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NCT02449239 · ClinicalTrials.gov registry record · Phase 3
Vicinium Treatment for Subjects With Non-muscle Invasive Bladder Cancer Previously Treated With BCG
A Phase 3 study of Bladder Cancer, sponsored by Sesen Bio.
- Completed
- Registry status
- Phase 3
- Development phase
- 133
- Enrollment target
- 20
- Study locations
NCT02449239: Completed Phase 3 study of Bladder Cancer, sponsored by Sesen Bio.
NCT02449239 is a Phase 3 study of Bladder Cancer that has completed, run by Sesen Bio. The registered enrollment target is 133 participants, below the 12,753-participant average among 175 other Bladder Cancer trials with a reported enrollment target (99% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02449239, a Phase 3 study of Bladder Cancer, has completed, sponsored by Sesen Bio.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 133 participants
- Enrollment target
- 20
- Study locations
Study Summary
Because of the high risk for development of muscle invasive disease, cystectomy is recommended for CIS, high-grade Ta and T1 patients who experience disease recurrence following intravesical therapy. Vicinium is an experimental agent that may provide an alternative to cystectomy
Primary Outcome
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
Conditions Studied
Interventions
- BIOLOGICAL Vicinium
Study Locations (20)
California
- - Los Angeles
- - Los Angeles
- - Los Angeles
- - Los Angeles
- - Redwood City
- - San Bernardino
- - Sherman Oaks
- - Torrance
Florida
- - Bradenton
- - Daytona Beach
- - Orlando
- - St. Petersburg
- - Tampa
- - Wellington
Arizona
- - Phoenix
- - Tucson
Alabama
- - Birmingham
Arkansas
- - Little Rock
Colorado
- - Englewood
District of Columbia
- - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 133 participants |
| Start Date | 2015-08 |
| Est. Completion | 2022-05 |
| Phase | Phase 3 |
What the finished NCT02449239 record still lists
NCT02449239 is an interventional study that assigns participants to a tested intervention. The registered 133 participants enrollment target is mid-sized for trials with a published cap, below the 12,753-participant average among 175 other Bladder Cancer trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Bladder Cancer appearing as the primary indexed condition, and to 1 intervention - of which Vicinium is the first listed.
NCT02449239 names 20 study sites across 7 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT02449239 about?
NCT02449239 is a clinical study titled "Vicinium Treatment for Subjects With Non-muscle Invasive Bladder Cancer Previously Treated With BCG". Because of the high risk for development of muscle invasive disease, cystectomy is recommended for CIS, high-grade Ta and T1 patients who experience disease recurrence following intravesical therapy. Vicinium is an experimental agent that may provide an alternative to cystectomy
What is the current status of trial NCT02449239?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 133 participants. The study started on 2015-08. Estimated completion is 2022-05.
What conditions does trial NCT02449239 study?
This clinical trial studies the following conditions: Bladder Cancer.
What interventions are being tested in trial NCT02449239?
The interventions under investigation include: Vicinium (BIOLOGICAL).
Who is sponsoring clinical trial NCT02449239?
This trial is sponsored by Sesen Bio, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02449239 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Bladder Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02449239's enrollment target sits among peer trials
133 74th of 175 higher than 101 of 175 other Bladder Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bladder Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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