Last updated on July 2019

Neoadjuvant GMCI Plus Chemoradiation for Advanced Non-Metastatic Pancreatic Adenocarcinoma

Brief description of study

The purpose of this study is to evaluate Gene Mediated Cytotoxic Immunotherapy (GMCI) in combination with standard of care chemoradiation and surgery for borderline resectable and unresectable locally advanced pancreatic cancer in patients who have completed induction chemotherapy. GMCI kills tumor cells and creates an immune stimulatory environment in the tumor. Killing tumor cells in an immune stimulatory environment induces the body's immune system to detect and destroy cancer cells. GMCI has shown synergy with radiation and surgery without added toxicity. The hypothesis is that GMCI added to standard of care chemoradiation and surgery after completion of induction chemotherapy will be safe and will improve the clinical outcome for patients with pancreatic cancer.

Detailed Study Description

GMCI involves the injection of aglatimagene besadenovec (AdV-tk) into the tumor followed by oral valacyclovir pills to kill tumor cells and stimulate a cancer vaccine effect. The current protocol is designed to deliver multiple courses of GMCI in combination with standard of care chemoradiation and surgery to capitalize on the synergies with the different treatment modalities.

This protocol includes two phases:

  • Phase 1b - completed.
  • The Phase 2 is a randomized study comparing a test group receiving GMCI added to chemoradiation and surgery to a control arm receiving chemoradiation followed by surgery. Participants will be randomized in a 1:1 ratio to GMCI plus standard of care or standard of care alone. Both arms receive standard of care treatment and evaluations.

Clinical Study Identifier: NCT02446093

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