Table 1.
Patient characteristics
| Phase Ib (N = 6) | Phase II, cohort 1 (N = 36) | Phase II, cohort 2 (N = 15) | |
|---|---|---|---|
| Sex | |||
| Female | 1 (17%) | 11 (31%) | 4 (27%) |
| Male | 5 (83%) | 25 (69%) | 11 (73%) |
| Age, median (range) | 63 (50–72) | 68 (40–85) | 65 (46–93) |
| Race | |||
| White | 5 (83%) | 33 (92%) | 15 (100%) |
| Black or African American | 1 (16.7%) | 1 (2.8%) | 0 (0%) |
| Asian | 0 (0%) | 1 (2.8%) | 0 (0%) |
| Unknown | 0 (0%) | 1 (2.8%) | 0 (0%) |
| Ethnicity | |||
| Hispanic or Latino | 0 (0%) | 0 (0%) | 1 (6.7%) |
| Non-Hispanic | 6 (100%) | 35 (97%) | 14 (93%) |
| Unknown | 0 (0%) | 1 (2.8%) | 0 (0%) |
| IMDC risk | |||
| Poor | 0 (0%) | 2 (6%) | 2 (13%) |
| Intermediate | 6 (100%) | 34 (94%) | 13 (87%) |
| Favorable | 0 (0%) | 0 (0%) | 0 (0%) |
| Clear cell renal cell carcinoma | |||
| Mixed | 2 (33%) | 7 (19%) | 5 (33%) |
| Pure | 4 (67%) | 29 (81%) | 10 (67%) |
| Sarcomatoid histology | |||
| Yes | 2 (33%) | 6 (17%) | 4 (27%) |
| No | 3 (50%) | 23 (64%) | 9 (60%) |
| NA | 1 (17%) | 7 (19%) | 2 (13%) |
| ECOG performance status | |||
| 0 | 4 (67%) | 20 (56%) | 6 (40%) |
| 1 | 2 (33%) | 16 (44%) | 9 (60%) |
| Any prior therapy | 6 (100%) | 15 (42%) | 15 (100%) |
IMDC International Metastatic RCC Database Consortium