For treatment of non-muscle invasive bladder cancer (NMIBC), the “go-to” therapy for decades has been Bacillus Calmette-Guerin (BCG), says Max Kates, M.D., Director of Urologic Oncology. But BCG is not perfect, he adds. “There have been problematic shortages as worldwide demand has increased,” resulting in rationing of the drug, “and for certain patients, adverse complications,” including a host of possible side effects including flulike symptoms, fatigue, and urinary tract infection.

Is there a better way to go? Kates believes there is: a combination of two chemotherapy drugs, gemcitabine and docetaxel (GEMDOCE). He is Principal Investigator of the BRIDGE trial (NCT05538663), a national phase III clinical trial he designed to compare both approaches in newly diagnosed, high-risk patients. In intravesical treatment, both drugs have been well-tolerated with few side effects – which include nausea and bladder spasms.

Both BCG and GEMDOCE are intravesical treatments, administered directly into the bladder. But they work in very different ways. BCG is a form of immunotherapy made from live bacteria – in fact, the same strain of bacteria used to create the tuberculosis vaccine. BCG stimulates the immune system to attack the cancer cells lining the bladder – as it would fight off a common cold. In contrast, gemcitabine acts against cancer cells by blocking them from making DNA, and its partner in GEMDOCE, docetaxel, stops cancer cells from growing and dividing. Both treatments can shrink NMIBC and prevent it from recurring.

This trial, the first of its kind in more than 30 years, has the capacity to change the way early bladder cancer is managed,” says Kates. “GEMDOCE offers a clear alternative that may be just as good as BCG.”

So far, more than 500 patients have been enrolled in the BRIDGE trial from more than 60 centers. “As part of this effort, we are also collecting urine, blood, and tissue samples,” says Kates. “Our goal is not only to demonstrate that intravesical GEMDOCE is equivalent to BCG, but also to develop genomic biomarkers that can predict which patients will respond best to which therapy.”