MAPS2
Nivolumab or nivolumab plus ipilimumab in patients with relapsed malignant pleural mesothelioma (IFCT-1501 MAPS2): a multicentre, open-label, randomised, non-comparative, phase 2 trial
Phase 2N = 125NCT02716272
- Population
- Adults with histologically proven malignant pleural mesothelioma progressing after first-line or second-line pemetrexed and platinum-based treatment; ECOG performance status 0-1; measurable disease by CT; life expectancy greater than 12 weeks.
- Design
- Multicentre, open-label, randomised (1:1), non-comparative phase 2 trial at 21 hospitals in France: nivolumab 3 mg/kg every 2 weeks, or nivolumab 3 mg/kg every 2 weeks plus ipilimumab 1 mg/kg every 6 weeks, until progression or unacceptable toxicity. Central randomisation stratified by histology, treatment line and chemosensitivity. The two arms were not compared with each other. Primary outcome: proportion with 12-week disease control by masked independent central review, assessed in the first 108 eligible patients; the primary endpoint would be met if disease control was achieved in at least 40% of patients. Efficacy was also analysed in the ITT population. Recruitment 24 March to 25 August 2016.
- Primary endpoint
- 12-week disease control rate
- Arms
- Nivolumab (experimental, n = 63): Nivolumab 3 mg/kg every 2 weeks
- Nivolumab plus ipilimumab (experimental, n = 62): Nivolumab 3 mg/kg every 2 weeks plus ipilimumab 1 mg/kg every 6 weeks
- People
- Scherpereel A
Show the numbers
| Endpoint | Analysis | Nivolumab / Nivolumab plus ipilimumab | Control | Effect |
|---|---|---|---|---|
| 12-week disease control rateFirst 108 eligible patients (54 per arm)Proportion with disease control at 12 weeks by masked independent central review, in the first 108 eligible patients (54 per arm) | primaryScherpereel 2019 | 44% (31–58%) | — | 24 of 54 patients with nivolumab and 27 of 54 with nivolumab plus ipilimumab. The arms are not compared statistically in this non-comparative design. |
| 12-week disease control rateProportion with disease control at 12 weeks, intention-to-treat population | primaryScherpereel 2019 | 40% (28–52%) | — | 25 of 63 patients with nivolumab and 32 of 62 with nivolumab plus ipilimumab. Grade 3-4 toxicities: 9 of 63 (14%) with nivolumab and 16 of 61 (26%) with the combination; toxicities leading to death: none with nivolumab and three (5%) of 62 with the combination. The abstract reports no survival result. |
| Endpoint | Analysis | Nivolumab / Nivolumab plus ipilimumab | Control | Effect |
|---|---|---|---|---|
| 12-week disease control rateFirst 108 eligible patients (54 per arm)Proportion with disease control at 12 weeks by masked independent central review, in the first 108 eligible patients (54 per arm) | primaryScherpereel 2019 | 44% (31–58%) | — | 24 of 54 patients with nivolumab and 27 of 54 with nivolumab plus ipilimumab. The arms are not compared statistically in this non-comparative design. |
| 12-week disease control rateProportion with disease control at 12 weeks, intention-to-treat population | primaryScherpereel 2019 | 40% (28–52%) | — | 25 of 63 patients with nivolumab and 32 of 62 with nivolumab plus ipilimumab. Grade 3-4 toxicities: 9 of 63 (14%) with nivolumab and 16 of 61 (26%) with the combination; toxicities leading to death: none with nivolumab and three (5%) of 62 with the combination. The abstract reports no survival result. |
Appears in
Sources
Scherpereel A, Mazieres J, Greillier L, Lantuejoul S, Dô P, Bylicki O, et al. Nivolumab or nivolumab plus ipilimumab in patients with relapsed malignant pleural mesothelioma (IFCT-1501 MAPS2): a multicentre, open-label, randomised, non-comparative, phase 2 trial. Lancet Oncol. 2019;20(2):239-253.