NCT05930665 Study of Cadonilimab Combined With Bevacizumab and Standard Chemotherapy as First Line Therapy in Unresectable Pleural Mesothelioma
| NCT ID | NCT05930665 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Sun Yat-sen University |
| Condition | Pleural Mesothelioma |
| Study Type | INTERVENTIONAL |
| Enrollment | 38 participants |
| Start Date | 2023-11-01 |
| Primary Completion | 2025-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 38 participants in total. It began in 2023-11-01 with a primary completion date of 2025-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05930665 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pleural Mesothelioma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05930665 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05930665 currently recruiting?
Yes, NCT05930665 is actively recruiting participants. Contact the research team at fangwf@sysucc.org.cn for enrollment information.
Where is the NCT05930665 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT05930665 clinical trial?
NCT05930665 is sponsored by Sun Yat-sen University. The trial plans to enroll 38 participants.