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UNC Bladder (LCCC 1520) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to look at how adding pembrolizumab to standard of care, cisplatin and gemcitabine, may work to shrink your tumor before surgery.

What is the Condition Being Studied?

Bladder Cancer

Who Can Participate in the Study?

Adult patients with muscle invasive bladder cancer who are planning to have a surgery to remove the bladder (cystectomy).

Age Group
Adults

What is Involved?

If you choose to join this study, you will:
- Enter a screening period that includes a physical exam, imaging scans, surveys, and blood draws

Once you have completed the screening period, you will:
- Get the study drug pembrolizumab on day 1 of each 3 week cycle along with standard-of-care gemcitabine and cisplatin on days 1 and 8.
-- You will take study drugs for 12 weeks (4 cycles)
- Have blood draws, a physical exam, and be asked questions about the side effects you might had while taking the study drug
- Get a cystectomy (bladder removal surgery) after you have taken the study drug
-- After your cystectomy, you will return to clinic for a post-surgery visit where you will be asked about your side effects.
--Be followed for up to 5 years after your post-surgery visit. Each visit may include surveys about your quality of life, and imaging.

Study Details

Full Title
Phase II Single Arm Study of Gemcitabine and Cisplatin plus Pembrolizumab as Neoadjuvant Therapy Prior to Radical Cystectomy in Patients with Muscle-Invasive Bladder Cancer
Principal Investigator
Medical Oncologist
Protocol Number
IRB:PRO00077902
NCT:NCT02690558
Phase
Phase II
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698