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

Completed · Phase 3

Conditions studied: Mesothelioma

In brief

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.

Key facts

Study ID

NCT02899299

Run by

Bristol-Myers Squibb

People needed

605

Starts

2016-11-29

Expected to finish

2023-04-28

Last updated by the study team

2024-05-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Local Institution - 0014 — New Haven, Connecticut, United States
• H. Lee Moffitt Cancer Center & Research Inst, Inc — Tampa, Florida, United States
• Local Institution - 0002 — Chicago, Illinois, United States
• Univ Of Maryland Greenbaum Cancer Center — Baltimore, Maryland, United States
• Local Institution - 0013 — Detroit, Michigan, United States
• Cancer & Hematology Centers Of Western Michigan — Grand Rapids, Michigan, United States
• Local Institution - 0004 — Rochester, Minnesota, United States
• Memorial Sloan Kettering Nassau — New York, New York, United States
• Local Institution - 0007 — Cleveland, Ohio, United States
• University Of Pennsylvania — Philadelphia, Pennsylvania, United States
• Allegheny Cancer Center — Pittsburgh, Pennsylvania, United States
• Local Institution - 0005 — Houston, Texas, United States
• West Virginia University — Morgantown, West Virginia, United States
• Local Institution - 0032 — Sydney, New South Wales, Australia
• Local Institution - 0031 — Birtinya, Queensland, Australia
• Local Institution - 0033 — Clayton, Victoria, Australia
• Local Institution - 0030 — Malvern, Victoria, Australia
• Local Institution - 0034 — Nedlands, Western Australia, Australia
• Local Institution - 0089 — Brussels, Belgium
• Local Institution - 0086 — Edegem, Belgium
• Local Institution - 0087 — Liège, Belgium
• Local Institution - 0088 — Sint-Niklaas, Belgium
• Local Institution — Barretos, São Paulo, Brazil
• Local Institution - 0064 — São Paulo, Brazil
• Ucsf — San Francisco, California, United States

Full record on ClinicalTrials.gov

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