Abbreviated Title: mRNA-Based, Cancer Vaccine Version Date: January 23, 2019 1 Abbreviated Title: mRNA-Based, Cancer Vaccine CC Protocol Number: 18-C-0074 E IBC Number: RD-18-I-07 OSP Number: 1803-1739 NCT Number: NCT03480152 Version Date: January 23, 2019 PROTOCOL TITLE A Phase I/II Trial to Evaluate the Safety and Immunogenicity of a Messenger RNA (mRNA)- Based, Personalized Cancer Vaccine Against Neoantigens Expressed by the Autologous Cancer NIH Principal Investigator: Steven A. Rosenberg, M.D., Ph.D. Chief of Surgery, Surgery Branch, CCR, NCI Building 10, CRC, Room 3-3940 9000 Rockville Pike, Bethesda, MD 20892 Phone: 240-858-3080; E-ma il: Steven.Rosenberg@nih.gov Investigational Agent: Drug Name: NCI-4650 (mRNA-based, Personalized Cancer Vaccine) IND Number: 17858 Sponsor: Center for Cancer Research Manufacturer: ModernaTX, Inc. Abbreviated Title: mRNA-Based, Cancer Vaccine Version Date: January 23, 2019 2 PRÉCIS Background: x Therapeutic vaccination against cancer has proven very challenging with little clinical benefit.