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Table 2 Efficacy summary.

From: A prospective phase II trial exploring the association between tumor microenvironment biomarkers and clinical activity of ipilimumab in advanced melanoma

Efficacy Measure Ipilimumab 3 mg/kg (n = 40)* Ipilimumab 10 mg/kg (n = 42)*
Response, n (%)   
CR 0 1 (2.4)
PR 3 (7.5) 4 (9.5)
SD 10 (25.0) 3 (7.1)
PD 19 (47.5) 24 (57.1)
Unknown 8 (20.0) 10 (23.8)
BORR, % (95% CI) 7.5 (1.6, 20.4) 11.9 (4.0, 25.6)
DCR, % 32.5 19.0
OS, median, in months 12.9 11.8
1-year survival rate, % (95% CI) 60.9 (41.7, 74.9) 44.2 (24.1, 64.1)
PFS, median (95% CI), in months 2.63 (2.56, 3.88) 2.56 (2.50, 2.66)
Progressed or died, n (%) 28 (70.0) 32 (76.2)
Time to response, median (min- max), in months 2.5 (2.1-5.3) 2.6 (2.6-3.6)
  1. *Four patients (10.0%) in the 3 mg/kg group and five (11.9%) in the 10 mg/kg group were censored from the analyses of response-based endpoints (BORR, PFS, DCR, time to response) because of excision or resection of index lesions.
  2. Estimated.
  3. BORR: best overall response rate; CI: confidence interval; CR: complete response; DCR: disease control rate; OS: overall survival; PD: progressive disease; PFS: progression-free survival; PR: partial response; SD: stable disease.