Pembrolizumab with Chemo in Urothelial and Prostate Cancers

Lay Title: Pembrolizumab with Chemo in Urothelial and Prostate Cancers
Technical Title: Phase Ib Trial of Pembrolizumab (MK-3475) with Platinum-based Chemotherapy in Small Cell/Neuroendocrine Cancers of Urothelium and Prostate 

Disease Type:Locally advanced or metastatic small cell/neuroendocrine cancers of the urothelium or prostate 

Basic information: This study is being done to see how the experimental drug, pembrolizumab (also called MK-3475), will work in conjunction with standard of care chemotherapy consisting of etoposide and cisplatin/carboplatin or docetaxel and carboplatin to help people with small cell carcinoma of the urothelial or prostate.

Research Procedures (not a complete list):
If you participate in this study, you will receive your standard chemotherapy every treatment cycle, which is 3 weeks long, for 4 to 6 weeks. You will also receive pembrolizumab every treatment cycle, and will continue pembrolizumab for up to 35 weeks. Pembrolizumab is given to you through an IV infusion.

After you begin treatment, you will return to the clinic every 3 weeks. During these visits, you will have a physical exam, blood draws, and urine sample collection. Extra blood may be collected during the visits for research purposes. 

You will continue to take pembrolizumab as long as our disease is not getting worse and you do not have bad side effects for up to 2 years. 

Eligibility Criteria (not a complete list):
Inclusion Criteria:

• Either (1) Locally advanced or metastatic naïve small cell cancer of the bladder, urethra, or upper urinary tract or (2) primary small cell or neuroendocrine prostate cancer
• No prior chemotherapy for your cancer, unless you recurred more than 12 months after completing chemotherapy.

Exclusion Criteria:

• No prior treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 treatments

For More Detailed Information, contact:

• Arnold Chin, MD, PhD, Principal Investigator, Associate Professor of Urology 
• Sara Rodriguez, Study Coordinator, (310) 794-2877

Read more about this study (NCT03711032) on ClinicalTrials.gov.