Ongoing Clinical Trials for Recurrent Bladder Cancer
Currently, there is 1 ongoing clinical trial for recurrent bladder cancer focusing on preventing cancer progression in high-risk non-muscle invasive cases. This trial is testing a BCG-based immunotherapy treatment and is taking place in Spain.
Clinical trial locations
Study on Mycobacterium Bovis Bacillus Calmette-Guérin for High-risk Non-muscle Invasive Bladder Cancer Patients
This trial is investigating a treatment for high-risk non-muscle invasive bladder cancer that has either returned or is newly diagnosed. The study focuses on cancer that remains in the bladder lining but hasn’t yet invaded the muscle layer of the bladder wall.
Main inclusion criteria:
- Adults aged between 18 and 85 years
- Diagnosed with a high-risk urothelial tumor classified as Ta-T1 and GIIb or GIII
- Risk of cancer recurrence or progression of 7 points or higher according to the CUETO risk assessment system
- Ability to provide informed consent before beginning any study activities
Main exclusion criteria:
- History of other cancers within the past 5 years, except non-melanoma skin cancer
- Active infections requiring antibiotic treatment
- Known allergy to BCG bacteria
- Weakened immune system
- Pregnancy or breastfeeding
- Recent major surgery within the last 4 weeks
- History of drug or alcohol abuse within the past 2 years
Trial focus and goals:
The main goal of this study is to assess how well patients respond to the treatment in terms of progression-free survival, which means measuring how long patients live without their cancer getting worse. The trial will monitor participants over time, specifically looking at cancer progression rates at 12 and 24 months after the last tumor removal. Researchers will also evaluate the overall survival without the disease returning, assess patients’ quality of life through questionnaires, and analyze the body’s immune response by testing urine samples for specific immune markers.
Investigational treatment:
The treatment being tested is IMUNO BCG Moreau RJ, which is made from a weakened strain of bacteria called Mycobacterium bovis Bacillus Calmette-Guérin, specifically the Moreau Rio de Janeiro strain. This is a type of immunotherapy that works by stimulating the body’s own immune system to attack cancer cells. The treatment is administered directly into the bladder through a catheter, a method called intravesical therapy. The weakened bacteria cannot cause disease but can trigger an immune response that targets the cancer cells in the bladder lining. The study will carefully monitor any side effects or adverse reactions throughout the treatment period.
Summary
Currently, only one clinical trial is actively recruiting patients with recurrent bladder cancer, specifically focused on high-risk non-muscle invasive cases. This trial is being conducted in Spain and represents an important effort to prevent cancer progression using immunotherapy. The study focuses on IMUNO BCG Moreau RJ, a BCG-based treatment that harnesses the body’s immune system to fight cancer cells. The trial emphasizes long-term monitoring, with follow-up assessments at 12 and 24 months, and includes quality of life evaluations alongside traditional medical outcomes. Patients interested in participating should meet specific age and diagnostic criteria and must not have certain medical conditions that could interfere with treatment safety.