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Title:
J15237: 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
Protocol Number:
J15237
Phase:
Phase II
Physician:
Lei Zheng
Sites:
Johns Hopkins Kimmel Cancer Center in Baltimore
Purpose:
This research is being done to determine the distant metastasis free survival (DMFS) in people with locally advanced pancreatic cancer (LAPC) who have received standard chemotherapy, who are treated with pancreatic cancer vaccine (GVAX) and pembrolizumab before, during, and after stereotactic body radiation therapy (SBRT).
Eligibility:
Histologically proven, surgically unresectable, locally advanced pancreatic adenocarcinoma. No evidence of metastases after 4 cycles of Folfirinox-based chemotherapy or Gemcitabine + Abraxane chemotherapy. Adequate hematologic, kidney, and liver function. Must be able to have SBRT at Johns Hopkins Hospital. Must not have been off chemotherapy for more than 49 days. No prior treatment with immunotherapy agents or investigational drugs or devices. No history of autoimmune diseases. No history of HIV, Hepatitis B or C. No immunosupressive agents (systemic steroids) for 14 days prior to starting treatment. No non-oncology vaccinations within 28 days.
Treatment:
2 doses of Pembrolizumab + Cyclophosphamide + GVAX will be given 3 weeks apart. Radiation therapy (SBRT) will be given the same day as the second dose. 4-6 weeks later, patients will be evaluated for surgery. Patients that are not candidates for surgery will have a biopsy. After surgery or biopsy, patients will receive 2 more cycles of chemotherapy (FOLFIRINOX-based or Gem/Abraxane). Following chemotherapy, patients will receive 6 more doses of Pembrolizumab + Cy + GVAX.
Population:
Adult
Last Update
03/05/2019 05:03 AM