Durvalumab + BCG for Bladder Cancer
(POTOMAC Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing a new treatment that combines two therapies to help the immune system fight bladder cancer. It targets patients whose cancer has not spread into the muscle layer of the bladder. The treatment works by helping the body's defense system recognize and destroy cancer cells more effectively.
Do I need to stop my current medications for the trial?
The trial does not specify if you need to stop your current medications, but you cannot use immunosuppressive medications within 14 days before starting the trial. Hormonal therapy for non-cancer conditions is allowed.
What safety data exists for Durvalumab + BCG treatment in humans?
BCG treatment for bladder cancer can cause side effects, which vary depending on the strain and dose used. Common side effects include bladder irritation and flu-like symptoms. There is no specific safety data for the combination of Durvalumab and BCG, but BCG alone has been studied extensively for bladder cancer.12345
What makes the Durvalumab + BCG treatment for bladder cancer unique?
What data supports the effectiveness of the drug Durvalumab + BCG for bladder cancer?
Research shows that Durvalumab, a drug that helps the immune system fight cancer, has been approved for treating certain types of bladder cancer. Additionally, BCG is a well-established treatment for bladder cancer, and combining it with immune therapies like Durvalumab may enhance its effectiveness.56789
Are You a Good Fit for This Trial?
This trial is for adults with high-risk non-muscle-invasive bladder cancer who haven't had immune therapy or BCG for bladder cancer, and no recent immunosuppressants. It's not for those with muscle-invasive or advanced cancer, certain autoimmune diseases, or a history of other cancers (with some exceptions).Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Durvalumab + BCG combination therapy or BCG alone as standard of care
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Bacillus Calmette-Guerin (BCG)
- Durvalumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
AstraZeneca
Lead Sponsor
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology