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

• Status: Active, not recruiting
• Trial end date: 2023-04-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Collaborator: Ono Pharmaceutical Co. Ltd
• Treatments: Antibodies, Monoclonal; Carboplatin; Cisplatin; Ipilimumab; Nivolumab; Pemetrexed

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