Table 1.
Baseline demographic and clinical characteristics in all randomized patients
| Nivolumab (n=18) |
Nivolumab plus ipilimumab (n=21) |
Nivolumab plus ipilimumab plus cobimetinib (n=30) | |
| Age, median (range), years | 66.5 (35‒76) | 63.0 (47‒79) | 65.0 (31‒78) |
| <65 | 5 (28) | 11 (52) | 13 (43) |
| ≥65 | 13 (72) | 10 (48) | 17 (57) |
| Sex, n (%) | |||
| Male | 13 (72) | 11 (52) | 18 (60) |
| Female | 5 (28) | 10 (48) | 12 (40) |
| Race, n (%) | |||
| White | 16 (89) | 19 (90) | 23 (77) |
| Black or African American | 1 (6) | 1 (5) | 4 (13) |
| Asian | 1 (6) | 1 (5) | 1 (3) |
| Other | 0 | 0 | 2 (7) |
| Region, n (%) | |||
| USA | 16 (89) | 16 (76) | 30 (100) |
| Rest of the world | 2 (11) | 5 (24) | 0 |
| Prior lines of therapy, n (%) | |||
| 0 | 0 | 0 | 1 (3) |
| 1 | 9 (50) | 2 (10) | 10 (33) |
| 2 | 3 (17) | 8 (38) | 17 (57) |
| ≥3 | 6 (33) | 11 (52) | 2 (7) |
| Prior systemic regimens in the neoadjuvant setting,* n (%) | |||
| 0 | 15 (83) | 20 (95) | 25 (83) |
| 1 | 1 (6) | 1 (5) | 5 (17) |
| 2 | 2 (11) | 0 | 0 |
| Prior systemic regimens in the adjuvant setting,* n (%) | |||
| 0 | 11 (61) | 16 (76) | 19 (63) |
| 1 | 7 (39) | 5 (24) | 11 (37) |
| Prior systemic regimens in the metastatic setting, n (%) | |||
| 0 | 3 (17) | 0 | 6 (20) |
| 1 | 6 (33) | 3 (14) | 9 (30) |
| 2 | 7 (39) | 6 (29) | 13 (43) |
| ≥3 | 2 (11) | 12 (57) | 2 (7) |
| Prior surgery related to cancer, n (%) | |||
| Yes | 11 (61) | 8 (38) | 10 (33) |
| No | 7 (39) | 13 (62) | 20 (67) |
| ECOG PS, n (%) | |||
| 0 | 12 (67) | 10 (48) | 4 (13) |
| 1 | 6 (33) | 11 (53) | 25 (83) |
| 2 | 0 | 0 | 1 (3) |
| Site of metastases,† n (%) | |||
| Liver | 10 (56) | 16 (76) | 18 (60) |
| Lung | 6 (33) | 9 (43) | 11 (37) |
| Lymph node | 7 (39) | 8 (38) | 12 (40) |
| Median (range) index tumor burden, mm | 68.5 (10–135) | 80.0 (19–237) | 79.0 (15–221) |
| Time from initial diagnosis to study treatment, median (range), years | 1.2 (0.6–4.1) | 1.2 (0.4–2.6) | 1.2 (0.5–5.3) |
| LDH | |||
| ≤ULN | 16 (89) | 17 (81) | 25 (83) |
| >ULN | 2 (11) | 4 (19) | 4 (3) |
| Not reported | 0 | 0 | 1 (3) |
| Neutrophil/lymphocyte ratio, n (%) | |||
| ≤5 | 9 (50) | 15 (71) | 19 (63) |
| >5 | 9 (50) | 6 (29) | 11 (37) |
| ≤8 | 13 (72) | 19 (90) | 25 (83) |
| >8 | 5 (28) | 2 (10) | 5 (17) |
| Albumin | |||
| <LLN | 0 | 3 (14) | 5 (17) |
| ≥LLN | 1 (6) | 9 (43) | 25 (83) |
| Not reported | 17 (94) | 9 (43) | 0 |
*One patient in the nivolumab arm and five patients in the nivolumab plus ipilimumab plus cobinetinib arm received systemic therapies in both neoadjuvant and adjuvant settings.
†Patients could have lesions at more than one site.
ECOG PS, Eastern Cooperative Oncology Group performance status; LDH, lactate dehydrogenase; LLN, lower limit of normal; ULN, upper limit of normal.