A Study of Sasanlimab in People With Non-muscle Invasive Bladder Cancer
Public ClinicalTrials.gov record NCT04165317. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Multinational, Randomized, Open-Label, Three Parallel-Arm Study of PF-06801591, an Anti-PD-1 Antibody, in Combination With Bacillus Calmette-Guerin (BCG Induction With or Without BCG Maintenance) Versus BCG (Induction and Maintenance) in Participants With High-Risk, BCG-Naïve Non-Muscle Invasive Bladder Cancer or PF-06801591 as a Single Agent in Participants With BCG-Unresponsive NMIBC
Study identification
- NCT ID
- NCT04165317
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Pfizer
- Industry
- Enrollment
- 1,068 participants
Conditions and interventions
Conditions
Interventions
- Bacillus Calmette-Guerin Drug
- PF-06801591 Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 29, 2019
- Primary completion
- Dec 1, 2024
- Completion
- Dec 1, 2026
- Last update posted
- Jan 21, 2026
2019 – 2026
United States locations
- U.S. sites
- 44
- U.S. states
- 14
- U.S. cities
- 27
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Urology Specialists | Tucson | Arizona | 85741 | — |
| Arkansas Urology | Little Rock | Arkansas | 72211 | — |
| Koman Family Outpatient Pavilion | La Jolla | California | 92037 | — |
| Sulpizio Cardiovascular Center at UC San Diego Health | La Jolla | California | 92037 | — |
| UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion) | La Jolla | California | 92037 | — |
| UC San Diego Moores Cancer Center | La Jolla | California | 92093 | — |
| University of California Irvine Medical Center | Orange | California | 92868 | — |
| UC San Diego Medical Center - Hillcrest | San Diego | California | 92103 | — |
| The Urology Center of Colorado | Denver | Colorado | 80211 | — |
| Urological Research Network Corp | Hialeah | Florida | 33016 | — |
| UF Health Jacksonville | Jacksonville | Florida | 32209 | — |
| UF Health North | Jacksonville | Florida | 32218 | — |
| John H. Stroger, Jr. Hospital of Cook County | Chicago | Illinois | 60612 | — |
| DuPage Medical Group | Lisle | Illinois | 60532 | — |
| DuPage Medical Group Ambulatory Surgery Center | Lombard | Illinois | 60148 | — |
| DuPage Medical Group | Lombard | Illinois | 60148 | — |
| Edward Hospital | Naperville | Illinois | 60540 | — |
| Ochsner LSU Health Shreveport - Regional Urology | Shreveport | Louisiana | 71106 | — |
| Chesapeake Urology Research Associates | Hanover | Maryland | 21076 | — |
| Michigan Institute of Urology, PC | Troy | Michigan | 48084 | — |
| Bellevue Hospital | New York | New York | 10016 | — |
| Laura & Isaac Perlmutter Cancer Center at NYU Langone Health | New York | New York | 10016 | — |
| NYU Langone Medical Center (Tisch Hospital) | New York | New York | 10016 | — |
| NYU Langone Health Urology Associates | New York | New York | 10017 | — |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | — |
| Mount Sinai Hospital | New York | New York | 10029 | — |
| Premier Medical Group of the Hudson Valley PC | Poughkeepsie | New York | 12603 | — |
| Associated Medical Professionals of New York, PLLC | Syracuse | New York | 13210 | — |
| Montefiore Medical Center - Montefiore Medical Park | The Bronx | New York | 10461 | — |
| Montefiore Medical Center - Oncology Investigational Services | The Bronx | New York | 10461 | — |
| VA Portland Healthcare System | Portland | Oregon | 97239 | — |
| AUC Urologists LLC | Murrells Inlet | South Carolina | 29576 | — |
| Carolina Urologic Research Center | Myrtle Beach | South Carolina | 29572 | — |
| Parkway Surgery Center | Myrtle Beach | South Carolina | 29572 | — |
| Atlantic Urology Clinics South Strand Office | Myrtle Beach | South Carolina | 29588. | — |
| Urology Clinics of North Texas | Dallas | Texas | 75231 | — |
| Baylor University Medical Center | Dallas | Texas | 75246 | — |
| Urology Clinics of North Texas | Dallas | Texas | 75246 | — |
| Houston Metro Urology | Houston | Texas | 77027 | — |
| Houston Methodist Hospital | Houston | Texas | 77030 | — |
| Urology San Antonio PA | San Antonio | Texas | 78229 | — |
| Sentara Norfolk General Hospital | Norfolk | Virginia | 23507 | — |
| Chesapeake Regional Surgery Center - Virginia Beach | Virginia Beach | Virginia | 23462 | — |
| Urology of Virginia, PLLC | Virginia Beach | Virginia | 23462 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 150 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04165317, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 21, 2026 · Synced May 7, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04165317 live on ClinicalTrials.gov.