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Study With CY, Pembrolizumab, GVAX, and SBRT in Patients With Locally Advanced Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT02648282
Recruitment Status : Recruiting
First Posted : January 7, 2016
Last Update Posted : May 16, 2019
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Tracking Information
First Submitted Date  ICMJE January 5, 2016
First Posted Date  ICMJE January 7, 2016
Last Update Posted Date May 16, 2019
Actual Study Start Date  ICMJE July 12, 2016
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 6, 2016)
Distant Metastasis Free Survival (DMFS) [ Time Frame: 4 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02648282 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 6, 2016)
  • Overall Survival (OS) [ Time Frame: 4 years ]
  • Local Progression Free Survival (LPFS) [ Time Frame: 4 years ]
  • Number of participants experiencing immune-related toxicities (IRAEs) [ Time Frame: 4 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study With CY, Pembrolizumab, GVAX, and SBRT in Patients With Locally Advanced Pancreatic Cancer
Official Title  ICMJE A Phase II Study of GM-CSF Secreting Allogeneic Pancreatic Cancer Vaccine in Combination With PD-1 Blockade Antibody (Pembrolizumab) and Stereotactic Body Radiation Therapy (SBRT) for the Treatment of Patients With Locally Advanced Adenocarcinoma of the Pancreas
Brief Summary This study will be looking at whether combining cyclophosphamide, pembrolizumab (an antibody that blocks negative signals to T cells), GVAX (pancreatic cancer vaccine), and SBRT (focused radiation) is effective (anti-tumor activity) and safe in patients with locally advanced pancreatic cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pancreatic Cancer
Intervention  ICMJE
  • Drug: Cyclophosphamide
    200 mg/m2 is to be administered as a 30 minute IV infusion one day prior to GVAX for a total of 8 doses.
    Other Names:
    • Cytoxan
    • CY
  • Drug: GVAX
    2.5E8 cells of each cell line (Panc 6.03/Panc 10.05) for a total of 5E8 cells is to be administered one day after CY and pembrolizumab for a total of eight doses.
    Other Names:
    • Pancreatic cancer vaccine
    • Panc 10.05 pcDNA1/GM-Neo, Panc 6.03 pcDNA1/GM-Neo
  • Drug: Pembrolizumab
    200 mg will be administered as a 30 minute IV infusion one day prior to the GVAX pancreas vaccine for a total of 8 doses.
    Other Names:
    • MK-3475
    • KEYTRUDA
  • Radiation: SBRT
    Patients will receive SBRT (6.6 Gy for 5 days) with the second dose of combined immunotherapy (CY/Pembrolizumab/GVAX).
    Other Name: Stereotactic Body Radiation Therapy
Study Arms  ICMJE Experimental: Cyclophosphamide, Pembrolizumab, GVAX, SBRT
Interventions:
  • Drug: Cyclophosphamide
  • Drug: GVAX
  • Drug: Pembrolizumab
  • Radiation: SBRT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 6, 2016)
54
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2020
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. locally advanced pancreatic adenocarcinoma
  2. Patients must have received mFOLFIRINOX or Gemcitabine/ Abraxane based chemotherapy for 4 cycles with last dose of therapy between 2-5 weeks of study enrollment.
  3. No metastatic disease
  4. ECOG Performance Status of 0 to 1
  5. Adequate organ function as defined by study-specified laboratory tests
  6. Patients must be able to have fiducials placed for SBRT
  7. Must use acceptable form of birth control through the study
  8. Signed informed consent form
  9. Willing and able to comply with study procedures

Exclusion Criteria:

  1. Patients who have been off of mFOLFIRINOX or gemcitabine/abraxane therapy for more than 49 days
  2. Patients who have had more than one line of chemotherapy
  3. Patients with uncontrolled intercurrent illness, including but not limited to ongoing or active infection, systematic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric condition that would limit compliance with study requirements
  4. Patient who have had prior treatment with IL-2, interferon, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-OX-40, anti-CD40, or anti-CTLA-4 antibodies
  5. Patients receiving active immunosuppressive agents or chronic use of systemic corticosteroids within 14 days prior to first dose of study drug
  6. Patients who have received growth factors, including but not limited to granulocyte-colony stimulating factor (G-CSF), granulocyte macrophage-colony stimulating factor (GM-CSF), erythropoietin, etc. within 14 days of study drug administration
  7. 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 erythematous (SLE) autoimmune vasculitis, CNS or motor neuropathy considered to be of autoimmune origin.
  8. Patients who have known history of infection with HIV, hepatitis B, or hepatitis C
  9. Patients with evidence of interstitial lung disease
  10. Patients on home oxygen
  11. Patients with oxygen saturation of <92% on room air by pulse oximetry
  12. Pregnant or lactating
  13. Conditions, including alcohol or drug dependence, or intercurrent illness that would affect the patient's ability to comply with study visits and procedures
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Beth Onners, RN, BSN, MSN 410-502-2800 onnerbe@jhmi.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02648282
Other Study ID Numbers  ICMJE J15237
IRB00083132 ( Other Identifier: JHMIRB )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Sponsor  ICMJE Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators  ICMJE Merck Sharp & Dohme Corp.
Investigators  ICMJE
Principal Investigator: Lei Zheng, MD, PhD Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
PRS Account Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP