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Immune Checkpoint Inhibitors With or Without Propranolol Hydrochloride In Patients With Urothelial Carcinoma

Testing immune drugs, with or without propranolol, for bladder cancer patients.

Recruiting
18 years and older
All
Phase 2

This study looks at treating urothelial carcinoma, a type of bladder cancer, using medicines called immune checkpoint inhibitors (ICI) with or without a drug named propranolol hydrochloride. Immune checkpoint inhibitors help the immune system fight cancer. Propranolol is usually used for heart conditions but might help cancer treatment too. The study is open label, meaning both doctors and patients know what treatment is being given.

The main goal is to check if using propranolol with ICIs is safe and to see how well it helps treat the cancer. Participants will be divided into two groups: one will receive ICIs with propranolol, and the other will receive ICIs alone. ICIs used are Pembrolizumab, Avelumab, and Nivolumab.

  • The study lasts up to 2 years with follow-up every 12 weeks.
  • Participants must be at least 18 years old and meet specific health criteria.
  • Safety and side effects will be closely monitored throughout the study.
Study details
    Locally Advanced Bladder Urothelial Carcinoma
    Locally Advanced Renal Pelvis Urothelial Carcinoma
    Locally Advanced Ureter Urothelial Carcinoma
    Locally Advanced Urethral Urothelial Carcinoma
    Locally Advanced Urothelial Carcinoma
    Metastatic Bladder Urothelial Carcinoma
    Metastatic Renal Pelvis Urothelial Carcinoma
    Metastatic Ureter Urothelial Carcinoma
    Metastatic Urethral Urothelial Carcinoma
    Metastatic Urothelial Carcinoma
    Stage IV Bladder Cancer AJCC v8
    Stage IV Renal Pelvis Cancer AJCC v8
    Stage IV Ureter Cancer AJCC v8
    Stage IV Urethral Cancer AJCC v8

NCT04848519

Emory University

13 December 2024

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