Baltimore, Maryland 21231


Purpose:

This study will be looking at whether CY/GVAX with nivolumab is more effective than CY/GVAX alone in altering the pancreatic tumor microenvironment (IL17 expression) to aid in the anti-tumor response.


Study summary:

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, the investigators 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. The investigators 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. The investigators 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 the investigators with the opportunity to better understand how these immune cells traffic into the tumor and function once they arrive. The investigators 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, the investigators will test the effects of blocking PD-1 in combination with the vaccine in patients with pancreatic cancer. The investigators will specifically isolate these immune cells and evaluate at both the genetic and protein level, the types of signals expressed by these aggregates. The investigators will compare aggregates from patients with long term survival versus patients who succumb to their cancer early. In this way, the investigators 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.


Criteria:

Inclusion Criteria: 1. Newly diagnosed adenocarcinoma of the head, neck, or uncinate process of the pancreas - Stage I or II disease 2. Surgically resectable disease (R0 or R1) by spiral CT scan - No distant metastases 3. ECOG Performance Status of 0 to 1 4. Adequate organ function as defined by study-specified laboratory tests 5. Must use acceptable form of birth control 6. Signed informed consent form 7. Willing and able to comply with study procedures Exclusion Criteria: 1. Currently have or have history of certain study-specified heart, liver, kidney, lung, neurological, immune, psychological or other medical conditions 2. Patients with history of any autoimmune disease:inflammatory bowel disease, (including ulcerative colitis and Crohn's Disease), rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythematosus (SLE) autoimmune vasculitis (e.g., Wegener's Granulomatosis), CNS or motor neuropathy considered to be of autoimmune origin (e.g., Guillian-Barre Syndrome, Myasthenia Gravis, Multiple Sclerosis) 3. Patients who have been diagnosed with another cancer in the past 5 years (except for superficial bladder cancer, non-melanoma skin cancers, or a low grade prostate cancer not requiring therapy) 4. Patients who have received therapy for pancreatic cancer 5. Using systemically active steroid use 6. Patients who have known history of infection with HIV, hepatitis B, or hepatitis C 7. Patients on home oxygen 8. Patients with oxygen saturation of <92% on room air by pulse oximetry 9. Pregnant or lactating 10. Conditions, including alcohol or drug dependence, or intercurrent illness that would affect the patient's ability to comply with study visits and procedures


NCT ID:

NCT02451982


Primary Contact:

Principal Investigator
Lei Zheng, MD, PhD
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University

Carol Judkins, RN
Phone: 410-614-5241
Email: judkica@jhmi.edu


Backup Contact:

N/A


Location Contact:

Baltimore, Maryland 21231
United States

Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Ce
Phone: 410-955-8804
Email: jhcccro@jhmi.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 17, 2017

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