NCT02899299
Completed
Phase 3
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
ConditionsMesothelioma
Overview
- Phase
- Phase 3
- Intervention
- Nivolumab
- Conditions
- Mesothelioma
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 605
- Locations
- 107
- Primary Endpoint
- Overall Survival (OS)
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Nivolumab and Ipilimumab
Specified dose on specified days
Intervention: Nivolumab
Nivolumab and Ipilimumab
Specified dose on specified days
Intervention: Ipilimumab
Pemetrexed and Cisplatin (or Carboplatin)
Specified dose on specified days
Intervention: Pemetrexed
Pemetrexed and Cisplatin (or Carboplatin)
Specified dose on specified days
Intervention: Cisplatin
Pemetrexed and Cisplatin (or Carboplatin)
Specified dose on specified days
Intervention: Carboplatin
Outcomes
Primary Outcomes
Overall Survival (OS)
Time Frame: From randomization to the date of death (Up to 40 Months)
Overall Survival was defined as the time from randomization to the date of death due to any cause. A participant who has not died was censored at last known date alive.
Secondary Outcomes
- Objective Response Rate (ORR) According to PD-L1 Expression Level(From randomization date to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (Up to 76 months))
- Disease Control Rate (DCR)(From randomization date to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (Up to 76 months)
- Progression Free Survival (PFS)(From randomization date to the date of first documented tumor progression or death due to any cause, whichever occurs first. (up to 76 months))
- Overall Survival (OS) According to PD-L1 Expression Level(From randomization date to the date of death (Up to 76 Months))
- Progression Free Survival (PFS) According to PD-L1 Expression Level(From randomization date to the date of first documented tumor progression or death due to any cause, whichever occurs first. (up to 76 months))
- Objective Response Rate (ORR)(From randomization date to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (Up to 76 months))
Study Sites (107)
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