This clinical trial is focused on studying the treatment of muscle-invasive bladder cancer, a type of cancer that affects the bladder and requires significant medical intervention. The study involves a new treatment approach using a combination of medications. One of the medications being tested is called visugromab (CTL-002), which is an antibody designed to target a specific protein involved in cancer growth. This medication will be used alongside another type of drug known as an anti-PD-1 checkpoint inhibitor, which helps the immune system recognize and attack cancer cells. The well-known drug nivolumab is an example of an anti-PD-1 checkpoint inhibitor that may be used in this study. Additionally, some participants may receive a placebo as part of the trial.

The purpose of this study is to evaluate the effectiveness of the combination of visugromab and an anti-PD-1 checkpoint inhibitor compared to the anti-PD-1 checkpoint inhibitor alone. Participants in the study will receive these treatments through an intravenous infusion, which means the medication is delivered directly into the bloodstream. The study will last for a period of up to 12 months, during which participants will be closely monitored by healthcare professionals. The study aims to assess how well the treatment works in reducing the size of the tumor and improving the overall health of the participants.

Throughout the study, participants will undergo various assessments, including imaging tests like computed tomography (CT) and magnetic resonance imaging (MRI), to evaluate the response of the cancer to the treatment. The study will also monitor for any side effects or adverse reactions to the medications. The ultimate goal is to determine if this new combination of treatments can provide a more effective option for patients with muscle-invasive bladder cancer who are unable or unwilling to receive traditional chemotherapy treatments.