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NCT04165317 · ClinicalTrials.gov registry record · Phase 3
A Study of Sasanlimab in People With Non-muscle Invasive Bladder Cancer
A Phase 3 study of Non-muscle Invasive Bladder Cancer, sponsored by Pfizer.
- Active
- Registry status
- Phase 3
- Development phase
- 1,068
- Enrollment target
- 20
- Study locations
NCT04165317: Active Phase 3 study of Non-muscle Invasive Bladder Cancer, sponsored by Pfizer.
NCT04165317 is a Phase 3 study of Non-muscle Invasive Bladder Cancer that is active but no longer recruiting, run by Pfizer. The registered enrollment target is 1,068 participants, above the 191-participant average among 30 other Non-muscle Invasive Bladder Cancer trials with a reported enrollment target (459% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04165317, a Phase 3 study of Non-muscle Invasive Bladder Cancer, is active but no longer recruiting, sponsored by Pfizer.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,068 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to learn about the safety and effects of the study medicine (sasanlimab) in people with non-muscle invasive bladder cancer. This study is seeking participants whose bladder cancer is still in early stages, has not spread outside of the bladder, has been removed with surgery, and is high risk (Part A) or was previously treated with BCG (Bacillus Calmette Guerin), a standard treatment for bladder cancer (Part B). In Part A (enrollment closed), each participant was assigned to one of three study treatment groups. * One group is given sasanlimab and BCG at the study clinic. * The second group is given sasanlimab and BCG at the study clinic. This group will receive BCG for the first six weeks only. * The third group is given BCG only and will not receive sasanlimab. In Part B of the study, each new participant will be assigned to a study treatment group based on the type of their bladder tumor. \- Both groups will be given sasanlimab at the study clinic. On August 31, 2022, the Sponsor announced the discontinuation of enrollment to Part B. The decision to discontinue enrollment to Part B was not made for safety reasons.
Primary Outcome
EFS: time from randomization till recurrence of high-grade disease, progression of disease, persistence of carcinoma in situ (CIS), death due to any cause, whichever occurred first. Recurrence of high-grade disease: re-appearance of high-grade disease after randomization/study intervention initiation, re-appearance of high-grade disease after complete response (CR) for CIS participants or re-appearance of high-grade disease before CR for CIS participants and concurrent papillary disease at basel
Conditions Studied
Interventions
- DRUG PF-06801591
- DRUG Bacillus Calmette-Guerin
Study Locations (20)
California
- Koman Family Outpatient Pavilion - La Jolla
- Sulpizio Cardiovascular Center at UC San Diego Health - La Jolla
- UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion) - La Jolla
- UC San Diego Moores Cancer Center - La Jolla
- University of California Irvine Medical Center - Orange
- UC San Diego Medical Center - Hillcrest - San Diego
Illinois
- John H. Stroger, Jr. Hospital of Cook County - Chicago
- DuPage Medical Group - Lisle
- DuPage Medical Group Ambulatory Surgery Center - Lombard
- DuPage Medical Group - Lombard
- Edward Hospital - Naperville
Florida
- Urological Research Network Corp - Hialeah
- UF Health Jacksonville - Jacksonville
- UF Health North - Jacksonville
Arizona
- Arizona Urology Specialists - Tucson
Arkansas
- Arkansas Urology - Little Rock
Colorado
- The Urology Center of Colorado - Denver
Louisiana
- Ochsner LSU Health Shreveport - Regional Urology - Shreveport
Maryland
- Chesapeake Urology Research Associates - Hanover
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,068 participants |
| Start Date | 2019-12-30 |
| Est. Completion | 2026-12-02 |
| Phase | Phase 3 |
What the registry record for NCT04165317 still lists
NCT04165317 is an interventional study that assigns participants to a tested intervention. Its 1,068 participants enrollment target places it among the larger protocols in the corpus, above the 191-participant average among 30 other Non-muscle Invasive Bladder Cancer trials with a reported enrollment target (459% higher).
The record links to 1 condition, with Non-muscle Invasive Bladder Cancer appearing as the primary indexed condition, and to 2 interventions - of which PF-06801591 is the first listed.
NCT04165317 names 20 study sites across 9 states, led by California, Illinois, Florida.
Frequently Asked Questions
What is clinical trial NCT04165317 about?
NCT04165317 is a clinical study titled "A Study of Sasanlimab in People With Non-muscle Invasive Bladder Cancer". The purpose of this study is to learn about the safety and effects of the study medicine (sasanlimab) in people with non-muscle invasive bladder cancer. This study is seeking participants whose bladder cancer is still in early stages, has not spread outside of the bladder, has been removed with surg...
What is the current status of trial NCT04165317?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,068 participants. The study started on 2019-12-30. Estimated completion is 2026-12-02.
What conditions does trial NCT04165317 study?
This clinical trial studies the following conditions: Non-muscle Invasive Bladder Cancer.
What interventions are being tested in trial NCT04165317?
The interventions under investigation include: PF-06801591 (DRUG), Bacillus Calmette-Guerin (DRUG).
Who is sponsoring clinical trial NCT04165317?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04165317 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04165317's enrollment target sits among peer trials
1,068 1st of 30 higher than 30 of 30 other Non-muscle Invasive Bladder Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-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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