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Completed

NCT Number: NCT03161379

GVAX Pancreas Vaccine (With CY) in Combination With Nivolumab and SBRT for Patients With Borderline Resectable Pancreatic Cancer

The purpose of this study is to evaluate the safety and clinical activity of FOLFIRINOX along with a whole cell vaccine with immune modulating doses of cyclophosphamide and nivolumab combined with Stereotactic Body Radiation Therapy (SBRT) in patients with pancreatic cancer.

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Key information

Conditions

Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Have histologically proven pancreatic cancer that is borderline resectable
  • No more than 1 month/cycle (28 days) of systemic therapy for pancreatic cancer
  • Age >18 years old.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  • Patients must have adequate organ and marrow function defined by study-specified laboratory tests.
  • Woman of child bearing potential must have a negative pregnancy test.
  • Must use an acceptable form of birth control while on study.
  • Must be candidate for Stereotactic Body Radiation Therapy (SBRT)
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion criteria

  • Had major surgery within the last 28 days
  • Had an investigational drug or device within the past 28 days
  • Prior treatment with immunotherapy agents (including, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4, etc)
  • Completed more than 1 month/cycle (28 days) of chemotherapy for pancreas cancer
  • Patient on an immunosuppressive systemic treatment, such as steroids, in the past 2 years.
  • Other cancer diagnosis requiring treatment within two years
  • History of allergic reactions related to the drugs (Nivolumab, Cyclophosphamide, GM-hetastarch, corn, dimethyl sulfoxide, fetal bovine serum, trypsin (porcine origin), yeast or any other component of the GVAX vaccine) in this study.
  • Patients receiving growth factors within the last 14 days.
  • Currently have or have history of certain study-specified heart, liver, kidney, lung, neurological, psychological, immune or other medical conditions.
  • Pregnant or breastfeeding.
  • Have known history of infection with HIV, hepatitis B, or hepatitis C.
  • Unwilling or unable to follow the study schedule for any reason.
  • Presence of tissue or organ allograft, regardless of need for immunosuppression (including corneal allograft)
  • Squamous pancreatic cancer or adenosquamous pancreatic cancer with malignant squamous cells >30%

Treatment and study plan

Cyclophosphamide

Drug

Cyclophosphamide 200 mg/m2 will be administered one day prior to vaccination (day 0). First dose will be given within 4 to 6 weeks after chemotherapy. 3 weeks after the first dose of immunotherapy the second dose will be given.

Other names: CY

Nivolumab

Drug

Nivolumab (240 mg) will be administered one day prior to vaccination. First dose will be given within 4 to 6 weeks after chemotherapy. 3 weeks after the first dose of immunotherapy the second dose will be given.

Other names: OPDIVO

GVAX Pancreas Vaccine

Drug

Vaccine will be administered one day after cyclophosphamide and nivolumab. 3 weeks after the first dose of immunotherapy the second dose will be given.

Other names: PANC 10.05 pcDNA-1/GM-Neo and PANC 6.03 pcDNA-1/GM-Neo vaccine

Stereotactic Body Radiation (SBRT)

Radiation

SBRT (6.6 Gy over 5 days) will be started during the second dose of immunotherapy (3 weeks after the first dose of immunotherapy).

Primary outcomes

  1. CD8+ T Cell Density in Tumor Tissue

    Time frame: evaluated at time of surgery, approximately 2 months from first dose of study drug

    Mean CD8+ T cell density [log(cells per mm^2)], found in resected surgical tissue by Immunohistochemistry (IHC).

Secondary outcomes

  1. Pathologic Complete Response (pCR) Rate at Surgical Resection

    Time frame: Assessed at time of surgical resection, approximately 2 months after first dose of study drug

    Number of patients with a pathologic complete response (pCR) rate at surgical resection. A pCR is defined as no viable residual tumor remaining at the time of evaluation.

Sponsors and collaborators

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Other

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study title

A Phase II Clinical Trial of GVAX Pancreas Vaccine (With Cyclophosphamide) in Combination With Nivolumab and Stereotactic Body Radiation Therapy (SBRT) Followed by Definitive Resection for Patients With Borderline Resectable Pancreatic Adenocarcinoma

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
May 19, 2017
Registry last updated
Feb 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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