Table 1.
Demographic and Clinical Characteristics of the Patients at Baseline (Intention-to-Treat Population).*
| Characteristic | Nivolumab plus Cabozantinib (N = 323) | Sunitinib (N = 328) |
|---|---|---|
| Age | ||
| Median (range) — yr | 62 (29–90) | 61 (28–86) |
| <65 yr — no. (%) | 191 (59.1) | 210 (64.0) |
| ≥65 yr — no. (%) | 132 (40.9) | 118 (36.0) |
| Sex — no. (%) | ||
| Male | 249 (77.1) | 232 (70.7) |
| Female | 74 (22.9) | 96 (29.3) |
| Geographic region — no. (%) | ||
| United States or Europe | 158 (48.9) | 161 (49.1) |
| Rest of the world | 165 (51.1) | 167 (50.9) |
| Karnofsky performance-status score — no. (%)† | ||
| 90 or 100 | 257 (79.6) | 241 (73.5) |
| 70 or 80 | 66 (20.4) | 85 (25.9) |
| Not reported | 0 | 2 (0.6) |
| IMDC prognostic risk score — no. (%) | ||
| Favorable: 0 | 74 (22.9) | 72 (22.0) |
| Intermediate: 1 or 2 | 188 (58.2) | 188 (57.3) |
| Poor: 3–6 | 61 (18.9) | 68 (20.7) |
| Tumor PD-L1 expression — no. (%) | ||
| ≥1% | 83 (25.7) | 83 (25.3) |
| <1% or indeterminate | 240 (74.3) | 245 (74.7) |
| Sarcomatoid features — no./total no. (%)‡ | ||
| Yes | 34/313 (10.9) | 41/319 (12.9) |
| No | 279/313 (89.1) | 278/319 (87.1) |
| Previous radiotherapy — no. (%) | 46 (14.2) | 45 (13.7) |
| Previous nephrectomy — no. (%) | 222 (68.7) | 233 (71.0) |
| No. of sites with target or nontarget lesions — no. (%)§ | ||
| 1 | 63 (19.5) | 69 (21.0) |
| ≥2 | 259 (80.2) | 256 (78.0) |
| Most common sites of metastasis — no. (%) | ||
| Lung | 238 (73.7) | 249 (75.9) |
| Lymph node | 130 (40.2) | 131 (39.9) |
| Bone | 78 (24.1) | 72 (22.0) |
| Liver | 73 (22.6) | 53 (16.2) |
| Adrenal gland | 36 (11.1) | 36 (11.0) |
The intention-to-treat population includes all the patients who underwent randomization. The International Metastatic Renal-Cell Carcinoma Database Consortium (IMDC) prognostic risk score, programmed death ligand 1 (PD-L1) status, and geographic region (stratification factors) were recorded at screening by means of interactive response technology.
Karnofsky performance-status scores range from 0 to 100, with lower scores indicating greater disability.
Sarcomatoid status was not reported in 10 patients in the nivolumab-plus-cabozantinib group and in 9 patients in the sunitinib group.
Data are for tumor sites defined at baseline by the investigators according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. The number of target or nontarget lesions at baseline was not reported for one patient in the nivolumab-plus-cabozantinib group and for three patients in the sunitinib group.