Fig. 1: J1568 study treatment schema.

Eligible patients with clinically resectable PDA received the first priming study treatment Cy-GVAX-based therapy (alone [Arm A], + PD-1 [Arm B], + PD-1 and CD137 [Arm C]) 2 weeks before the surgical resection, and the 2nd priming treatment 6–10 weeks following definitive surgical resection. Patients began SOC adjuvant therapy ~4 weeks following the 2nd study treatment. SOC adjuvant chemotherapy was administered as per the standard of care at the time at the discretion of the primary treatment oncologist. The 3rd (and up to 6th) priming study treatment was administered every 28 days beginning four weeks after the completion of SOC adjuvant therapy. Study treatment was given as follows: Day 1–Cyclophosphamide (Cy) 200 mg/m² IV (Arms A, B, C), nivolumab (PD-1) initially, 3 mg/kg, and later 480 mg IV following approval of every 4 week flat dose (Arms B, C), urelumab (CD137) 8 mg IV (Arm C Only); Day 2–GVAX intradermal (Arms A, B, C) was injected equally into six intradermal areas in both lower limbs and the non-dominant upper limb. This study began randomized enrollment to Arms A and B in March 2016. In October 2018, the study protocol was amended to add Arm C (due to limited supply of urelumab, Arm C had to enroll consecutively) as well as an optional “extended-treatment” phase. In this “extended-treatment” phase, all patients with no evidence of recurrence following the initial six priming doses of study treatment were given the option to receive additional Cy-GVAX every 12 weeks (up to 2 additional treatments), and, for Arm B and Arm C participants only, nivolumab (without ureulmab) every 4 weeks (up to six additional treatments).