Study of Nivolumab Combined With Ipilimumab Versus Pemetrexed and Cisplatin or Carboplatin as First Line Therapy in Unresectable Pleural Mesothelioma Patients

December 21, 2016

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

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