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