Clinical Study Protocol HCRN GI16-263 Protocol Title A phase II multi-center study evaluating combination immunotherapy for advanced cholangiocarcinoma with pembrolizumab and Sylatron (peginterferon alfa-2b) Sponsor Investigator Aiwu Ruth He, MD, PhD Lombardi Comprehensive Cancer Center Georgetown University 3800 Reservoir Road, NW Washington DC, 20007 Tel: 202-444-8642 Fax:202-444-9429
[email protected] Co-Investigators Iyer Renuka MD Davendra P. S. Sohal, MD, MPH Roswell Park Cancer Institute Cleveland Clinic Clinical Genomics Program 646 Main St, Buffalo, NY 14202 Taussig Cancer Institute Telephone (716) 845-2300 9500 Euclid Avenue, R35
[email protected] Cleveland, OH - 44195 Telephone: (216) 444-8258
[email protected] Statistician Hongkun Wang, PhD 4000 Reservoir Road, NW Washington DC, 20057 202-687-4146
[email protected] Trial Management Provided by Hoosier Cancer Research Network, Inc. 500 N. Meridian, Suite 100 Indianapolis, IN 46204 Trial Supported by: Merck Sharp and Dohme Corp. (“Merck”) Investigational New Drug (IND) # 129815 Initial Protocol Version Date: 12/9/15 Protocol Amendment Version Date: 30DEC2016 15DEC2017 10FEB2017 11APR2017 07JUN2017 19SEP2017 Clinical Study Protocol HCRN GI16-263 PROTOCOL SIGNATURE PAGE A phase II multi-center study evaluating combination immunotherapy for advanced cholangiocarcinoma with pembrolizumab and Sylatron (peginterferon alfa-2b) VERSION DATE: 15DEC2017 I confirm I have read this protocol, I understand it, and I will work according to this protocol and to the ethical principles stated in the latest version of the Declaration of Helsinki, the applicable guidelines for good clinical practices, whichever provides the greater protection of the individual. I will accept the monitor’s overseeing of the study.