Clinical Trial Summary (S2427)
Combining Immunotherapy and Radiation Therapy to Help Patients Avoid Bladder Removal after Treatment Shrinks Muscle Invasive Bladder Cancer (BRIGHT Trial)
What is the purpose of this clinical trial?
People in this trial have muscle invasive bladder cancer — and the cancer has shrunk or can’t be found after treatment with chemotherapy, immunotherapy, targeted drugs, or a combination of these. The study asks if these patients can avoid having their bladder removed if they receive an immunotherapy drug called pembrolizumab along with radiation therapy.
Immunotherapy is a type of treatment that helps the immune system fight cancer. Radiation therapy uses energy from X-rays to kill cancer cells.
This trial is set up to find out:
- If combining pembrolizumab and radiation therapy can help keep the cancer from coming back or getting worse
- If this combination can prevent the need for bladder removal surgery
Why is this trial important?
Many people with muscle invasive bladder cancer have their bladder removed as part of their treatment. Bladder removal surgery can have a big impact on quality of life — for example, it changes the way people pee and can affect sexual health.
This trial will help researchers find out if it’s possible to prevent the need for bladder removal
surgery so patients can have better quality of life.
Who can be in this trial?
This trial is for adults age 18 or older who were treated for muscle invasive bladder cancer.
This trial may be for people who:
- Received chemotherapy, immunotherapy, targeted drugs, or a combination of these and then had a surgery called transurethral resection of bladder tumor (TURBT)
- Had a tumor that shrunk or can’t be found after earlier treatment and TURBT
This trial is not for people who:
- Already received radiation therapy
- Received certain immunotherapy or targeted drugs
- Need to take steroids (like prednisone) to control the body’s immune system responses
- Are pregnant or breastfeeding
Talk with your doctor to learn more about who can join the study.
What treatments will I get?
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You’ll get pembrolizumab once every 3 weeks for a year. You’ll get the drug through an IV (a needle placed into a vein in your arm). Pembrolizumab (Keytruda) is approved by the Food and Drug Administration (FDA) to treat bladder cancer. You’ll also get radiation therapy treatment once a day, Monday through Friday (except on holidays) for about 1 month. You’ll get a total of 20 radiation therapy treatments. |
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How long will I be in the trial?
You’ll be in the study for 5 years total. You’ll receive treatment during the first year. After that, you’ll continue to have visits with your study doctor so they can see how you’re feeling and if the cancer comes back or gets worse.
Are there costs? Will I get paid?
You won’t need to pay for the pembrolizumab you get during the study. To learn more about what costs will and won’t be covered, talk to your health care provider and insurance provider.
You won’t be paid for joining the study.
Where can I find more information about this trial?
- Talk with your health care provider
- Call the National Cancer Institute at 1-800-4-CANCER
- Go to www.ClinicalTrials.gov and search the national clinical trial number: NCT07061964
- For a list of trial locations, visit swog.org/NCI-S2427
Key Information
Information your doctor or trial navigator may need to help you.
Protocol Number
S2427
NCT Number
NCT07061964
Full Trial Title
Single Arm Phase II Study of Bladder Preservation with Immunoradiotherapy after a Clinically Meaningful Response to Neoadjuvant Therapy in Patients with Muscle Invasive Bladder Cancer (BRIGHT)
Trial Sponsors
SWOG Cancer Research Network
Publication Date