Swiss University Hospital is undertaking a phase Ib study of the combination of personalized Autologous Dendritic Cell Vaccine for Resected Pancreatic Adenocarcinoma
Photo by Serhat Beyazkaya
The Lausanne University Hospital (Centre Hospitalier Universitaire Vaudois) is starting a new clinical trial of Personalized Vaccine With SOC Chemo Followed by Nivo in Pancreatic Cancer.
Phase Ib clinical trial using Autologous Dendritic Cell Vaccine Loaded with Personalized Peptides (PEP) in order to stimulate/induce both innate and adaptive immunity by activating T-cells and Natural Killer (NK) cells, combined with standard of care (SOC) adjuvant chemotherapy, followed by nivolumab, an antibody against Programmed Cell Death 1 (PD-1), to maintain and boost the vaccine's effect in patients with non-metastatic resectable 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.
The clinical trial started in September 11, 2020 and will continue throughout September 2028.
Participants must meet the following criteria:
- Histologically confirmed resected adenocarcinoma of the pancreas .
- Mixed adenocarcinoma tumors are eligible provided the predominant invasive component of the tumor is adenocarcinoma.
- No distant metastasis.
- Appropriate amount of tumoral tissue was collected from the cytoreductive surgery and allowed the identification of top 10 personalized peptides (PEP) for preparation of PEP-DC vaccine.
- Eastern Cooperative Oncology Group (ECOG) performance status of 1 or 2.
- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol.
- Adequate hematologic and end-organ function, defined by the following laboratory results obtained within 21 days prior registration
and others.
The Lausanne University Hospital (Centre hospitalier universitaire vaudois, CHUV), in Lausanne, is one of the five university hospitals in Switzerland.
The Lausanne University Hospital is linked to the Faculty of Biology and Medicine of the University of Lausanne (UNIL).
The contacts and locations are the CHUV Oncology Department, Lausanne, Vaud, Switzerland, 1011. For more details: https://ichgcp.net/clinical-trials-registry/NCT04627246.
