Study of Cadonilimab Combined With Chemotherapy in Recurrent / Refractory Pleural Mesothelioma

Launched by CANCER INSTITUTE AND HOSPITAL, CHINESE ACADEMY OF MEDICAL SCIENCES · May 12, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with recurrent or hard-to-treat pleural mesothelioma, a type of cancer that affects the lining of the lungs. Researchers are looking at how well a medication called Cadonilimab works when combined with certain chemotherapy drugs, such as gemcitabine, vinorelbine, or pemetrexed. This study is in Phase II, which means it aims to find out if the treatment is safe and effective for patients who have already tried other treatments that didn't work.

To be eligible for this trial, participants need to have a confirmed diagnosis of advanced pleural mesothelioma and a good performance status, meaning they can carry out daily activities with minimal assistance. They should also have already received platinum-based chemotherapy and no more than two prior treatments. Participants will be monitored for their health and how well their disease responds to the new treatment. It's important to note that this trial is not yet recruiting patients, and there are specific health conditions that may prevent someone from participating, such as active central nervous system metastasis or other serious medical issues.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Histologically confirmed advanced or metastatic pleural mesothelioma;
• • 2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
• • 3. Participants must have previously failed to receive platinum-containing chemotherapy with or without bevacizumab, and have received at most two-line systemic therapy.
• • 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. Primary mesothelioma of peritoneum, pericardium and testes
• • 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.