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A Study of Sasanlimab in People With Non-muscle Invasive Bladder Cancer
NCT04165317 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04165317
The ClinicalTrials.gov registry entry for NCT04165317 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,068 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 769 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04165317 reports 20 study locations spanning 9 distinct geographic areas — top geographies include California, Illinois, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04165317?
The interventions under investigation include: PF-06801591 (DRUG), Bacillus Calmette-Guerin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04165317?
This trial is sponsored by Pfizer, which has 769 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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