CONFIRM (malignant pleural mesothelioma)
Trial question
What is the role of nivolumab in patients with relapsed malignant pleural mesothelioma?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
24.0% female
76.0% male
N = 332
332 patients (79 female, 253 male).
Inclusion criteria: patients with relapsed malignant pleural mesothelioma.
Key exclusion criteria: previous treatment with an immune checkpoint inhibitor; uncontrolled metastasis involving the CNS; autoimmune disease.
Interventions
N=221 nivolumab (at a dose of 240 mg IV administered over 30 minutes every 2 weeks until disease progression or a maximum of 12 months).
N=111 placebo (matching placebo until disease progression or a maximum of 12 months).
Primary outcome
Median progression-free survival
3 months
1.8 months
3.0 months
2.3 months
1.5 months
0.8 months
0.0 months
Nivolumab
Placebo
Significant
increase ▲
Significant increase in median progression-free survival (3 months vs. 1.8 months; HR 1.49, 95% CI 1.18 to 1.89).
Secondary outcomes
Significant increase in median overall survival (10.2 months vs. 6.9 months; HR 1.45, 95% CI 1.1 to 1.92).
Significant increase in partial response rate (11% vs. 1%; OR 14, 95% CI 5.8 to 22.2).
Safety outcomes
No significant difference in serious adverse events.
Conclusion
In patients with relapsed malignant pleural mesothelioma, nivolumab was superior to placebo with respect to median progression-free survival.
Reference
Dean A Fennell, Sean Ewings, Christian Ottensmeier et al. Nivolumab versus placebo in patients with relapsed malignant mesothelioma (CONFIRM): a multicentre, double-blind, randomised, phase 3 trial. Lancet Oncol. 2021 Nov;22(11):1530-1540.
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