Ongoing Clinical Trials for Bladder Transitional Cell Carcinoma Stage III
Currently, there are 2 ongoing clinical trials investigating new treatment approaches for patients with Bladder Transitional Cell Carcinoma Stage III. These studies are evaluating immunotherapy medications that help the body’s immune system fight cancer, including atezolizumab and durvalumab, either as continuation therapy or following standard treatment approaches.
Clinical trial locations
- Austria
- Czechia
- France
- Hungary
- Poland
- Spain
Long-Term Study for Cancer Patients Using Atezolizumab Therapy
This trial provides continued access to atezolizumab (marketed as Tecentriq) for patients who participated in previous studies sponsored by Genentech or F. Hoffmann-La Roche Ltd and were benefiting from the treatment. The medication is administered as an intravenous infusion at a dose of 1,200 mg.
Main inclusion criteria: Patients must have cancer and have been receiving atezolizumab-based therapy or a comparator treatment in a previous study. They must still be benefiting from the treatment when the original study ends and be eligible to continue therapy. The first dose in this study must be received within 7 days after the allowed break from the previous study. Women of childbearing age must have a negative pregnancy test within 7 days before starting treatment. The study also includes patients from the IMpower133 study who are in the follow-up phase and have stopped treatment but have local access to atezolizumab.
Main exclusion criteria: Patients who are not currently receiving the study treatment at the time their original study ends, or who have local access to the treatment outside of the study, are not eligible.
Focus and goal: The trial aims to ensure that patients who were benefiting from atezolizumab can continue their treatment safely while monitoring long-term effects. The study tracks serious adverse events, their severity, and overall survival, particularly for patients from the IMpower133 study. This continuation study is expected to run until March 2030.
Investigational drug: Atezolizumab is an immunotherapy medication that helps the body’s immune system fight cancer by blocking a protein called PD-L1, which prevents the immune system from attacking cancer cells. This immune checkpoint inhibitor allows the immune system to better detect and destroy cancer cells.
Study on Durvalumab with Trimodality Therapy for Patients with Muscle-Invasive Bladder Cancer
This trial investigates whether adding durvalumab (also known as MEDI4736 or IMFINZI) after standard treatment can improve the time patients remain free from cancer. The medication is administered as an intravenous infusion.
Main inclusion criteria: Patients must have a confirmed diagnosis of urothelial carcinoma of the bladder at stage T2-T4a N0M0, meaning the cancer has invaded the muscle layer but has not spread to lymph nodes or other parts of the body. They must have completed trimodality therapy (surgery, chemotherapy, and radiation therapy) before joining the study, with study treatment starting within 42 days after finishing these treatments. A CT scan within 8 weeks of enrollment must show no signs of cancer spread. Patients must be at least 18 years old, have a life expectancy of more than 6 months, weigh more than 30 kg, and have an ECOG performance status of 0-2. They must also have adequate blood cell counts, kidney function with creatinine clearance of at least 30 ml/min, and adequate liver function. Patients of childbearing potential must agree to use effective birth control during and for 3 months after treatment.
Main exclusion criteria: Patients with cancer types other than muscle-invasive bladder cancer, those who have not received standard trimodality therapy, those outside the specified age range, and those unable to follow study procedures are excluded. Additionally, patients with serious health conditions that might interfere with the study, those who are pregnant or breastfeeding, those participating in another clinical trial simultaneously, those with a history of allergic reactions to similar medications, and those with certain immune system disorders are not eligible.
Focus and goal: The study evaluates whether durvalumab improves disease-free survival when given after standard trimodality therapy. Participants are randomly assigned to receive either durvalumab or no additional treatment (surveillance only). The trial monitors the prevention of cancer return, control of cancer in the bladder area, overall survival rates, and quality of life. The study is expected to conclude by January 2026.
Investigational drug: Durvalumab is an immunotherapy medication that helps the body’s immune system recognize and attack cancer cells. It works by blocking a protein called PD-L1, which enhances the body’s natural defenses to fight cancer. Durvalumab is classified as an immune checkpoint inhibitor.
Summary
There are currently 2 clinical trials available for patients with Bladder Transitional Cell Carcinoma Stage III. Both studies focus on immunotherapy approaches using immune checkpoint inhibitors that target the PD-L1 protein pathway.
The first trial is available across multiple European countries including Austria, Czechia, France, Hungary, Poland, and Spain, offering continued access to atezolizumab for patients who previously participated in related studies. Spain is the only country hosting both trials.
Both studies investigate similar classes of medications—atezolizumab and durvalumab—which work through comparable mechanisms to help the immune system fight cancer cells. The first study focuses on long-term continuation therapy for patients already benefiting from treatment, while the second specifically addresses muscle-invasive bladder cancer following standard trimodality therapy.
Patients interested in these trials should discuss eligibility criteria with their healthcare providers, particularly regarding prior treatment history, disease stage, and ability to meet the specific requirements of each study.
