Study on Sasanlimab for People with Early-Stage Bladder Cancer

Program Overview

The aim of this study is to understand how safe and effective sasanlimab is for treating early-stage bladder cancer that hasn't spread outside the bladder. The study is divided into two parts. Part A, which is now closed, involved participants with high-risk bladder cancer who had surgery to remove the cancer. They were divided into three groups: one received sasanlimab and BCG, another received sasanlimab and BCG for six weeks, and the third received only BCG. Part B, which is no longer enrolling new participants, focused on those whose cancer did not respond to BCG treatment. All participants in Part B received sasanlimab. The decision to stop enrolling in Part B was not due to safety concerns.

Description

This study, called CREST, is testing a combination of sasanlimab and different BCG treatment plans to see how well they work for people with early-stage bladder cancer. The study is in Phase 3 and has two main groups. Group A included people who had not received BCG before and were divided into three treatment arms: two received sasanlimab with BCG, and one received only BCG. Group B included people whose cancer did not respond to BCG. They were divided into two subgroups based on their type of bladder cancer and received sasanlimab. The study aims to show that sasanlimab with BCG is better than BCG alone in preventing cancer from coming back in people with high-risk bladder cancer. It also aims to see how well sasanlimab works on its own for those whose cancer did not respond to BCG. Enrollment for Part B has been stopped, but not for safety reasons.

Eligibility Criteria

Locations