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J18163: A Phase I/II trial of combination immunotherapy with nivolumab and a CCR2/CCR5 dual antagonist (BMS-813160) with or without GVAX following chemotherapy and radiotherapy for locally advanced pancreatic ductal adenocarcinomas (PDACs)
Protocol Number:
Phase I/II
Lei Zheng
Johns Hopkins Kimmel Cancer Center in Baltimore
This protocol aims to determine whether the combination of nivolumab, BMS-813160, and GVAX is safe in patients with locally advanced pancreas cancer and whether this combination increases the number of a certain type of immune cell entering the tumor. Other goals are to see how the combination affects survival, metastasis-free survival, response rate, resectability rate, and quality of life in patients with locally advanced pancreas cancer.
Surgically unresectable, locally advanced 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.
Enrolled patients will receive eight to sixteen 14-day cycles of FOLFIRINOX-based chemotherapy followed 2-4 weeks later by 5 days of radiation therapy (SBRT). One to two weeks after completion of SBRT, patients will receive one 28-day cycle of immunotherapy. The immunotherapy combination consists of oral BMS-813160 twice a day for 28 days and IV Nivolumab on day 1 of the 28 day cycle, with or without GVAX vaccine on Day 2 of the cycle. After one cycle of immunotherapy, patients will be evaluated for surgery. Patients who undergo surgery will resume immunotherapy 6-12 weeks later. Patients who are not surgical candidates will resume immunotherapy immediately. Both surgically resected and non-surgical candidates will receive four more 28-day cycles of immunotherapy. Patients may then receive an additional 24 weeks of immunotherapy (twice daily oral BMS-813160, IV nivolumab every 4 weeks, and one additional dose of GVAX).
Last Update
08/07/2020 05:02 AM