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Combined Immunotherapy and Chemotherapy for Muscle-invasive Bladder Cancer

Trial ID:
IRB-19-7391
Munveer S Bhangoo, MD
This study will test the effectiveness of Pembrolizumab (KEYTRUDA) given before and after surgery for the
treatment of muscle-invasive bladder cancer. Pembrolizumab is used as an immune-enhancing medication, that may block immune pathways for tumor growth.

Inclusion Criteria

Patients must:
  • Be 18 years of age or older
  • Have a confirmed diagnosis of Muscle – invasive Bladder Cancer (MIBC), Clinical Stage T2-T4aN0M0
  • Be eligible to receive cisplatin chemotherapy.
  • Be eligible for surgical treatment and agree to planned surgical treatment

Exclusion Criteria

Patients must not:
  • Have received any prior systemic anti-cancer treatment for MIBC
  • Be pregnant or breastfeeding or expecting to conceive or father children within the defined study duration
  • Have a known history of HIV, Hepatitis B, or active Hepatitis C

Additional Info

  • All patients will receive chemotherapy (cisplatin + gemcitabine) and surgery, and will be randomly selected
  • to receive either pembrolizumab or placebo.
  • All treatments and physician visits during this study will take place at Scripps Clinic Torrey Pines. Study
  • treatment will occur for approximately 1 year and patients will be followed for up to 5 years after treatment has ended.
  • For more information, search for NCT03924856 at www.clinicaltrials.gov

Contact Info:

  • Clinical Research Services
  • CRSLeadership@scrippshealth.org