unresectable pleural or peritoneal malignant mesothelioma
Conditions
Brief summary
The primary endpoint is OS which is defined as the time from randomization until death due to any cause.
Detailed description
The secondary efficacy endpoints include OS rate at 18 months, PRO as well as durable DCR, PFS, ORR, and duration of response, based on modified Response Evaluation Criteria in Solid Tumors (RECIST) for pleural mesothelioma and RECIST criteria v1.1 for peritoneal mesothelioma., The safety endpoints include adverse events (AEs) and serious adverse events (SAEs), changes from baseline in clinical laboratory evaluations, electrocardiograms (ECGs), and vital signs. Adverse events and SAEs will be assessed for severity and relationship to investigational product., The immunogenic potential of tremelimumab will be analyzed and the pharmacokinetics of tremelimumab will be assessed.
Interventions
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is OS which is defined as the time from randomization until death due to any cause. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary efficacy endpoints include OS rate at 18 months, PRO as well as durable DCR, PFS, ORR, and duration of response, based on modified Response Evaluation Criteria in Solid Tumors (RECIST) for pleural mesothelioma and RECIST criteria v1.1 for peritoneal mesothelioma., The safety endpoints include adverse events (AEs) and serious adverse events (SAEs), changes from baseline in clinical laboratory evaluations, electrocardiograms (ECGs), and vital signs. Adverse events and SAEs will be assessed for severity and relationship to investigational product., The immunogenic potential of tremelimumab will be analyzed and the pharmacokinetics of tremelimumab will be assessed. | — |
Countries
Italy
Outcome results
None listed