Table 1.
Identifier/trial | Agents | Phase | Patient number/cohorts | Outcomes |
---|---|---|---|---|
Melanoma | ||||
NCT01449279/ CA184-04569 | Ipilimumab | Pilot study | N = 185 | 1-year OS rate in patients with stable BM=31% |
NCT0062376670 | Ipilimumab | 2 |
N = 72 Cohort A = 51 patients (asymptomatic, not receiving steroids) Cohort B = 21patients (symptomatic, receiving steroids) |
Cohort A IRR = 24% CohortBIRR = 10% |
NCT01654692/ NIBIT-M171 | Ipilimumab, fotemustine |
2 | N = 20 | IRR = 50% |
NCT023742472 | Ipilimumab, nivolumab | 2 |
N = 79 Cohort A = 36 patients (asymptomatic and untreated ipilimumab/nivolumab) Cohort B = 27 patients (asymptomatic and untreated, nivolumab) Cohort C = 16 patients (symptomatic and treated, nivolumab) |
Cohort A IRR= 46% Cohort B IRR= 20% Cohort C IRR= 6% |
NCT02320058/CheckMate 20411 | Nivolumab, ipilimumab | 2 | N = 94 | IRR = 57% |
NCT0208507073 | Pembrolizumab | 2 | N = 23 | IRR=26% |
Non–small cell lung cancer | ||||
NCT01454102/Checkmate 012 (Arm M)74 | Nivolumab, ipilimumab | 1 | N = 12 | IRR = 16.7% |
NCT01721759 CheckMate 063CheckMate 017 CheckMate 05775 | Nivolumab | Pooled analysis 2 3 3 |
N = 46 | IRR =33% (stable disease) |
NCT02008227/OAK study subgroup76 | Atezolizumab, docetaxel | I3 | N = 61 | Atezolizumab with greater reduction in new BM, vs docetaxel |
NCT0208507077 | Pembrolizumab | 2 |
N = 39 Cohort A = 34 (PD-L1 positive) Cohort B = 5 (PD-L1 negative) |
Cohort A IRR = 29% Cohort B IRR = 0% |
Nivolumab expanded access program78 | Nivolumab | Pilot study | N = 409 | ORR = 17% DCR =39% in CNS metastasis patients (overall response, no CNS disease) |
Multiple tumor types | ||||
NCT0208507079 | Pembrolizumab | 2 |
N = 36 (18 with melanoma18 with NSCLC) |
IRR melanoma = 22% IRR NSCLC = 33% |
Abbreviations: BM, brain metastases; CNS, central nervous system; DCR, disease control rate (complete response = partial response + stable disease); IRR, intracranial response rate; NSCLC, non–small cell lung cancer; ORR, overall response rate; OS, overall survival.