|
| Study reference | No. of patients eligible for analysis (followup) | Study design | Primary endpoint | Dose and schedule—treatment arm | ORR/OS | PFS (mths) | HR (95% CI) |
|
| BMS 008 [100] | 155 | Phase II, open-label, single arm | Dose finding | Ipilimumab—10 mg/kg | 47% (1 yr) | N/A | N/A |
|
| BMS 022 [101] | 217 | Phase II, randomized, double blind | To evaluate the efficacy of three dose levels of ipilimumab | Ipilimumab—10 mg/kg | 48% (1 yr) | N/A | N/A |
|
| BMS 007 [102] | 115 | Phase II, randomized, double blind | To evaluate the rate of grade 2 + diarrhea | Ipilimumab—10 mg/kg | 51% (1 yr) | N/A | N/A |
|
| Medarex MDX010-20 [3] | 676 | Phase III, randomized, double blind | ORR, subsequently amended to OS | Ipilimumab—3 mg/kg | Ipi alone: 10.1 mths (95% CI 8.0 to 13.8)
Ipi + GP-100: 10.0 mths (95% CI 8.5 to 11.5)
GP-100 alone: 6.4 mths (95% CI 5.5 to 8.7) | Ipi alone: 2.86 mths (95% CI 2.76 to 3.02)
Ipi + GP-100: 2.76 mths (95% CI 2.73 to 2.79)
GP-100 alone: 2.76 mths (95% CI 2.73 to 2.83) | Ipi alone (compared to GP-100 alone):0.66 (95% CI 0.51-0.87)
Ipi + GP-100 (compared to GP-100 alone):0.68 (95% CI 0.55-0.85) |
|
| BMS 024 [103] | 502 | Phase III, randomized, double blind | OS | Ipilimumab + DTIC: Induction—IPI 10 mg/kg + DTIC (850 mg/m2) q3 weeks for 4 doses Maintenance—IPI 10 mg/kg + DTIC (850 mg/m2) q12 weeks | Ipi + DTIC: 47.3% (1 yr), 28.5% (2 yr), 20.8% (3 yr)
DTIC alone: 36.3% (1 yr), 17.9% (2 yr), 12.2% (3 yr) | Ipi + DTIC: 2.8
DTIC alone: 2.6 | Ipi + DTIC:
OS 0.72
PFS 0.76 |
|
| BRIM 2 [104] | 132 | Phase II, open label | BORR | Vemurafenib (PLX-4032) 960 mg twice daily orally | BORR: 52.3%
CR: 2.3%
PR: 50% | 6.2 | N/A |
|
| BRIM 3 [5] | 675 | Phase III, randomized, double blind | OS | Vemurafenib (PLX-4032) 960 mg twice daily orally | PLX-4032: 84% (6 mos)
DTIC alone: 64% (6 mos) | PLX-4032: 5.3
DTIC alone: 1.6 | Death 0.37 (95% CI 0.26 to 0.55)
Progression 0.26 (95% CI 0.20 to 0.33) |
|
