Primary Outcome Measures
- Overall Survival (OS) [ Time Frame: 3.5 years ] [ Designated as safety issue: Yes ]
- Progression Free Survival (PFS) [ Time Frame: 3.5 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures
- Objective Response Rate (ORR) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Disease Control Rate (DCR) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Composite correlation of PD-L1 expression level and efficacy [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Efficacy determined by the ORR, PFS, and OS
Eligibility
- Inclusion Criteria
- Males and Females at least 18 years of age
- Histologically confirmed pleural malignant mesothelioma not eligible for curative surgery
- ECOG Performance status of 0 or 1
- Available tumor sample for testing
- Acceptable blood work
- Exclusion Criteria
- Primitive peritoneal, pericardial and tunica vaginalis testis mesotheliomas
- Prior chemotherapy for pleural mesothelioma
- Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2 oranti-CTLA-4 antibody
- History of other malignancy unless the subject has been disease-free for at least 3 years
- Active, untreated central nervous system (CNS) metastasis
