Table 1.
Patient baseline characteristics.
| Cohort A (N = 3) | Cohort B (N = 12) | Overall (N = 15) | |
|---|---|---|---|
| Age in years | |||
| Median (range) | 59 (50–73) | 69 (53–86) | 66 (50–86) |
| Sex | |||
| Male (%) | 3 (100%) | 9 (75.0%) | 12 (80.0%) |
| Female (%) | 0 (0.0%) | 3 (25.0%) | 3 (20.0%) |
| Ethnicity | |||
| White (%) | 3 (100%) | 11 (92%) | 14 (93%) |
| Other (%) | 1 (8%) | 1 (7%) | |
| ECOG performance status | |||
| Score of 0 (%) | 3 (100%) | 8 (67.7%) | 11 (73.3%) |
| Score of 1 (%) | 0 (0.0%) | 4 (33.3%) | 4 (26.7%) |
| Pathologic stage at enrollment per AJCC 8th edition (43) | |||
| IIIA (%) | 1 (33.3%) | 0 (0.0%) | 1 (6.7%) |
| IIIB (%) | 2 (66.7%) | 1 (8.3%) | 3 (20.0%) |
| IV (%) | 0 (0.0%) | 11 (91.7%) | 11 (73.3%) |
| Prior therapies | |||
| Surgery (%) | 1 (33.3%) | 12 (100%) | 13 (86.7%) |
| Radiation (%) | 1 (33.3%) | 9 (75.0%) | 10 (66.7%) |
| Systemic therapy (%) | 0 (0.0%) | 6 (50.0%) | 6 (40.0%) |
| Chemotherapy | 5 | 5 | |
| Immunotherapya | 6 | 6 | |
| Targeted therapy | 1 | 1 | |
| MCPyV statusb | |||
| Positive (%) | 3 (100%) | 9 (75.0%) | 12 (80.0%) |
| Negative (%) | 0 (0.0%) | 3 (25.0%) | 3 (20.0%) |
a
Prior immunotherapies included IFNβ, 4-1BB agonistic antibody, and a Toll-like receptor agonist; none had received prior PD-1 blockade.
b
Viral status was determined by MCPyV oncoprotein serologic status and CM2B4 IHC staining.