Study With CY, Pembrolizumab, GVAX Pancreas Vaccine, and SBRT in Patients With Locally Advanced P… (NCT02648282) | Clinical Trial Compass
CompletedPhase 2
Study With CY, Pembrolizumab, GVAX Pancreas Vaccine, and SBRT in Patients With Locally Advanced Pancreatic Cancer
United States58 participantsStarted 2016-07-18
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Locally advanced pancreatic adenocarcinoma
✓. 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.
✓. Age \>18 years
✓. No metastatic disease
✓. ECOG Performance Status of 0 to 1
✓. Adequate organ function as defined by study-specified laboratory tests
✓. Patients must be able to have fiducials placed for SBRT
✓. Must use acceptable form of birth control through the study
Exclusion criteria
✕. Patients who have been off of mFOLFIRINOX or gemcitabine/abraxane therapy for more than 49 days
✕. Patients who have had more than one line of chemotherapy
✕. 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
✕. 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
What they're measuring
1
Distant Metastasis Free Survival (DMFS)
Timeframe: 62 months
Trial details
NCT IDNCT02648282
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
. Patients receiving active immunosuppressive agents or chronic use of systemic corticosteroids within 14 days prior to first dose of study drug
✕. 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
✕. 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.
✕. Patients who have known history of infection with HIV, hepatitis B, or hepatitis C