Clinical Trials /

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

NCT02648282

Description:

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.

Related Conditions:
  • Pancreatic Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Study With CY, Pembrolizumab, GVAX, and SBRT in Patients With Locally Advanced Pancreatic Cancer
  • 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

Clinical Trial IDs

  • ORG STUDY ID: J15237
  • SECONDARY ID: IRB00083132
  • NCT ID: NCT02648282

Conditions

  • Pancreatic Cancer

Interventions

DrugSynonymsArms
CyclophosphamideCytoxan, CYCyclophosphamide, Pembrolizumab, GVAX, SBRT
GVAXPancreatic cancer vaccine, Panc 10.05 pcDNA1/GM-Neo, Panc 6.03 pcDNA1/GM-NeoCyclophosphamide, Pembrolizumab, GVAX, SBRT
PembrolizumabMK-3475, KEYTRUDACyclophosphamide, Pembrolizumab, GVAX, SBRT

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Cyclophosphamide, Pembrolizumab, GVAX, SBRTExperimental
  • Cyclophosphamide
  • GVAX
  • Pembrolizumab

Eligibility 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
      
Maximum Eligible Age:100 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Distant Metastasis Free Survival (DMFS)
Time Frame:4 years
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Overall Survival (OS)
Time Frame:4 years
Safety Issue:
Description:
Measure:Local Progression Free Survival (LPFS)
Time Frame:4 years
Safety Issue:
Description:
Measure:Number of participants experiencing immune-related toxicities (IRAEs)
Time Frame:4 years
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Sidney Kimmel Comprehensive Cancer Center

Trial Keywords

  • vaccine
  • immunotherapy
  • antibody
  • PD-1
  • radiation

Last Updated

March 21, 2017