Phase 3
N=605
Study of Nivolumab Combined With Ipilimumab Versus Pemetrexed and Cisplatin or Carboplatin as First Line Therapy in Unresectable Pleural Mesothelioma Patients
Mesothelioma
Bottom Line
View on ClinicalTrials.gov: NCT02899299 ↗Enrolled (actual)
605
Serious AEs
50.3%
Results posted
Apr 2021
Primary outcome: Primary: Overall Survival (OS) — 18.07; 14.09 Months — p=0.0020
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Nivolumab (Biological); Ipilimumab (Biological); Pemetrexed (Drug); Cisplatin (Drug); Carboplatin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival (OS) |
18.07; 14.09 | 0.0020 sig |
| SECONDARY Objective Response Rate (ORR) |
39.3; 44.4 | — |
| SECONDARY Disease Control Rate (DCR) |
76.6; 85.8 | — |
| SECONDARY Progression Free Survival (PFS) |
6.77; 7.23 | — |
| SECONDARY Overall Survival (OS) According to PD-L1 Expression Level |
17.3; 16.6; 18.0; 13.3 | — |
| SECONDARY Progression Free Survival (PFS) According to PD-L1 Expression Level |
4.1; 8.3; 7.0; 7.1 | — |
| SECONDARY Objective Response Rate (ORR) According to PD-L1 Expression Level |
21.1; 41.0; 43.1; 45.7 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02899299). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.