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Title:
J1568: A Randomized Study of a GM-CSF secreting allogeneic pancreatic cancer vaccine with or without a PD-1 Blockade Antibody (Nivolumab) and CD137 Agonist Antibody (Urelumab) for the Neoadjuvant and Adjuvant Treatment of Patients with Surgically Resectable Adenocarcinoma of the Pancreas
Protocol Number:
J1568
Phase:
Phase I/II
Physician:
Lei Zheng
Sites:
Johns Hopkins Kimmel Cancer Center in Baltimore
Purpose:
Eligibility:
Treatment:
Immunotherapy is an innovative approach being developed for the treatment of pancreatic cancer, a lethal and relatively chemotherapy-resistant disease. However, the tumor and its environment have developed a number of ways in which they inhibit the function of the immune system preventing it from recognizing and killing the cancer. In addition, we still do not understand how T cells, the cells in the immune system that have the potential to recognize cancer as different and kill cancer cells, traffic into the tumor to accomplish their task. We are currently testing an immune system activating pancreatic cancer vaccine (known as GVAX) in combination with immune boosting doses of the chemotherapy agent, cyclophosphamide, as preoperative and postoperative treatments for pancreatic cancer. We have discovered tertiary lymphoid aggregates, a unique lymph node-like structure formed within resected tumors from the patients who received the vaccine two weeks prior to the surgery. This discovery demonstrates that the immune system can get into the tumor and provides us with the opportunity to better understand how these immune cells traffic into the tumor and function once they arrive. We also found that the vaccine causes an increase in signals that would suppress the immune system’s ability to fight off cancer cells, including signals involving PD-1. In this novel study, we will test the effects of blocking PD-1 in combination with the vaccine in patients with pancreatic cancer. We will specifically isolate these immune cells and evaluate at both the genetic and protein level, the types of signals expressed by these aggregates. We will compare aggregates from patients with long term survival versus patients who succumb to their cancer early. In this way we will be able to determine how safe this novel treatment is, how effective it is at changing the immune system in pancreatic cancer, and how it impacts the health and survival of pancreatic cancer patients who undergo surgery to remove the cancer.
Population:
Adult
Last Update
03/05/2019 05:03 AM