Durvalumab for Bladder Cancer
Trial Summary
What is the purpose of this trial?
The purpose of this study is to find out what effects durvalumab has on bladder cancer, combined with treatment after completion of surgery, chemotherapy and radiotherapy.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot use immunosuppressive medications within 28 days of starting the study, except for certain corticosteroids at low doses. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the drug Durvalumab for bladder cancer?
Durvalumab has shown meaningful clinical activity in patients with metastatic urothelial carcinoma, a type of bladder cancer, in clinical studies. It has been approved by the FDA for patients whose cancer has progressed after chemotherapy, indicating its effectiveness in treating this condition.12345
Is durvalumab safe for human use?
Durvalumab has been studied for safety in various cancers, including bladder cancer. Common side effects include reduced appetite and diarrhea, with serious side effects occurring in about 24% of patients when used alone. Safety data from multiple studies suggest it is generally safe, but side effects can vary.12367
How is the drug durvalumab unique for treating bladder cancer?
Durvalumab is unique because it is a monoclonal antibody that blocks PD-L1, enhancing the body's immune response against cancer cells. It is specifically approved for patients with advanced bladder cancer who have not responded to platinum-based chemotherapy, offering a new option for those with limited treatment choices.12389
Research Team
Wassim Kassouf
Principal Investigator
The Research Institute of the McGill University, Montreal QC Canada
Eligibility Criteria
Adults over 18 with muscle-invasive bladder cancer, who've completed surgery, chemo, and radiotherapy can join this trial. They should have no metastatic disease, a life expectancy over 6 months, good organ function, and be within certain weight and health status limits. Women/men of childbearing potential must agree to use effective contraception for 3 months post-treatment.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Initial Treatment
Participants undergo surgery, chemotherapy, and radiotherapy for muscle-invasive bladder cancer
Adjuvant Treatment
Participants receive durvalumab to assess its effects on bladder cancer post initial treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Durvalumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Canadian Cancer Trials Group
Lead Sponsor
AstraZeneca
Industry 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