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ACTIVE NOT RECRUITING

NCT04165317

PHASE3

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

Sponsor: Pfizer

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1068

Start Date

2019-12-30

Completion Date

2026-12-02

Last Updated

2026-01-22

Healthy Volunteers

Conditions

Non-muscle Invasive Bladder Cancer

Interventions

DRUG

PF-06801591

A monoclonal antibody (mAb) that blocks the interaction between PD-1 and PD-L1/PD-L2.

DRUG

Bacillus Calmette-Guerin

Immunotherapy treatment approved by FDA for patients with high-risk non-muscle invasive bladder cancer

Locations (194)

Arizona Urology Specialists

Tucson, Arizona, United States

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