Table 1:
Baseline demographics
| Treatment group | |||
|---|---|---|---|
| Cohort 1 (N = 3) | Cohort 2 (N = 6) | ||
| Age | |||
| Median (yr) | 76 | 82 | |
| Sex - no. | |||
| Male | 3 | 5 | |
| ECOG performance status score | |||
| 0 | 3 | 6 | |
| Tumor stage - no. | |||
| Tis | 1 | 2 | |
| TaHG | 0 | 2 | |
| TaHG + CIS | 1 | 1 | |
| T1 | 1 | 0 | |
| T1HG | 0 | 1 | |
| PD-L1 status | |||
| Combined positive score ≤ 10 | 2 | 4 | |
| Adverse events attributed to BCG | |||
| Maximum Event Grade | |||
| Grade 1–2 | 3 | 6 | |
| Adverse events attributed to Pembrolizumab | |||
| Maximum Event Grade | |||
| Grade 1–2 | 3 | 4 | |
| Grade 5 | 0 | 1 | |
| Number of doses of BCG | Overall (N = 9) | ||
| Median (range) | 12 (6–27) | ||
| Other BCG unresponsive therapies - no. | |||
| Docetaxel | 3 | ||
| Gemcitabine | 1 | ||
| Nadofaragene Firadenovec | 1 | ||