Neoadjuvant/Adjuvant GVAX Pancreas Vaccine (With CY) With or Without Nivolumab and Urelumab Trial for Surgically Resectable Pancreatic Cancer

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Brief Title

Neoadjuvant/Adjuvant GVAX Pancreas Vaccine (With CY) With or Without Nivolumab and Urelumab Trial for Surgically Resectable Pancreatic Cancer

Official Title

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

Brief Summary

      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.
    

Detailed Description

      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.
    

Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

Median IL17A expression in vaccine-induced lymphoid aggregates found in surgically resected pancreatic tumors

Secondary Outcome

 Number of participants experiencing immune-related toxicities (IRAEs)

Condition

Pancreatic Cancer

Intervention

Cyclophosphamide

Study Arms / Comparison Groups

 Arm A: CY/GVAX alone
Description:  Patients receive low-dose cyclophosphamide IV on day 0 and GVAX pancreatic cancer vaccine ID on day 1. Patients undergo pancreaticoduodenectomy on day 15. Approximately 6-10 weeks after surgery, patients receive low-dose cyclophosphamide IV on day 0 and the vaccine on day 1. Beginning approximately 1 month after vaccination, patients receive standard adjuvant chemoradiotherapy. Beginning approximately 4-8 weeks after the completion of chemoradiotherapy, patients receive low-dose cyclophosphamide IV on day 0 and the vaccine on day 1. Treatment with cyclophosphamide and the vaccine repeats every 28 days for 4 courses. Patients will then enter the extended treatment phase where they will receive cyclophosphamide on day 0, and GVAX on day 1 every 12 weeks for another 2 treatments.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

62

Start Date

February 2016

Completion Date

February 2023

Primary Completion Date

June 2022

Eligibility 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
      

Gender

All

Ages

18 Years - 100 Years

Accepts Healthy Volunteers

No

Contacts

Lei Zheng, MD, PhD, 410-614-5241, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02451982

Organization ID

J1568

Secondary IDs

IRB00050517

Responsible Party

Sponsor

Study Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

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


Verification Date

November 2019