| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02449239 | Vicinium Treatment for Subjects With Non-muscle Invasive Bladder Cancer Previously Treated With BCG | PHASE3 | COMPLETED | 133 | — | — | Aug 1, 2015 | May 1, 2022 | Jul 24, 2023 | 70 | United States, Canada |
Complete response rate at 3 months in patients with CIS with or without resected papillary disease following initiation of Vicinium therapy. This is the percentage of patients who were free of high-grade disease at the post-induction (3 month) assessment timepoint. A patient was considered to have a complete response if the urine cytology was reported as negative or atypical AND the cystoscopy was reported as normal or any suspicious areas were deemed negative for high-grade disease upon biopsy assessment.
Duration of complete response in participants with CIS with or without resected papillary disease who achieved a complete response at the post-induction (3 month) assessment. This is the number of days from the date of first occurrence of complete response to the date of documented treatment failure or death, whichever occurs first
| Arm | Type | Description |
|---|---|---|
| Vicinium | EXPERIMENTAL | Induction - 30 mg of Vicinium in 50 mL of saline administered twice weekly (BIW) for 6 weeks followed by once weekly for 6 weeks, for a total of 12 weeks. Maintenance - 30 mg of Vicinium in 50 mL of saline administered once weekly every other week for up to 104 weeks. |
| Name | Type | Description |
|---|---|---|
| Vicinium | BIOLOGICAL | Intravesical administration |
Inclusion Criteria: 1. Histologically-confirmed non muscle-invasive urothelial carcinoma (transitional cell carcinoma) of the bladder as follows: 1. CIS (with or without papillary disease) OR 2. Any grade T1 papillary disease OR 3. High-grade Ta papillary disease based on a biopsy within ...