Cover Page for Protocol – J1790 NCT Number: NCT0319026 5 Official title of study A Randomized Phase 2 Study of the Safety, Efficacy, and Immune Response of CRS - 207, Nivolumab, and Ipilimumab with or without GVAX Pancreas Vaccine (with Cyclophosphamide) in Patients with Previously Treated Metastatic Pancreatic Adenocarcinoma Document Date: December 10 , 2020 TITLE: A Randomized Phase 2 Study of the Safety, Efficacy, and Immune Response of CRS - 207, Nivolumab, and Ipilimumab with or without GVAX Pancreas Vaccine (with Cyclophosphamide) in Patients with Previously Treated Metastatic Pancreatic Adenocarcinoma Johns Hopkins Protocol #: J1790 , IRB00137389 BMS Protocol #: CA209 - 9LM Principal Investigator: Dr. Dung Le (Protocol Chair ) IND Sponsor: Dr. Elizabeth Jaffee IND: BB IND 16147 Bristol - Myers Squibb Supplied Agent : Nivolumab (BMS - 936558; anti - PD - 1 mAb) Ipilimumab (BMS - 734016; anti - CTLA - 4 mAb) Johns Hopkins University Supplied Agent: GVAX pancreas vaccine (Panc 10.05 pcDNA - 1/GM - Neo, Panc 6.03 pcDNA - 1/GM - Neo) ; CRS - 207 ( Lm Δ actA /Δ inlB /hMesothelin) Commercial Agent: Cyclophosphamide (CY, Cytoxan ® ) Date of Issue : Version 1/ May 9 , 2017 Version 1.1/ June 30, 2017 Version 2.0/ November 17, 2017 Version 3.0/ June 1 , 2018 Version 4.0/ January 11, 2019 Version 5.0/ June 28, 2019 Version 6.0/ July 1 , 2020 Version 7.0/ December 10, 2020 J1790 / Version 7.0 / December 10, 2020 2 TABLE OF CONTENTS 1. OBJECTIVES ................................