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Protocol No.16100GCCPrincipal InvestigatorZandberg, Dan
PhasePhase III
Age GroupAdult
Title16100GCC: A Phase III, Randomized, Open Label Trial of Nivolumab in combination with Ipilimumab versus Pemetrexed with Cisplatin or Carboplatin as First Line Therapy in unresectable Pleural Mesothelioma [CA209-743]
DescriptionThe purpose of this study is to test the combination of nivolumab + ipilimumab compared to standard chemotherapy (pemetrexed + cisplatin OR pemetrexed + carboplatin) in people with malignant pleural mesothelioma.

About 600 people will take part in this study worldwide. About 100 of those people will be in the US. Patients will be assigned by chance to either treatment Arm A (nivolumab + ipilimumab) or Arm B (pemetrexed + cisplatin OR pemetrexed + carboplatin).

Patients assigned to Arm A will receive nivolumab every two weeks and ipilimumab every six weeks up to 6 cycles until disease progression and/or toxicity. Patients assigned to Arm B will receive treatment (pemetrexed + cisplatin OR pemetrexed + carboplatin) every three weeks.
TreatmentPatients will be assigned by chance to either treatment Arm A (nivolumab + ipilimumab) or Arm B (pemetrexed + cisplatin OR pemetrexed + carboplatin).
Key EligibilityFor more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:
-At least 18 years of age
-Diagnosis of malignant pleural mesothelioma (MPM)
-Available fresh or archived tumor sample for testing
-Measurable disease via m-RECIST
-Acceptable blood work

Exclusion Criteria:
-Primitive peritoneal, pericardial, testis or tunica vaginalis mesotheliomas
-Prior chemotherapy for pleural mesothelioma
-Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2 or anti-CTLA-4 antibody
-Active, untreated central nervous system (CNS) metastasis

Other protocol defined inclusion/exclusion criteria could apply.
Applicable Disease SitesLung
Therapies InvolvedChemotherapy (NOS)
Immunotherapy
Drugs InvolvedIpilimumab (MDX-010
BMS-734016)
Nivolumab
Pemetrexed
carboplatin
cisplatin
StatusOpen
Treatment TypeTreatment
ClinicalTrials.gov http://www.clinicaltrials.gov/ct2/show/NCT02899299
ContactGreenebaum Cancer Center Maha Khalil, PhD Phone:410-328-5009
Pager:
Email:mkhalil@umm.edu
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