Table 3.
Safety
| Ipilimumab dose |
||||||
|---|---|---|---|---|---|---|
| 3 mg/kg |
5 mg/kg | 10 mg/kg |
||||
| −XRT (n = 8; %) | +XRT (n = 7; %) | −XRT (n = 6; %) | −XRT (n = 16; %) | +XRT (n = 34; %) | ±XRT (n = 50; %) | |
| AEs, any gradea | ||||||
| Any treatment-related | 8 (100) | 6 (86) | 5 (83) | 16 (100) | 29 (85) | 45 (90) |
| Any immune-related | 6 (75) | 4 (57) | 5 (83) | 16 (100) | 24 (71) | 40 (80) |
| Diarrhea | 4 | 3 | 3 | 13 (81) | 14 (41) | 27 (54) |
| Rash | 1 | 1 | 2 | 9 (56) | 7 (21) | 16 (32) |
| Colitis | 1 | 1 | 2 | 7 (44) | 4 (12) | 11 (22) |
| Pruritus | 2 | 0 | 1 | 6 (38) | 4 (12) | 10 (20) |
| Fatigue | 6 | 3 | 3 | 8 (50) | 17 (50) | 25 (50) |
| Nausea | 3 | 3 | 2 | 3 (19) | 9 (27) | 12 (24) |
| Decreased appetite | 2 | 3 | 1 | 2 (13) | 9 (27) | 11 (22) |
| Vomiting | 2 | 2 | 0 | 2 (13) | 7 (21) | 9 (18) |
| AEs, grade 3/4b | ||||||
| Any treatment-related | 2 (25) | 3 (43) | 3 (50) | 10 (63) | 13 (38) | 23 (46) |
| Any immune-related | 1 (13) | 3 (43) | 3 (50) | 10 (63) | 6 (18) | 16 (32) |
| Colitis | 1 | 1 | 1 | 6 (38) | 2 (6) | 8 (16) |
| Hepatitis | 0 | 0 | 0 | 3 (19) | 2 (6) | 5 (10) |
| Diarrhea | 0 | 2 | 1 | 2 (13) | 2 (6) | 4 (8) |
| Fatigue | 0 | 1 | 0 | 0 | 3 (9) | 3 (6) |
| Laboratory abnormalities, any gradea,c | ||||||
| Evaluable patients | 8 | 6 | 5 | 15 (100) | 34 (100) | 49 (100) |
| Lymphopenia | 7 | 5 | 3 | 12 (80) | 31 (91) | 43 (88) |
| Hemoglobin decreased | 7 | 6 | 4 | 12 (80) | 28 (82) | 40 (82) |
| Alkaline phosphatase increased | 3 | 5 | 4 | 7 (47) | 21 (62) | 28 (57) |
| Alanine aminotransferase increased | 0 | 2 | 2 | 7 (47) | 10 (29) | 17 (35) |
| Aspartate aminotransferase increased | 0 | 2 | 2 | 6 (40) | 8 (24) | 14 (29) |
| Amylase increased | 2 | 0 | 3 | 4 (27) | 4 (12) | 8 (16) |
| Laboratory abnormalities, grade 3/4b,c | ||||||
| Evaluable patients | 8 | 6 | 5 | 15 (100) | 34 (100) | 49 (100) |
| Hemoglobin decreased | 0 | 0 | 0 | 1 (7) | 6 (18) | 7 (14) |
| Lymphopenia | 0 | 1 | 0 | 2 (13) | 3 (9) | 5 (10) |
| Alkaline phosphatase increased | 0 | 1 | 0 | 1 (7) | 5 (15) | 6 (12) |
| Alanine aminotransferase increased | 0 | 0 | 1 | 2 (13) | 1 (3) | 3 (6) |
| AEs leading to study therapy discontinuation | ||||||
| Any treatment-related AEs | 2 | 3 | 2 | 6 (38) | 8 (24) | 14 (28) |
| Any irAEs | 2 | 3 | 2 | 6 (38) | 5 (15) | 11 (22) |
| Diarrhea/colitis | 2 | 3 | 2 | 3 (19) | 3 (9) | 6 (12) |
| Hepatitis | 0 | 0 | 0 | 3 (19) | 1 (3) | 4 (8) |
| Diarrhea/colitis/hepatitis | 0 | 0 | 0 | 0 | 1 (3) | 1(2) |
| Death | 5 | 3 | 4 | 7 (44) | 18 (53) | 25 (50) |
| Within 30 days after last dose | 0 | 0 | 0 | 0 | 2 (6) | 2 (4) |
aListed were those AEs or laboratory abnormalities that occurred in ≥15% of patients in the 10 mg/kg ± XRT group.
bListed were those AEs or laboratory abnormalities that occurred in ≥5% of patients in the 10 mg/kg ± XRT group. All but three cases of hepatitis in the 10 mg/kg cohort were grade 3.
cCalculated from laboratory values.
XRT, external-beam radiotherapy; AEs, adverse events.