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Combined Immunotherapy and Chemotherapy for Muscle-invasive Bladder Cancer

COVID-19 update:

In response to the COVID pandemic, Scripps Health has temporarily suspended enrollment for all clinical trials. Exceptions will exist for trials with curative intent, life-saving treatment or when no standard of care exists. For questions, please call Scripps Office for the Protection of Research Subjects at 858-678-6402.

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

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

Exclusion Criteria

  • 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

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