A Study of Sasanlimab in People With Non-muscle Invasive Bladder Cancer

Running, not enrolling · Phase 3

Conditions studied: Non-muscle Invasive Bladder Cancer

In brief

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.

Key facts

Study ID

NCT04165317

Run by

Pfizer

People needed

1068

Starts

2019-12-30

Expected to finish

2026-12-02

Last updated by the study team

2026-01-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histological confirmed diagnosis of high risk non-muscle invasive transitional cell carcinoma (TCC) of the urothelium of the urinary bladder (tumors of mixed transitional/non-transitional cell histology are allowed, but TCC must be the predominant histology)
• Complete resection of all Ta/T1 papillary disease (including participants with concurrent CIS), with most recent positive TURBT occurring within 12 weeks prior to randomization or study intervention. A second TURBT must have been performed if indicated according to the current locally applicable guidelines, ie, American Urological Association, European Association of Urology
• (Cohorts B1 and B2 only): Histological confirmed diagnosis of BCG-unresponsive high-risk, non-muscle invasive TCC of the urothelium within 12 months (CIS only) or 6 months (recurrent Ta/T1 disease) of completion of adequate BCG therapy.
• Have refused or are ineligible for radical cystectomy

You may not qualify if…

• Evidence of muscle-invasive, locally advanced or metastatic urothelial cancer or concurrent extravesical, non-muscle invasive TCC of the urothelium
• (Cohort A only): Intravesical BCG therapy within 2 years prior to randomization. Prior intravesical chemotherapy for NMIBC is allowed.
• (Cohorts B1 and B2 only): Any systemic or intravesical chemotherapy or immunotherapy from the time of most recent positive TURBT to initiation of study intervention.
• Prior immunotherapy with anti PD-1, anti PD-L1, anti PD-L2, or anti cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody
• Prior treatment with immunostimulatory agents including interleukin (IL)-2, IL-15, interferon (INF)
• Prior radiation therapy to the bladder
• (Cohorts B1 and B2 only): Prior participation in Cohort A of this study.

Where it is running

• Arkansas Urology — Little Rock, Arkansas, United States
• Koman Family Outpatient Pavilion — La Jolla, California, United States
• Sulpizio Cardiovascular Center at UC San Diego Health — La Jolla, California, United States
• UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion) — La Jolla, California, United States
• UC San Diego Moores Cancer Center — La Jolla, California, United States
• University of California Irvine Medical Center — Orange, California, United States
• UC San Diego Medical Center - Hillcrest — San Diego, California, United States
• The Urology Center of Colorado — Denver, Colorado, United States
• Urological Research Network Corp — Hialeah, Florida, United States
• UF Health Jacksonville — Jacksonville, Florida, United States
• UF Health North — Jacksonville, Florida, United States
• John H. Stroger, Jr. Hospital of Cook County — Chicago, Illinois, United States
• DuPage Medical Group — Lisle, Illinois, United States
• DuPage Medical Group Ambulatory Surgery Center — Lombard, Illinois, United States
• DuPage Medical Group — Lombard, Illinois, United States
• Edward Hospital — Naperville, Illinois, United States
• Ochsner LSU Health Shreveport - Regional Urology — Shreveport, Louisiana, United States
• Chesapeake Urology Research Associates — Hanover, Maryland, United States
• Michigan Institute of Urology, PC — Troy, Michigan, United States
• Bellevue Hospital — New York, New York, United States
• Laura & Isaac Perlmutter Cancer Center at NYU Langone Health — New York, New York, United States
• NYU Langone Medical Center (Tisch Hospital) — New York, New York, United States
• NYU Langone Health Urology Associates — New York, New York, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• Arizona Urology Specialists — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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