Table 1.
Patient Demographics
| Patients With Previous IL-2
|
Patients With Enterocolitis
|
|||||||
|---|---|---|---|---|---|---|---|---|
| Diagnosis and Protocol | No. of Patients | Mean Age (years) | Sex Ratio (female:male) | No. | % | Patients Given Vaccine | No. | % |
| Melanoma | 137 | 49 | 45:92 | 67 | 49 | 24 | 18 | |
| Ipilimumab+vaccines | 56 | 51 | 19:37 | 21 | 38 | 56 | 8 | 14 |
| Cohort I 3 mg/kg→1 mg/kg | 27 | 53 | 10:17 | 6 | 29 | 27 | 4 | 15 |
| Cohort II 3 mg/kg→3 mg/kg | 29 | 49 | 9:20 | 15 | 52 | 29 | 4 | 14 |
| Ipilimumab dose escalation | 81 | 48 | 26:55 | 46 | 57 | 16 | 16 | 20 |
| Cohort I 3 mg/kg→9 mg/kg | 38 | 48 | 10:28 | 26 | 68 | 6 | 5 | 13 |
| Cohort II 5 mg/kg→9 mg/kg | 43 | 48 | 16:27 | 20 | 47 | 10 | 11 | 26 |
|
| ||||||||
| Renal cell carcinoma | ||||||||
| Ipilimumab renal cell carcinoma | 61 | 54 | 16:45 | 41 | 67 | 0 | 17 | 28 |
| Cohort I 3 mg/kg→1 mg/kg | 21 | 56 | 4:17 | 21 | 100 | 0 | 3 | 14 |
| Cohort II 3 mg/kg→3 mg/kg | 40 | 53 | 12:28 | 20 | 50 | 0 | 14 | 35 |
NOTE. Ipilimumab is formerly MDX-010.
Abbreviation: IL-2, interleukin-2.