Table 1.
Baseline Characteristics of the Patients.*
| Characteristic | Progression-free Survival Population | Intention-to-Treat Population | ||
|---|---|---|---|---|
| Experimental (N = 276) | Control (N = 274) | Experimental (N = 428) | Control (N = 427) | |
| Median age (range) — yr | 61 (29–82) | 60 (28–85) | 61(19–85) | 60 (28–87) |
| Sex — no. (%) | ||||
| Male | 213 (77) | 204 (74) | 326 (76) | 312 (73) |
| Female | 63 (23) | 70 (26) | 102 (24) | 115 (27) |
| Geographic region — no. (%) | ||||
| United States, Canada, Europe, Australia, or New Zealand | 195 (71) | 192 (70) | 278 (65) | 278 (65) |
| Latin America or Asia | 81 (29) | 82 (30) | 150 (35) | 149 (35) |
| Race or ethnic group — no. (%)† | ||||
| Asian | 19 (7) | 26 (9) | 29 (7) | 33 (8) |
| Black | 1 (<1) | 5 (2) | 3 (1) | 6 (1) |
| Native American or Alaska Native | 2 (1) | 6 (2) | 4 (1) | 10 (2) |
| White | 224 (81) | 207 (76) | 339 (79) | 331 (78) |
| Multiple | 1 (<1) | 1 (<1) | 2 (<1) | 2 (<1) |
| Other | 10 (4) | 9 (3) | 22 (5) | 20 (5) |
| Not reported | 19 (7) | 20 (7) | 29 (7) | 25 (6) |
| IMDC risk category — no. (%)‡ | ||||
| Intermediate | 209 (76) | 208 (76) | 321 (75) | 321 (75) |
| Poor | 67 (24) | 66 (24) | 107 (25) | 106 (25) |
| Karnofsky performance-status score — no. (%)§ | ||||
| 90 or 100 | 162 (59) | 178 (65) | 251 (59) | 269 (63) |
| 70 or 80 | 113 (41) | 95 (35) | 174 (41) | 157 (37) |
| <70 | 0 | 0 | 1 (<1) | 0 |
| Missing data | 1 (<1) | 1 (<1) | 2 (<1) | 1 (<1) |
| PD-L1 tumor proportion score — no. (%)¶ | ||||
| <1% | 182 (66) | 168 (61) | 272 (64) | 264 (62) |
| ≥1% | 50 (18) | 62 (23) | 84 (20) | 94 (22) |
| Could not be determined or data were missing | 44 (16) | 44 (16) | 72 (17) | 69 (16) |
| Previous nephrectomy — no. (%) | 177 (64) | 176 (64) | 278 (65) | 276 (65) |
| No. of organs with target and nontarget lesions — no. (%)|| | ||||
| 1 | 73 (26) | 78 (28) | 116 (27) | 114 (27) |
| >2 | 201 (73) | 194 (71) | 308 (72) | 309 (72) |
| Missing data | 2 (1) | 2 (1) | 4 (1) | 4 (1) |
| Median sum of diameters of target lesions (range) — mm|| | 87.4 (11.5–468.5) | 84.8 (10.8–392.4) | 94.7 (10.1–468.5) | 89.7 (10.8–392.4) |
| Most common sites of target and nontarget lesions — no. (%)|| | ||||
| Lung | 180 (65) | 186 (68) | 277 (65) | 282 (66) |
| Lymph node | 130 (47) | 119 (43) | 203 (47) | 185 (43) |
| Kidney** | 109 (39) | 100 (36) | 168 (39) | 155 (36) |
| Liver | 47 (17) | 39 (14) | 74 (17) | 66 (15) |
| Bone | 33 (12) | 57 (21) | 54 (13) | 83 (19) |
| Adrenal | 33 (12) | 40 (15) | 57 (13) | 55 (13) |
Patients were assigned to receive cabozantinib in addition to nivolumab and ipilimumab (experimental group) or placebo in addition to nivolumab and ipilimumab (control group). The progression-free survival population included the first 550 patients who had undergone randomization, and the intention-to-treat population included all the patients who had undergone randomization. Percentages may not total 100 because of rounding.
Race or ethnic group was reported by the patients.
The International Metastatic Renal-Cell Carcinoma Database Consortium (IMDC) risk category was determined with the use of the IxRS interactive voice- and Web-based response system.
Karnofsky performance-status scores range from 0 to 100, with lower scores reflecting greater disability.
The programmed death ligand 1 (PD-L1) tumor proportion score is the percentage of viable tumor cells that show PD-L1 membrane stain ing of any intensity.
The data were determined by an independent radiology committee whose members were unaware of trial-group assignments.
Target and nontarget lesions could include the primary tumor.