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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

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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: Cyclophosphamide Drug: GVAX Drug: Pembrolizumab Radiation: SBRT Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : July 12, 2016
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cyclophosphamide, Pembrolizumab, GVAX, SBRT 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




Primary Outcome Measures :
  1. Distant Metastasis Free Survival (DMFS) [ Time Frame: 4 years ]

Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: 4 years ]
  2. Local Progression Free Survival (LPFS) [ Time Frame: 4 years ]
  3. Number of participants experiencing immune-related toxicities (IRAEs) [ Time Frame: 4 years ]


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02648282


Contacts
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Contact: Beth Onners, RN, BSN, MSN 410-502-2800 onnerbe@jhmi.edu

Locations
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United States, Maryland
The Sidney Kimmel Comprehensive Cancer at Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21231
Contact: Beth Onners, RN, BSN, MSN    410-502-2800    onnerbe@jhmi.edu   
Contact: Lei Zheng, MD, PhD         
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Merck Sharp & Dohme Corp.
Investigators
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Principal Investigator: Lei Zheng, MD, PhD Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT02648282     History of Changes
Other Study ID Numbers: J15237
IRB00083132 ( Other Identifier: JHMIRB )
First Posted: January 7, 2016    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
vaccine
immunotherapy
antibody
PD-1
radiation

Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Pancreatic Diseases
Digestive System Diseases
Endocrine System Diseases
Cyclophosphamide
Pembrolizumab
Vaccines
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Immunological