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

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03161379
Collaborator
Bristol-Myers Squibb (Industry)
30
Enrollment
2
Locations
1
Arm
58.9
Anticipated Duration (Months)
15
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Masking Description:
Open Label
Primary Purpose:
Treatment
Official 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
Actual Study Start Date :
Feb 2, 2018
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: CY, Nivolumab, GVAX, and SBRT

CY, Nivolumab, GVAX, and SBRT

Drug: Cyclophosphamide
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

    • Drug: Nivolumab
    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

    • Drug: GVAX Pancreas Vaccine
    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

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

    Outcome Measures

    Primary Outcome Measures

    1. CD8 count (cells/mm^3) in the tumor microenvironment [4 years]

      Whether the CD8 count in the tumor microenvironment is higher for patients with BR-PDAC treated with neoadjuvant chemotherapy, SBRT, and Cy/GVAX/nivolumab immunotherapy as compared to archived samples from patients treated with FOLFIRINOX and SBRT.

    Secondary Outcome Measures

    1. Pathologic complete response (pCR) rate at surgical resection [4 years]

      Pathologic complete response (pCR) rate at surgical resection of BR-PDAC treated with neoadjuvant sequential chemotherapy, SBRT, and Cy/GVAX/nivolumab immunotherapy.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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%

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore Maryland United States 21231
    2 Medical College of Wisconsin Milwaukee Wisconsin United States 53226

    Sponsors and Collaborators

    • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    • Bristol-Myers Squibb

    Investigators

    • Principal Investigator: Daniel Laheru, MD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    • Principal Investigator: Arsen Osipov, MD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    ClinicalTrials.gov Identifier:
    NCT03161379
    Other Study ID Numbers:
    • J1756
    • IRB00130075
    First Posted:
    May 19, 2017
    Last Update Posted:
    Mar 4, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    Neoadjuvant therapy
    immunotherapy
    Cytoxan
    Cyclophosphamide
    Pancreatic Vaccine
    SBRT
    GVAX
    Nivolumab
    borderline resectable
    Radioimmunotherapy
    Vaccine
    Antibody
    Anti-PD-1
    Additional relevant MeSH terms:
    Pancreatic Neoplasms
    Cyclophosphamide
    Nivolumab
    Pancrelipase
    Vaccines

    Study Results

    No Results Posted as of Mar 4, 2022