We want to investigate whether immunotherapy (a therapy that influences your immune system) with the active substances BCG (a genetically modified vaccine) and atezolizumab, administered in combination with standard therapy, improves the prognosis in people with bladder cancer.
Aim of the study
Before a drug is used to treat a disease, it must be scientifically tested on study participants. We therefore want to investigate whether immunotherapy (a therapy that influences your immune system) with the active substances BCG (a genetically modified vaccine) and atezolizumab, administered in combination with standard therapy, improves the prognosis in people with bladder cancer.
Who can take part?
People who suffer from muscle-invasive bladder cancer and have a tumor that can be removed by surgery.
Procedure
If you fulfill the inclusion criteria and decide to participate in the study, you will receive immunotherapy with BCG and atezolizumab in addition to the standard treatment. The standard treatment consists of 4 cycles of chemotherapy (administered every 3 weeks) with cisplatin and gemcitabine followed by surgery on the tumor. Within the study, you will receive an additional 3 doses of BCG in the bladder (within 3 weeks) and 4 cycles of atezolizumab together with the standard chemotherapy.
Compensation
Original study name
Intravesical BCG followed by immuno-chemotherapy in patients with operable, muscle-invasive bladder cancer. A multicenter single-arm phase II study.
BASEC number
2021-01872
Sponsors