Bladder cancer stage III Trials in Disease

Study of Pembrolizumab, Cisplatin, and Gemcitabine for Patients with Muscle-Invasive Bladder Cancer Eligible for Cisplatin Treatment

This clinical trial is investigating a treatment approach for patients with muscle-invasive bladder cancer. The study focuses on combining an immunotherapy drug called pembrolizumab with two chemotherapy drugs, cisplatin and gemcitabine. Pembrolizumab works by helping the immune system recognize and fight cancer cells more effectively. It blocks a protein called PD-1 on immune cells, allowing them to better detect and destroy cancer cells.

Main focus and goal: The main purpose of this study is to determine whether adding pembrolizumab to chemotherapy before and after surgery can improve outcomes for patients compared to chemotherapy alone with a placebo. Researchers want to see if this combination can help patients remain free from cancer events for a longer period. The study will also track overall survival rates and how many patients achieve a complete response to treatment.

Who can participate - Inclusion criteria:

• Patients with confirmed diagnosis of urothelial carcinoma (bladder cancer) that has invaded the muscle layer, with at least 50% of the tumor being made up of urothelial cells
• Cancer that has not spread to distant parts of the body, as confirmed by CT or MRI scans of the chest, abdomen, and pelvis
• Patients who are suitable candidates for radical cystectomy (surgery to remove the bladder) and pelvic lymph node dissection
• Good overall health status, able to carry out normal daily activities with little or no restriction
• Adequate organ function, meaning the liver, kidneys, and other organs are working well enough to handle the treatment
• Both male and female participants who agree to use appropriate birth control methods during the study

Who cannot participate - Exclusion criteria:

• Patients who do not have muscle-invasive bladder cancer that is eligible for cisplatin treatment
• Patients who fall outside the specified age range for the study
• Patients who do not meet the clinical trial group requirements
• Individuals considered part of a vulnerable population who might be at higher risk of harm or exploitation

How the study works: Participants are randomly assigned to one of two groups. One group receives pembrolizumab along with chemotherapy before and after surgery, while the other group receives a placebo with the same chemotherapy regimen. The medications are given through an intravenous infusion, meaning they are delivered directly into a vein. After the initial treatment phase, patients undergo surgery to remove the bladder and nearby lymph nodes. Following surgery, participants continue to be monitored through regular check-ups and tests. The study is expected to continue until June 2025.

Investigational drugs: The study uses pembrolizumab (also known as Keytruda), which is an immune checkpoint inhibitor. It is given in combination with neoadjuvant chemotherapy, which refers to chemotherapy given before surgery to help shrink the tumor and make it easier to remove. The chemotherapy drugs used are cisplatin and gemcitabine.