Study on Additional Treatments After EV and Pembrolizumab for Advanced Bladder Cancer (REINFORCE Trial)

Program Overview

This study is testing a new approach for treating advanced bladder cancer that has responded to initial treatment with enfortumab vedotin and pembrolizumab but still has some cancer left. The trial is looking at whether adding treatments like radiation or surgery can safely remove the remaining cancer and delay its return. Radiation therapy uses high-energy rays to target and destroy cancer cells, while surgery involves removing the bladder. The study also uses special tests to check for cancer markers in blood and urine, which may help decide who benefits most from these additional treatments.

Description

This trial involves a single group of patients who have responded well to initial treatment with enfortumab vedotin and pembrolizumab. Patients with no remaining cancer in the bladder may choose to have additional local treatments like radiation or surgery, but it's not required. Those with remaining cancer in the bladder will receive either radiation or surgery, based on a decision made with their doctor. Radiation therapy may be combined with chemotherapy to enhance its effects. Patients with cancer outside the bladder will receive targeted radiation therapy.

The study includes various tests and procedures, such as CT, MRI, or PET scans, and collecting blood and urine samples. Patients may also have a procedure to remove bladder tumors and undergo bladder examinations during follow-up. After completing the study treatment, patients will have follow-up visits every three months for up to a year.

Eligibility Criteria

Locations