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Report for Clinical Trial NCT03592888

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Pilot Study of Mature Dendritic Cell Vaccination Against Mutated KRAS in Patients With Resectable Pancreatic Cancer

This research study is designed to evaluate the effects of a dendritic cell (kind of white blood cell) vaccine for pancreatic cancer.

NCT03592888 Pancreatic Ductal Adenocarcinoma
MeSH:Adenocarcinoma

1 Interventions

Name: mDC3/8-KRAS Vaccine

Description: Mature dendritic cell (mDC3/8) vaccine (primer and booster) in subjects with resected pancreatic adenocarcinoma
Type: Drug
Group Labels: 1

All subjects


Primary Outcomes

Measure: Safety and side effects of vaccine per CTCAE 4.0

Time: At time of consent through 30 days after the subject's last DC vaccine

Secondary Outcomes

Measure: Immune response measuring increased numbers of peptide specific T cells as calculated by the peptide-MHC multimer assay.

Time: Day 1 through week 12

Measure: Disease Free Survival

Time: 30 days following second vaccine through study completion approximately 12 months after the first DC vaccine

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There are 4 SNPs

SNPs


1 G12C

Inclusion Criteria: - Pathologically-confirmed KRAS(G12D-), KRAS(G12V-), KRAS(G12R-) or KRAS(G12C-mutated) pancreatic ductal adenocarcinoma who are at high risk of relapse and have no evidence of disease. --- G12D --- --- G12V --- --- G12R --- --- G12C ---


2 G12D

Inclusion Criteria: - Pathologically-confirmed KRAS(G12D-), KRAS(G12V-), KRAS(G12R-) or KRAS(G12C-mutated) pancreatic ductal adenocarcinoma who are at high risk of relapse and have no evidence of disease. --- G12D ---


3 G12R

Inclusion Criteria: - Pathologically-confirmed KRAS(G12D-), KRAS(G12V-), KRAS(G12R-) or KRAS(G12C-mutated) pancreatic ductal adenocarcinoma who are at high risk of relapse and have no evidence of disease. --- G12D --- --- G12V --- --- G12R ---


4 G12V

Inclusion Criteria: - Pathologically-confirmed KRAS(G12D-), KRAS(G12V-), KRAS(G12R-) or KRAS(G12C-mutated) pancreatic ductal adenocarcinoma who are at high risk of relapse and have no evidence of disease. --- G12D --- --- G12V ---



HPO Nodes