Study of Nivolumab Combined With Ipilimumab Versus Pemetrexed and Cisplatin or Carboplatin as Fir… (NCT02899299) | Clinical Trial Compass
CompletedPhase 3
Study of Nivolumab Combined With Ipilimumab Versus Pemetrexed and Cisplatin or Carboplatin as First Line Therapy in Unresectable Pleural Mesothelioma Patients
United States605 participantsStarted 2016-11-29
Plain-language summary
The purpose of this study is to test the effectiveness and tolerability of the combination of Nivolumab and Ipilimumab compared to Pemetrexed and Cisplatin or Carboplatin in patients with unresectable pleural mesothelioma.
Who can participate
Age range18 Years
SexALL
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For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
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
Other protocol defined inclusion/exclusion criteria could apply
What they're measuring
1
Overall Survival (OS)
Timeframe: From randomization to the date of death (Up to 40 Months)