A Study of Sasanlimab in People With Non-muscle Invasive Bladder Cancer (NCT04165317)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Arizona Urology Specialists — Tucson, Arizona
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (194 Sites)
Showing the first 25 of 194 sites.
- Arizona Urology Specialists — Tucson, Arizona
- Arkansas Urology — Little Rock, Arkansas
- Koman Family Outpatient Pavilion — La Jolla, California
- Sulpizio Cardiovascular Center at UC San Diego Health — La Jolla, California
- UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion) — La Jolla, California
- UC San Diego Moores Cancer Center — La Jolla, California
- University of California Irvine Medical Center — Orange, California
- UC San Diego Medical Center - Hillcrest — San Diego, California
- The Urology Center of Colorado — Denver, Colorado
- Urological Research Network Corp — Hialeah, Florida
- UF Health Jacksonville — Jacksonville, Florida
- UF Health North — Jacksonville, Florida
- John H. Stroger, Jr. Hospital of Cook County — Chicago, Illinois
- DuPage Medical Group — Lisle, Illinois
- DuPage Medical Group Ambulatory Surgery Center — Lombard, Illinois
- DuPage Medical Group — Lombard, Illinois
- Edward Hospital — Naperville, Illinois
- Ochsner LSU Health Shreveport - Regional Urology — Shreveport, Louisiana
- Chesapeake Urology Research Associates — Hanover, Maryland
- Michigan Institute of Urology, PC — Troy, Michigan
- Bellevue Hospital — New York, New York
- Laura & Isaac Perlmutter Cancer Center at NYU Langone Health — New York, New York
- NYU Langone Medical Center (Tisch Hospital) — New York, New York
- NYU Langone Health Urology Associates — New York, New York
- Icahn School of Medicine at Mount Sinai — New York, New York
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Non-muscle Invasive Bladder Cancer
- A Study of Intravesical BCG in Combination With ALT-803 in Patients With Non-Muscle Invasive Bladder Cancer — Birmingham, Alabama
- Study of CG0070 After Transurethral Resection in Patients With IR NMIBC — Tampa, Florida
- Trial of Encapsulated Rapamycin (eRapa) for Bladder Cancer Prevention — Dallas, Texas
- A Trial of Durvalumab (MEDI4736) Plus Monalizumab in Non-Muscle-Invasive Bladder Cancer — Tampa, Florida
- Study of 2141-V11 in People With Non-muscle Invasive Bladder Cancer That Did Not Respond to Standard Treatment — Basking Ridge, New Jersey
Explore by condition: All Non-muscle Invasive Bladder Cancer clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.