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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

Brief 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.

Tracking Information
First Received DateAugust 31, 2016
Last Changed DateNovember 6, 2017
Start DateOctober 25, 2016
Anticipated Primary Completion DateOctober 4, 2020
Primary Outcome Measures

Overall Survival (OS) [Time Frame: 3.5 years]

Progression Free Survival (PFS) [Time Frame: 3.5 years]

Secondary Outcome Measures

Objective Response Rate (ORR) [Time Frame: 3 years]

Disease Control Rate (DCR) [Time Frame: 3 years]

Composite correlation of PD-L1 expression level and efficacy [Time Frame: 3 years]

Descriptive Information
PhasePhase 3
Study TypeInterventional
Condition
  • Mesothelioma
Intervention
  • Biological: Nivolumab
  • Biological: Ipilimumab
  • Drug: Pemetrexed
  • Drug: Cisplatin
  • Drug: Carboplatin
Study Arms / Comparison Groups2 / 0
Recruitment Information
Recruitment StatusRecruiting
Anticipated Enrollment600
GenderAll
Ages18 Years - N/A
Accepts Healthy VolunteersNo
Contact Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email:
Email: Clinical.Trials@bms.com
Eligibility Criteria

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

Administrative Information
NCTIDNCT02899299
Responsible Party,
SponsorBristol-Myers Squibb
Verification DateNovember 2017
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