NCT03956056

Neoantigen Peptide Vaccine Strategy in Pancreatic Cancer Patients Following Surgical Resection and Adjuvant Chemotherapy

A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of a Neoantigen Peptide Vaccine Strategy in Pancreatic Cancer Patients Following Surgical Resection and Adjuvant Chemotherapy

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 1 open-label study to evaluate the safety and immunogenicity of a neoantigen peptide vaccine strategy in pancreatic cancer patients following surgical resection and adjuvant chemotherapy. The neoantigen peptide vaccines will incorporate prioritized neoantigens and personalized mesothelin epitopes and will be co-administered with poly-ICLC. The hypothesis of this study is that neoantigen peptide vaccines will be safe and capable of generating measurable neoantigen-specific CD4 and CD8 T cell responses.

Conditions

• Pancreas Cancer
• Pancreatic Cancer
• Cancer of the Pancreas

Interventions

Type	Name	Description
BIOLOGICAL	Neoantigen Peptide Vaccine	• Each pool of vaccine study drug + poly IC:LC will be administered to one of the four limbs (A - Right Arm, B - Left Arm, C - Right Leg, D - Left Leg) by subcutaneous (SC) injection.
DRUG	Poly ICLC	• Each pool of vaccine study drug + poly IC:LC will be administered to one of the four limbs (A - Right Arm, B - Left Arm, C - Right Leg, D - Left Leg) by subcutaneous (SC) injection.
PROCEDURE	Blood for immune monitoring	-Baseline, day 1, day 22, day 50, day 78, week 25, and week 73

Timeline

• Start date: 2020-02-13
• Primary completion: 2022-07-21
• Completion: 2023-07-06
• First posted: 2019-05-20
• Last updated: 2024-07-17
• Results posted: 2023-05-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study