Pleural Mesothelioma
Conditions
Keywords
bispecific antibody
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.
Interventions
DRUGCadonilimab+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
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | Up to 36 months | defined as the percentage of participants who achieve a best overall response of complete response or partial response assessed according to mRECIST v1.1 for assessment of response in malignant pleural mesothelioma. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) | Up to 36 months | defined as the time between the date of first dose of study drug and the date of first documented tumor progression per mRECIST v1.1, or death due to any cause, whichever occurs first. |
| Disease Control Rate (DCR) | Up to 36 months | defined as the percentage of participants who achieve a best overall response of complete response, partial response, or stable disease assessed according to mRECIST v1.1 for assessment of response in malignant pleural mesothelioma. |
| Duration of Response (DoR) | Up to 36 months | defined as the interval from the date of first documentation of objective response (complete response or partial response, according to the mRECIST v1.1) to the date of first documented tumor progression, or death due to any cause, whichever occurs first. |
| Overall Survival (OS) | Up to 36 months | defined as the time between the date of first dose of study drug and the date of death due to any cause. |
| Adverse Events (AEs) | Up to 36 months | — |
Countries
China
Contacts
Primary ContactWenfeng Fang, MD
Outcome results
None listed