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J1756: A Phase II Clinical Trial of GVAX Pancreas Vaccine (with Cyclophosphamide) in Combination with Nivolumab and Stereotactic Body Radiation Therapy (SBRT) Followed by Definitive Resection for Patients with Borderline Resectable Pancreatic Adenocarcinoma
Protocol Number:
Phase II
Daniel Laheru
Johns Hopkins Kimmel Cancer Center in Baltimore
This new protocol aims to determine the the pathologic complete response (pCR) rate, as defined by no residual cancer in the primary pancreatic tissue or nodes (ypT0ypN0) at surgical resection, of borderline resectable pancreatic ductal adenocarcinoma (borderline resectable pancreatic cancer) treated with neoadjuvant sequential chemotherapy, SBRT, and cyclophosphamide/GVAX/nivolumab immunotherapy.
Histologically prove, borderline resectable pancreatic adenocarcinoma. No evidence of metastases. Adequate hematologic, renal, and liver function. 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 immunosuppressive agents (systemic steroids) for 14 days prior to starting treatment. No non-oncology vaccinations within 28 days.
Four 28-day cycles of FOLFIRINOX given. Approx. 4-6 weeks later, 2 doses of Nivolumab + Cyclophosphamide + GVAX will be given 3 weeks apart. Radiation therapy (SBRT) will be given the same day as the second dose. Completion of immunotherapy and SBRT will be followed by definitive resection.
Last Update
08/08/2020 05:02 AM