Unresectable Pleural Mesothelioma
This study is testing a new combination of cadonilimab, bevacizumab, and chemotherapy to see if it can help people with advanced pleural mesothelioma feel better and improve their treatment outcomes.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 38 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | Cadonilimab, bevacizumab, chemotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT05930665 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy and safety of cadonilimab, a bispecific antibody targeting PD-1 and CTLA-4, when combined with bevacizumab and standard chemotherapy in patients with unresectable pleural mesothelioma. The goal is to improve treatment outcomes while enhancing safety compared to traditional combination therapies. Participants will receive cadonilimab alongside bevacizumab, pemetrexed, and carboplatin as their first-line treatment. The study aims to assess measurable disease response and overall patient health.
Who should consider this trial
Good fit: Ideal candidates include individuals with histologically confirmed unresectable pleural malignant mesothelioma and an ECOG performance status of 0 or 1.
Not a fit: Patients with other types of mesothelioma, active CNS metastasis, or uncontrolled serious medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective and safer option for patients with unresectable pleural mesothelioma.
How similar studies have performed: While the combination of PD-1 and CTLA-4 therapies has shown promise in other studies, the specific approach of using cadonilimab in this context is novel.
Eligibility criteria
Show full inclusion / 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.
Where this trial is running
Guangzhou, Guangdong
- Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Wenfeng Fang, MD
- Email: fangwf@sysucc.org.cn
- Phone: +86-15322302066
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.