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

Brief summary (registry, in English)

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.

What you commit to

• Study type: Interventional · Phase 3
• Participants enrolled: 1068
• From 30 Dec 2019 to the primary completion date, 2 Dec 2024
• 174 sites in 14 countries
• Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (174)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Related publications

• Sasanlimab taken together with Bacillus Calmette-Guérin (BCG) compared with BCG alone in people with high-risk non-muscle invasive bladder cancer: a plain language summary.Future Oncol · 2026 · PMID 42177753