Learn more about a new clinical trial for people who need or want options other than bladder removal surgery
For people with muscle‑invasive bladder cancer, the most common standard treatment is surgery to remove all or most of the bladder. This is a life-altering treatment that does not always prevent the cancer from returning. Alternative radiation and chemotherapy treatments that aim to spare the bladder do not work for everyone and can have significant side effects. New options are needed for patients who cannot have or prefer to avoid bladder removal.
This clinical trial will help us understand whether a combination of 2 study drugs, compared with a standard combination of radiation and chemotherapy, is safe to use and can help people with muscle-invasive bladder cancer. There is no placebo (inactive treatment) used in this trial.
Who may participate
You might be able to take part in this study if you are 18 years of age or older and meet certain study requirements, including:
- Have been diagnosed with muscle-invasive bladder cancer
- Have not been treated with radiation or chemotherapy (certain chemotherapies which were delivered directly into the bladder may be allowed)
- Are ineligible for or have chosen not to have part or all of the bladder removed
Condition
Muscle-invasive bladder cancer
Age
18+ years
Sex
Male or Female
Each clinical study has its own guidelines for who can participate, called eligibility criteria. However, only the research study staff can determine if you qualify to enroll in the study.
What to expect
If this clinical trial is a good fit for you and you decide you want to take part, you will be assigned randomly (by chance, like tossing a coin) to receive either the study drugs (Arm A) or a standard combination of radiation and chemotherapy (Arm B).
Arm A:
If you are assigned to receive the study drugs you will receive treatment for about 1 year. The study drugs are given as an intravenous or “IV” infusion (through a needle inserted into the vein). You will have infusions at clinic visits, which will happen twice every 3 weeks for about 6 months, then once every 3 weeks for about 6 months. Some visits may include more than one infusion on the same day.
Arm B:
If you are assigned to receive radiation and chemotherapy, the study doctors will spend up to 8 weeks planning your treatment. You will then receive radiation and chemotherapy treatment for about 4 to 6.5 weeks. You will receive radiation treatment 5 days every week on Monday through Friday. You may have 1-2 extra visits every week to receive an intravenous “IV” infusion of chemotherapy, depending on which treatment your doctor thinks is best for you. You may need additional visits depending on your treatment plan.
In both groups, patients will continue having follow up visits or phone calls every 12 weeks after finishing the study treatment.
Length of study treatment
Arm A: About 1 year/Arm B: 4 to 6.5 weeks
Number of study visits
Arm A: 1-2 every 3 weeks/Arm B: 4-7 visits + 5 days per week of radiotherapy
Long-term follow up
Every 12 weeks
Tomorrow’s breakthroughs start today with you
Representation in study participants is important in order to understand how potential medicines work in different people. Race, ethnicity, age, and sex can all impact how different people respond to the same treatment.
When you participate in a study, you’re helping to represent both your community and all people who are affected by bladder cancer. Your participation could make a difference.
Frequently asked questions
One of the study drugs is designed to deliver a targeted chemotherapy directly to the cancer cells, while the other is designed to activate the body’s immune system against the cancer cells and slow down tumor growth.
You can speak to the study doctor to learn more.
There is no placebo (inactive treatment) used in this clinical trial.
The study drugs, and all assessments that are not a part of your regular medical care, will be provided at no cost. You may also have some trial-related costs paid back, like travel and accommodation.
You can speak with the study team to find out more about costs and reimbursement.
There are no guaranteed benefits to joining a clinical trial. You will have regular visits to the study site and your health and cancer will be closely monitored for the duration of the clinical trial. Participating in clinical trials helps researchers learn more about the disease and advance potential treatment options.
Participant safety is the top priority of this clinical trial. It is possible your condition or health may improve, worsen, or stay the same. Your trial doctor will discuss all the possible risks and benefits of participating with you before you choose to enroll.
