Clinical activity of ipilimumab and ipilimumab plus nivolumab
| Ipilimumab (N=9) | Ipilimumab plus nivolumab (N=10) | Total (N=19) | |
| Best response at week 18, n (%) | |||
| Complete response | 1 (11) | 0 | 1 (5) |
| PR | 4 (44) | 2 (20) | 6 (32) |
| Stable disease | 1 (11) | 4 (40) | 5 (26) |
| Progressive disease | 3 (33) | 3 (30) | 6 (32) |
| Could not be evaluated* | 0 | 1 (10) | 1 (5) |
| Objective response rate at week 18 | |||
| n (%) | 5 (56) | 2 (20) | 7 (37) |
| 95% CI | 21 to 86 | 3 to 56 | 16 to 62 |
| Disease control rate at week 18 | |||
| n (%) | 6 (67) | 6 (60) | 12 (63) |
| 95% CI | 30 to 93 | 26 to 88 | 38 to 84 |
| CB rate† | |||
| n (%) | 6 (67) | 5 (50) | 11 (58) |
| 95% CI | 30 to 93 | 19 to 81 | 34 to 80 |
| Time to treatment failure (months) | |||
| Median | 13.6 | 26.9 | 13.6 |
| 95% CI | 2.8 to NE | 0.7 to NE | 6.7 to NE |
| Overall survival (months) | |||
| Median | NE | NE | NE |
| 95% CI | 11.5 to NE | 1.6 to NE | 13.5 to NE |
The best overall response was assessed by the investigator with the use of the Response Evaluation Criteria in Solid Tumors V.1.1. Patients are grouped according to the treatment assigned at randomization. Two patients had treatment different from the one assigned at randomization. The patient randomized to the ipilimumab arm who received ipilimumab plus nivolumab had a best overall response of PR. The patient randomized to the ipilimumab plus nivolumab arm who received ipilimumab monotherapy had a best overall response of PR.
*One patient in the ipilimumab plus nivolumab arm died due to clinical progression prior to the first scheduled on-treatment tumor assessment.
†CB is defined as a complete or PR at any time or a best response of stable disease with no evidence of radiographic progression within 6 months.
CB, clinical benefit; NE, not estimable; PR, partial response.