Immunotherapy + Radiation for Bladder Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new approach to treating muscle invasive bladder cancer. After initial chemotherapy, it combines immunotherapy (which helps the immune system fight cancer) with radiation therapy to determine if it can prevent bladder removal surgery. The trial seeks participants with muscle invasive bladder cancer who have completed chemotherapy. Participants should have urothelial carcinoma and should not have received certain previous cancer treatments. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in cancer treatment.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, you cannot be on immunosuppressive medications or steroids over 10 mg/day of prednisone (or equivalent) at the time of registration.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies have shown pembrolizumab to be relatively safe, with fewer side effects compared to some other treatments. For instance, one study found that pembrolizumab caused fewer problems than chemotherapy, with many side effects being mild and manageable.
Research has shown that photon beam radiation therapy is generally safe and effective, with most people tolerating it well. This type of radiation targets cancer cells while sparing healthy tissues, potentially leading to fewer side effects.
Since this trial is in Phase 2, earlier phases have already provided some evidence of safety in humans. However, researchers are still studying it to gather more safety information when used with pembrolizumab. It is important to consult a doctor to understand the risks and benefits before joining a trial.12345Why are researchers excited about this trial's treatments?
Researchers are excited about combining pembrolizumab with photon beam radiation therapy for bladder cancer because it offers a unique approach compared to traditional treatments like surgery, chemotherapy, or standard radiation. Pembrolizumab is an immunotherapy drug that boosts the body's immune system to detect and attack cancer cells more effectively. Photon beam radiation precisely targets tumors, which may reduce damage to surrounding healthy tissue. This combination could enhance the effectiveness of treatment by simultaneously attacking cancer on two fronts, potentially leading to better outcomes for patients with fewer side effects.
What evidence suggests that this combination of pembrolizumab and radiation therapy might be an effective treatment for muscle invasive bladder cancer?
Research has shown that pembrolizumab, a type of immune therapy, effectively treats bladder cancer. Studies found that about 61% of patients who received pembrolizumab survived for three years, a significant improvement over other treatments. Photon beam radiation therapy has also yielded positive results. In one study, about 90% of patients retained their bladder long-term, offering hope for those wishing to avoid surgery. This trial will evaluate the combination of pembrolizumab with photon beam radiation therapy, which might enhance these benefits.12346
Who Is on the Research Team?
Leslie Ballas
Principal Investigator
SWOG Cancer Research Network
Are You a Good Fit for This Trial?
This trial is for patients with muscle invasive bladder cancer who've had chemotherapy to shrink the tumor and are now seeking to avoid bladder removal. They must have undergone specific diagnostic procedures recently, show no evidence of advanced disease, and not have certain types of aggressive or variant cancers or a history of urothelial carcinoma outside the bladder within 24 months.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Neoadjuvant Therapy
Participants receive standard of care chemotherapy to shrink or eliminate the tumor before the main treatment
Treatment
Participants undergo photon beam radiation therapy and receive pembrolizumab intravenously every 21 days for up to 18 cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment completion
What Are the Treatments Tested in This Trial?
Interventions
- Pembrolizumab
- Photon Beam Radiation Therapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor