Phase 3
Completed N=605
Study of Nivolumab Combined With Ipilimumab Versus Pemetrexed and Cisplatin or Carboplatin as First Line Therapy in Unresectable Pleural Mesothelioma Patients
Source: ClinicalTrials.gov NCT02899299 ↗Enrolled (actual)
605
Serious AEs
50.3%
Results posted
Apr 2021
Primary outcomePrimary: Overall Survival (OS) — 18.07; 14.09 Months — p=0.0020
◆ Published Evidence
Highly cited
1,194citations · ~239 / year
First-line nivolumab plus ipilimumab in unresectable malignant pleural mesothelioma (CheckMate 743): a multicentre, randomised, open-label, phase 3 trial.
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.
Linked Publications (5)
-
First-line nivolumab plus ipilimumab in unresectable malignant pleural mesothelioma (CheckMate 743): a multicentre, randomised, open-label, phase 3 trial.
-
First-line nivolumab plus ipilimumab versus chemotherapy in patients with unresectable malignant pleural mesothelioma: 3-year outcomes from CheckMate 743.
-
First-line nivolumab plus ipilimumab versus chemotherapy for the treatment of unresectable malignant pleural mesothelioma: patient-reported outcomes in CheckMate 743.
-
FDA Approves Nivolumab Plus Ipilimumab for Previously Untreated Unresectable Malignant Pleural Mesothelioma.
-
Five-Year Clinical Outcomes With Nivolumab Plus Ipilimumab Versus Chemotherapy as First-Line Treatment for Unresectable Pleural Mesothelioma in CheckMate 743.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.