Table 1:
Demographic and clinical characteristics at baseline in the intent-to-treat population
| Characteristic | Nivolumab plus ipilimumab (N=405) |
Placebo (N=411) |
|---|---|---|
| Median age (Q1, Q3) — years | 58 (51, 65) | 57 (50, 65) |
| Age — n (%) | ||
| <65 | 293 (72) | 301 (73) |
| ≥65 | 112 (28) | 110 (27) |
| ≥65 and <75 | 93 (23) | 91 (22) |
| ≥75 and <85 | 19 (5) | 19 (5) |
| Sex — n (%) | ||
| Male | 286 (71) | 294 (72) |
| Female | 119 (29) | 117 (28) |
| Race — n (%) | ||
| White | 302 (75) | 321 (78) |
| Black or African American | 3 (<1) | 6 (1) |
| American Indian or Alaska native | 0 | 3 (<1) |
| Asian | 93 (23) | 65 (16) |
| Native Hawaiian or other Pacific Islander | 0 | 1 (<1) |
| Other | 7 (2) | 13 (3) |
| Not reported | 0 | 2 (<1) |
| Ethnicity — n (%) | ||
| Hispanic or Latino | 41 (10) | 44 (11) |
| Not Hispanic or Latino | 189 (47) | 198 (48) |
| Not reported | 175 (43) | 169 (41) |
| Region — n (%) | ||
| US/Canada/W. Europe/N. Europe | 224 (55) | 240 (58) |
| Rest of the world | 181 (45) | 171 (42) |
| ECOG performance status — n (%) | ||
| 0 | 341 (84) | 361 (88) |
| 1 | 64 (16) | 50 (12) |
| Type of nephrectomy* — n (%) | ||
| Radical | 378 (93) | 381 (93) |
| Partial | 27 (7) | 30 (7) |
| Pathological TNM staging* — n (%) | ||
| pT2a G3 or G4, N0 M0 / pT2b, G any, N0 M0 | 60 (15) | 62 (15) |
| pT3, G any, N0 M0 | 315 (78) | 316 (77) |
| pT4, G any, N0 M0 / pT any, G any, N1 M0 | 30 (7) | 33 (8) |
| Disease risk category — n (%)† | ||
| High risk | 228 (56) | 233 (57) |
| Moderate risk | 176 (43) | 177 (43) |
| Other | 1 (<1) | 1 (<1) |
| Fuhrman grade — n (%) | ||
| Grade 1–2 | 136 (34) | 147 (36) |
| Grade 2 | 126 (31) | 136 (33) |
| Grade 3 | 189 (47) | 173 (42) |
| Grade 4 | 80 (20) | 91 (22) |
| Sarcomatoid features — n (%) | ||
| Yes | 19 (5) | 21 (5) |
| No | 386 (95) | 390 (95) |
| Time from initial disease diagnosis to randomisation — n (%) | ||
| <1 year | 405 (100) | 411 (100) |
| LDH level — n (%) | ||
| ≤1·5 × ULN | 400 (99) | 408 (99) |
| >1·5 × ULN | 0 | 1 (<1) |
| Not reported | 5 (1) | 2 (<1) |
| Haemoglobin — n (%) | ||
| <LLN | 95 (23) | 90 (22) |
| ≥LLN | 310 (77) | 321 (78) |
| Corrected calcium — n (%) | ||
| ≤10 mg/dL | 368 (91) | 377 (92) |
| >10 mg/dL | 27 (7) | 17 (4) |
| Not reported | 10 (2) | 17 (4) |
| Alkaline phosphatase – n (%) | ||
| <ULN | 375 (93) | 373 (91) |
| ≥ULN | 29 (7) | 38 (9) |
| Not reported | 1 (<1) | 0 |
*
Per interactive response technology.
†
Disease-free survival was assessed in the high and moderate risk subgroups by using the following risk staging system: high risk (pT3, G3 or G4, N0 M0; pT4, Gany, N0 M0; pTany, Gany, N1 M0) and moderate risk (pT2a, G3 or G4, N0 M0; pT2b, Gany, N0 M0; PT3, G1 and G2, N0 M0).
ECOG-Eastern Cooperative Oncology Group. LLN=lower limit of normal. Q=quartile. ULN=upper limit of normal.