Table 1.
Demographics and Clinical Characteristics of Patients Consented to Study (n=20)
| Patient Characteristics | Cohort | |
|---|---|---|
|
| ||
| Initial | Expansion | |
| Median age (range) | 65.5 (53–82) | 64 (56–82) |
|
| ||
| Gender | ||
| Male | 11 | 4 |
| Female | 5 | 0 |
|
| ||
| Karnofsky Performance Status | ||
| 70 | 1 | 1 |
| 80 | 7 | 3 |
| 90 | 8 | 0 |
|
| ||
| Bellmunt Criteria Score* | ||
| 0 | 0 | 0 |
| 1 | 10 | 3 |
| 2 | 6 | 1 |
|
| ||
| Number of Previous Therapies | ||
| 1 | 5 | 1 |
| 2 | 5 | 2 |
| 3 | 5 | 0 |
| 4 | 1 | 0 |
| 5 | 0 | 1 |
| Previous Therapies | ||
| Platinum-based | 18 | 3 |
| (Gemcitabine/Cisplatin, Gemcitabine/Carboplatin) | ||
| Taxane | 2 | 1 |
| (Paclitaxel) | ||
| Antimetabolite | 8 | 2 |
| (Pemetrexed) | ||
| Targeted Agent | 4 | 0 |
| (Gemcitabine/Pazopanib, Gemcitabine/Cisplatin/Sunitinib, Gemcitabine/Cisplatin/Bevacizumab or placebo, Docetaxel/Glesatinib) | 0 | 1 |
| Immunotherapy | ||
| (Atezolizumab) | 3 | 2 |
| Other | ||
| (Gemcitabine, Gemcitabine/Docetaxel, Gemcitabine + Radiotherapy) | ||
|
| ||
| Primary Tumor Site | ||
| Bladder | 9 | 4 |
| Upper Tract | 7 | 0 |
| Renal Pelvis | 5 | |
| Ureter | 2 | |
|
| ||
| Histologic Subtype | ||
| UC NOS | 12 | 3 |
| Micropapillary/Glandular Mixed | 1 | 0 |
| Glandular | 0 | 1 |
| Squamous | 3 | 0 |
|
| ||
| Metastatic Sites at Screening | ||
| Bone | 0 | 3 |
| Lung | 6 | 2 |
| Liver | 5 | 1 |
| Nodes | 14 | 1 |
| Other⸸ | 8 | 0 |
*
1 point each for ECOG>0, Hemoglobin <10g/dL, Liver metastases33
⸸
spleen, ureteral stump, L psoas, adrenal (2), body wall, thigh, vagina, peritoneal