Table 3 Clinical trials with immunotherapy in patients with melanoma and brain metastasis
From: Progress in personalized immunotherapy for patients with brain metastasis
Author | Study type | Treatment | Patients with brain metastasis | Outcomes |
|---|---|---|---|---|
Margolin et al.129 NCT00623766 | Phase II | Ipilimumab | Cohort A: (neurologically | IDCR: 25% |
asymptomatic) 51 | mOS: 7.0 m | |||
mPFS: 2.7 m | ||||
Intracranial mPFS: 1.9 m | ||||
IDCR: 10% | ||||
Cohort B: (symptomatic and on a stable dose of corticosteroids) 21 | mOS: 3.7 m | |||
mPFS: 1.3 m | ||||
Intracranial mPFS: 1.2 m | ||||
Di Giacomo et al.130 NCT01654692 | Phase II | Ipilimumab + | 20 | IDCR: 50.0% |
Fotemustine | mOS: 13.4 m | |||
mPFS: 4.5 m | ||||
Goldberg et al.131 | Phase II | Pembrolizumab | ||
Kluger et al.132 NCT020850170 | Phase II | Pembrolizumab | 23 | IRR: 26% |
mOS: 17 m | ||||
mPFS: 2 m | ||||
Long et al.133 NCT02374242 | Phase II | Nivolumab + Ipilimumab, followed by Nivolumab | Cohort A: 35 | IRR: 46% |
mOS: NR | ||||
mPFS: 13.8 m | ||||
Intracranial mPFS: NR | ||||
Nivolumab | Cohort B: 25 | IRR: 20% | ||
mOS: 13.8 m | ||||
mPFS: 2.6 m | ||||
Intracranial mPFS: 2.6 m | ||||
Nivolumab | Cohort C: Patients neurologically | IRR: 6% | ||
symptomatic 16 | mOS: 5.1 m | |||
mPFS: 2.6 m | ||||
Intracranial mPFS: 2.3 m | ||||
Tawbi et al.34 NCT02320058 | Phase II | Nivolumab + Ipilimumab, followed by | 94 | IDCR: 57% |
1-year OS rate: 81.5% | ||||
1-year PFS rate: 56.6% | ||||
Tawbi et al.34 NCT03470922 | Phase II | Relatlimab + Nivolumab versus Nivolumab in participants with previously untreated metastatic or unresectable melanoma | Relatlimab + Nivolumab: 355 | ImPFS: 10.1 m (95%[CI], 6.4 to 15.7) with Relatlimab-Nivolumab vs. 4.6 m (95% CI, 3.4 to 5.6) with Nivolumab (HR for progression or death, 0.75 [95% CI, 0.62 to 0.92]; P = 0.006 by the log-rank test |
Nivolumab: 359 | ||||
1-yr PFS rate: 47.7% (95% CI, 41.8 to 53.2) with Relatlimab-Nivolumab vs. 36.0% (95% CI, 30.5 to 41.6) |
