Ipilimumab, Nivolumab, Tocilizumab and Radiation in Pretreated Patients With Advanced Pancreatic Cancer

This is a phase II study assessing ipilimumab, nivolumab and tocilizumab in combination with SBRT of 15 Gy in patients with locally advanced or metastatic PC whose disease has progressed on at least 1. line chemotherapy with either a 5-FU-containing and /or gemcitabine containing chemotherapy. The trial is designed as an investigator initiated prospective open-label study in patients with advanced PC to determine the efficacy and safety ipilimumab, nivolumab and tocilizumab in combination with SBRT. This study will consist of Part A, Lead-in, as well as a possible Part B, non-randomized expansion (Part B: Expansion) or a possible Part B, randomized controlled study (Part B: RCT). Initially, patients will be enrolled in the study to treatment with ipilimumab, nivolumab and tocilizumab in combination with SBRT, until 30 patients have been treated (Part A: Lead-in). Patient recruitment and tumor assessment will be monitored on an ongoing basis. This Part A: Lead-in involves Department of Oncology, Herlev and Gentofte Hospital, Copenhagen University Hospital, Denmark. Multicenter extension will be activated in case of successfully completed lead-in phase and the format of that Part B will be determined based on the responses seen in the first 30 patients in Part A. A protocol amendment will be made if criteria are met to proceed to Part B. The protocol amendment will include available data from Part A and any changes to study design, additional sites and statistical plan, if needed.