Nivolumab +/− Ipilimumab Before Surgery for Bladder Cancer

This trial explores whether using the immunotherapy drugs nivolumab and ipilimumab before bladder cancer surgery can safely shrink tumors, potentially enhancing the surgery's effectiveness. Researchers are testing various combinations and schedules of these drugs to determine the best approach. The trial seeks participants with muscle-invasive bladder cancer or certain upper urinary tract cancers who cannot undergo standard chemotherapy. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

The trial does not specify if you need to stop taking your current medications. However, if you are on systemic corticosteroids or other immunosuppressive medications, you must stop them at least 14 days before starting the study treatment.

Research has shown that nivolumab and ipilimumab have been studied for bladder cancer and other conditions. Nivolumab often causes side effects like tiredness, muscle pain, nausea, and loss of appetite when used for bladder cancer. Although rare, serious reactions can include lung problems and infections.

Studies indicate that nivolumab and ipilimumab can work well together. This combination has been tested in patients with advanced bladder cancer and has shown promise in shrinking tumors. However, it can also lead to serious side effects, such as inflammation in the lungs or other organs, and infections.

Unlike the standard of care for bladder cancer, which typically involves chemotherapy or surgery, the combination of Nivolumab and Ipilimumab offers a novel approach by harnessing the power of the immune system. Nivolumab is a PD-1 inhibitor, while Ipilimumab targets CTLA-4, both of which help to unleash the immune system against cancer cells. Researchers are excited about these treatments because they have the potential to work synergistically, offering a more effective response against the tumor. Additionally, this immunotherapy combination can be administered before surgery, potentially shrinking the tumor size and making surgical removal easier. This method could lead to better outcomes for patients who are ineligible for standard chemotherapy options.

Research has shown that using the drug nivolumab alone yields promising results for treating bladder cancer. For patients with muscle-invasive urothelial carcinoma, nivolumab reduced the chance of cancer returning after surgery by 30%. In this trial, some participants will receive nivolumab alone, while others will receive a combination of nivolumab and ipilimumab. When combined, these drugs have caused cancer to shrink in 38.5% of patients with advanced bladder cancer. In some studies, 21% of patients experienced partial or complete disappearance of their cancer, which extended their lives. These findings suggest that these treatments could potentially shrink bladder tumors and improve surgery outcomes.⁶⁷⁸⁹¹⁰