Personalized Vaccine With SOC Chemo Followed by Nivo in Pancreatic Cancer

Summary

Participation Requirements

Description

This is a single center, single arm, phase Ib trial to evaluate the feasibility, safety, immunogenicity, and efficacy of subcutaneous dendritic cell (DC) vaccine loaded with personalized peptides [PEP-DC vaccine] in combination with standard of care adjuvant chemotherapy (gemcitabine and capecitabin...

This is a single center, single arm, phase Ib trial to evaluate the feasibility, safety, immunogenicity, and efficacy of subcutaneous dendritic cell (DC) vaccine loaded with personalized peptides [PEP-DC vaccine] in combination with standard of care adjuvant chemotherapy (gemcitabine and capecitabine), followed by the antibody nivolumab in patients with non-metastatic surgically resected pancreatic adenocarcinoma. All patients will have previously undergone collection of resected advanced pancreatic tumor tissue under a different research protocol with a separate informed consent. After registration, all patients will receive standard of care chemotherapy consisting of intravenous gemcitabine, and oral capecitabine for eight 21-day cycles. Additionally, all eligible patients will undergo apheresis during the last week of cycle 3 of standard of care chemotherapy to collect peripheral blood mononuclear cells (PBMCs) for dendritic cell vaccine production. All patients will receive at least six PEP-DC vaccinations starting concomitant with the 5th cycle of chemotherapy. Vaccine will be administered subcutaneously every 3 weeks, on day 9 (the day after last gemcitabine infusion) of each 21-day cycle, and thereafter every four weeks starting from the second nivolumab administration. Nivolumab intravenous administration will start three weeks after the last cycle of chemotherapy and will be given as a flat dose every 2 weeks during the vaccination period until the last vaccine dose or at least 8 weeks after the end of the last chemotherapy cycle if vaccination stops earlier. Regular physical examination, radiological evaluation and blood testing for safety parameters will be performed according to the schedule during treatment.

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