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

Published: 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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