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NCT03294304 · ClinicalTrials.gov registry record · Phase 2
BLASST-1 (Bladder Cancer Signal Seeking Trial): Nivolumab, Gemcitabine, and Cisplatin in Treatment of Muscle Invasive Bladder Cancer (MIBC) Undergoing Cystectomy
A Phase 2 study of Muscle-invasive Bladder Cancer, sponsored by Masonic Cancer Center, University of Minnesota.
- Completed
- Registry status
- Phase 2
- Development phase
- 43
- Enrollment target
- 3
- Study locations
NCT03294304: Completed Phase 2 study of Muscle-invasive Bladder Cancer, sponsored by Masonic Cancer Center, University of Minnesota.
NCT03294304 is a Phase 2 study of Muscle-invasive Bladder Cancer that has completed, run by Masonic Cancer Center, University of Minnesota. The registered enrollment target is 43 participants, below the 1,331-participant average among 10 other Muscle-invasive Bladder Cancer trials with a reported enrollment target (97% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03294304, a Phase 2 study of Muscle-invasive Bladder Cancer, has completed, sponsored by Masonic Cancer Center, University of Minnesota.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 43 participants
- Enrollment target
- 3
- Study locations
Study Summary
This is a multi-center Phase II study to determine the safety and efficacy of nivolumab when given in combination with cisplatin and gemcitabine as neoadjuvant treatment in patients with muscle-invasive bladder cancer (MIBC) prior to standard of care radical cystectomy. Patients will receive neoadjuvant treatment with nivolumab in combination with gemcitabine-cisplatin (GC) every 3 weeks for 4 treatment cycles over 12 weeks followed by standard of care radical cystectomy.
Primary Outcome
Incidence of Measurable Disease "pT" in the TNM staging system refers to the size and extend of the primary tumor. The higher the number after the T, the larger the tumor or the more it has grown into nearby tissues. T's may be further divided to provide more detail, such as T3a and T3b. pTa refers to noninvasive papillary carcinoma. pTis refers to carcinoma in situ (CIS) or a "flat tumor" stage. pN refers to lymph nodes. N0 mans cancer has not spread to nearby lymph nodes.
Conditions Studied
Interventions
- DRUG Cisplatin
- DRUG Nivolumab
- DRUG Gemcitabine
Study Locations (3)
Massachusetts
- Dana-Farber Cancer Institute - Boston
Minnesota
- Masonic Cancer Center - University of Minnesota - Minneapolis
Utah
- Huntsman Cancer Institute - University of Utah Health - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2018-01-29 |
| Est. Completion | 2021-07-01 |
| Phase | Phase 2 |
What the finished NCT03294304 record still lists
NCT03294304 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 1,331-participant average among 10 other Muscle-invasive Bladder Cancer trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Muscle-invasive Bladder Cancer appearing as the primary indexed condition, and to 3 interventions - of which Cisplatin is the first listed.
NCT03294304 reports a single indexed study location in Massachusetts, Minnesota, Utah.
Frequently Asked Questions
What is clinical trial NCT03294304 about?
NCT03294304 is a clinical study titled "BLASST-1 (Bladder Cancer Signal Seeking Trial): Nivolumab, Gemcitabine, and Cisplatin in Treatment of Muscle Invasive Bladder Cancer (MIBC) Undergoing Cystectomy". This is a multi-center Phase II study to determine the safety and efficacy of nivolumab when given in combination with cisplatin and gemcitabine as neoadjuvant treatment in patients with muscle-invasive bladder cancer (MIBC) prior to standard of care radical cystectomy. Patients will receive neoadju...
What is the current status of trial NCT03294304?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 43 participants. The study started on 2018-01-29. Estimated completion is 2021-07-01.
What conditions does trial NCT03294304 study?
This clinical trial studies the following conditions: Muscle-invasive Bladder Cancer.
What interventions are being tested in trial NCT03294304?
The interventions under investigation include: Cisplatin (DRUG), Nivolumab (DRUG), Gemcitabine (DRUG).
Who is sponsoring clinical trial NCT03294304?
This trial is sponsored by Masonic Cancer Center, University of Minnesota, which has 249 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03294304 being conducted?
This trial has 3 study locations across Massachusetts, Minnesota, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03294304's enrollment target sits among peer trials
43 8th of 10 higher than 3 of 10 other Muscle-invasive Bladder Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Muscle-invasive 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.
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