Ongoing Clinical Trials for Bladder Transitional Cell Carcinoma Stage II
This article provides information about ongoing clinical trials for bladder transitional cell carcinoma stage II, a type of bladder cancer where cancer cells have invaded the muscle layer of the bladder wall. Currently, there is 1 clinical trial investigating new treatment approaches for patients who have completed standard therapy, focusing on immunotherapy to help prevent cancer recurrence.
Clinical trial locations
Study on Durvalumab with Trimodality Therapy for Patients with Muscle-Invasive Bladder Cancer
This clinical trial is investigating whether adding an immunotherapy medication called Durvalumab after standard treatment can help patients with muscle-invasive bladder cancer stay cancer-free for longer periods.
Who can participate:
This study is looking for patients who meet specific criteria. You may be eligible if you:
- Have been diagnosed with urothelial carcinoma of the bladder that has invaded the muscle layer (stage T2-T4a N0M0), meaning the cancer has not spread to lymph nodes or other parts of the body
- Are 18 years of age or older with a life expectancy of more than 6 months
- Have recently completed trimodality therapy, which includes surgery, chemotherapy, and radiation therapy, and can start the study treatment within 42 days of finishing these treatments
- Have had a recent CT scan (within 8 weeks) showing no signs of cancer spread
- Have adequate kidney function with a creatinine clearance of at least 30 ml/min, which measures how well your kidneys are working
- Have healthy blood cell counts and adequate liver function
- Have an ECOG performance status of 0-2, which is a way of measuring how the disease affects your daily activities, and weigh more than 30 kg
- Are willing to use effective birth control during treatment and for 3 months afterward if you are of childbearing potential
Who cannot participate:
You may not be eligible for this study if you:
- Have a different type of cancer that is not muscle-invasive bladder cancer
- Did not receive the standard trimodality therapy (surgery, chemotherapy, and radiation)
- Are pregnant or breastfeeding
- Are participating in another clinical trial at the same time
- Have had severe allergic reactions to similar medications in the past
- Have a history of certain immune system disorders
- Have other serious health conditions that might interfere with the study
- Are unable to follow study procedures or attend required visits
- Have received certain medications or treatments that might affect the study results
What the trial involves:
The main goal of this trial is to determine if Durvalumab can improve disease-free survival, which means the time you remain free from cancer after completing standard treatment. After you finish trimodality therapy, you will be randomly assigned to receive either Durvalumab or no additional treatment (surveillance only). This helps researchers compare whether adding the medication makes a difference.
The study will also look at other important factors, including how well the cancer is controlled in the bladder area, overall survival rates, and how the treatment affects your quality of life. Regular follow-up appointments will be scheduled to monitor your health and response to treatment.
About the investigational drug:
Durvalumab, also known by its code name MEDI4736 or brand name IMFINZI, is an immunotherapy medication. It works by blocking a protein called PD-L1, which helps your immune system recognize and attack cancer cells more effectively. The medication is given as an infusion directly into your bloodstream in a hospital or clinical setting. It belongs to a class of medications called immune checkpoint inhibitors, which enhance your body’s natural defenses to fight cancer.
The trial is expected to continue until early 2026, with participants being closely monitored throughout the study period.
Summary
Currently, there is one ongoing clinical trial for bladder transitional cell carcinoma stage II, located in Spain. This trial focuses on investigating the benefits of adding immunotherapy with Durvalumab after patients complete standard trimodality therapy. The study aims to determine whether this additional treatment can help patients remain cancer-free for longer periods and improve overall outcomes. The trial represents an important step in exploring new treatment approaches for patients with muscle-invasive bladder cancer who have completed their initial therapy.
