Table 1:
Baseline Patient Demographic and Clinical Characteristics
Nivolumab dose de-escalation cohort (N=13) |
Nivolumab Solid Tumor Expansion (N=23) |
Overall (N=36) |
|
---|---|---|---|
Sex | |||
Male | 12 (92.3%) | 21 (91.3%) | 33 (91.7%) |
Female | 1 (7.7%) | 2 (8.7%) | 3 (8.3%) |
Age | |||
Median [Q1-Q3] | 56.8 [53.7–59.4] | 51.6 [40.6–58.9] | 54.6 [47.5–59.3] |
Race and Ethnicity | |||
American Indian or Alaska Native | 1 (7.7%) | 0 (0%) | 1 (2.8%) |
Hispanic White | 0 (0%) | 3 (13.0%) | 3 (8.3%) |
Non-Hispanic Black | 4 (30.8%) | 6 (26.1%) | 10 (27.8%) |
Non-Hispanic White | 8 (61.5%) | 13 (56.5%) | 21 (58.3%) |
Other/Unknown | 0 (0%) | 1 (4.3%) | 1 (2.8%) |
Baseline CD4 count | |||
>=200 | 5 (38.5%) | 23 (100%) | 28 (77.8%) |
100–199 | 8 (61.5%) | 0 (0%) | 8 (22.2%) |
Prior treatments received | |||
0 | 0 (0%) | 1 (4.3%) | 1 (2.8%) |
1 | 13 (100%) | 20 (87.0%) | 33 (91.7%) |
2 | 0 (0%) | 2 (8.7%) | 2 (5.6%) |
ECOG performance status | |||
0 | 4 (30.8%) | 11 (47.8%) | 15 (41.7%) |
1 | 9 (69.2%) | 12 (52.2%) | 21 (58.3%) |
Tumor histology | |||
Anal cancer | 4 (30.8%) | 0 (0%) | 4 (11.1%) |
Head & neck squamous cell carcinoma | 2 (15.4%) | 0 (0%) | 2 (5.6%) |
Kaposi’s Sarcoma | 0 (0%) | 15 (65.2%) | 15 (41.7%) |
Liver cancer | 0 (0%) | 1 (4.3%) | 1 (2.8%) |
Non-small cell lung cancer | 1 (7.7%) | 1 (4.3%) | 2 (5.6%) |
Others* | 6 (46.2%) | 6 (26.1%) | 12 (33.3%) |
Pancreatic cancer, skin squamous cell cancer, breast cancer, gallbladder cancer, follicular dendritic sarcoma, small cell lung cancer, colon cancer, squamous cell cancer of unknown primary, liposarcoma, and ovarian cancer