A Phase 1 Study of Nivolumab (BMS-936558) in Subjects With Advanced or Recurrent Malignancies
Phase 1N = 296NCT00730639
- Population
- Advanced solid tumours (melanoma, non-small-cell lung, castration-resistant prostate, renal-cell and colorectal cancer); 296 patients treated through 24 February 2012, of whom 94 with melanoma were evaluable for response
- Design
- Phase 1 dose-escalation study of the anti-PD-1 antibody BMS-936558 (nivolumab) at 0.1 to 10.0 mg per kilogram every 2 weeks for up to 12 cycles in advanced melanoma, non-small-cell lung cancer, castration-resistant prostate cancer, renal-cell and colorectal cancer; response assessed after each 8-week cycle. The registry record (MDX1106-03) lists 395 enrolled; the paper treated 296 through 24 February 2012.
- Arms
- Anti-PD-1 antibody (BMS-936558) (experimental): Anti-PD-1 antibody 0.1 to 10.0 mg per kilogram of body weight every 2 weeks, up to 12 cycles
- People
- Topalian SL, senior author Sznol M
Show the numbers
| Endpoint | Analysis | Anti-PD-1 antibody (BMS-936558) | Control | Effect |
|---|---|---|---|---|
| ORRMelanoma patients in whom response could be evaluated (94) | primaryTopalian 2012 | 28% | — | Cumulative objective response rate across all doses: 26 of 94 melanoma patients. Of 31 responders with at least 1 year of follow-up, 20 responses lasted 1 year or more (all tumour types combined). Grade 3 or 4 drug-related adverse events occurred in 14% of all treated patients. |
| Endpoint | Analysis | Anti-PD-1 antibody (BMS-936558) | Control | Effect |
|---|---|---|---|---|
| ORRMelanoma patients in whom response could be evaluated (94) | primaryTopalian 2012 | 28% | — | Cumulative objective response rate across all doses: 26 of 94 melanoma patients. Of 31 responders with at least 1 year of follow-up, 20 responses lasted 1 year or more (all tumour types combined). Grade 3 or 4 drug-related adverse events occurred in 14% of all treated patients. |