A Phase 2, Randomized, Open-Label, Controlled Study to Evaluate the Efficacy and Safety of Ampligen® Compared to Control Group / No Treatment Following FOLFIRINOX in Subjects with Locally Advanced Pancreatic Adenocarcinoma
Categories (click each to see list of all clinical trials associated with that category): GI (ONC)
Current Status: Open
Phase: II (Cancer Control)
Principal Investigator: Klute, Kelsey
Contact Information:
Jessica Delaney
jessdelaney@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT05494697?term=NCT05494697&rank=1
Summary
Primary Objective:
To compare the efficacy of Ampligen® versus Control group / no treatment following FOLFIRINOX in subjects with Locally Advanced Pancreatic Adenocarcinoma.
Secondary Objective:
To evaluate safety and tolerability of Ampligen® following FOLFIRINOX in subjects with Locally Advanced Pancreatic Adenocarcinoma.
Exploratory Objectives:
To explore Systemic Immune-Inflammation Index (SII) as a potential biomarker for overall survival.
To explore associations between subject reported symptoms, functioning and global health status/Quality of Life (QoL) using EORTC QLQ-C30 questionnaire as well as current health status and the EQ-5D Index used in the economic evaluation of health care using the EQ-5D-5L questionnaire.
Evaluation of lymphocyte profile by flow cytometry in patients with pancreatic cancer.
To evaluate levels of tumor marker CA19-9 in patients with pancreatic cancer.
To explore immune cell composition including B-cell and T-cell receptor diversity, blood biomarkers including circulating tumor DNA and antibodies against childhood immunogens, and T-cell responses to known childhood antigens such as MMR, which may predict and/or act as pharmacodynamic indicators of pharmacologic activity of Ampligen®.