Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02648282
Recruitment Status : Active, not recruiting
First Posted : January 7, 2016
Last Update Posted : February 4, 2021
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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: N/A
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 2021
Estimated Study Completion Date : July 2021

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

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. Number of participants experiencing immune-related toxicities (IRAEs) [ Time Frame: 4 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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 identifier (NCT number): NCT02648282

Layout table for location information
United States, Maryland
The Sidney Kimmel Comprehensive Cancer at Johns Hopkins
Baltimore, Maryland, United States, 21231
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Merck Sharp & Dohme Corp.
Layout table for investigator information
Principal Investigator: Lei Zheng, MD, PhD Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Layout table for additonal information
Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Identifier: NCT02648282    
Other Study ID Numbers: J15237
IRB00083132 ( Other Identifier: JHMIRB )
First Posted: January 7, 2016    Key Record Dates
Last Update Posted: February 4, 2021
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
Additional relevant MeSH terms:
Layout table for MeSH terms
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
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