NEO-IMPACT: NEO-adjuvant chemo-IMmunotherapy in PAnCreaTic cancer

Despite curative surgery, pancreatic cancer patients have five-year survival rates of less than 20%. Adjuvant chemotherapy has improved survival in resected pancreatic cancer patients but only 10-15% are suitable for surgery and 30% of the resected pancreatic cancer patients miss out on adjuvant chemotherapy due to postoperative complications.

Neoadjuvant chemotherapy has improved the resection rates in patients with locally advanced pancreatic cancer. Due to this success as well as the poor five-year survival rates, there has been growing interest to combine chemotherapy with checkpoint inhibitors in pancreatic cancer to help improve outcomes. This pilot study will evaluate the feasibility and safety of combining modified FOLFIRINOX (mFOLFIRINOX) with durvalumab (MEDI4736) in patients with resectable or borderline resectable pancreatic adenocarcinoma.

This is a single arm, feasibility (pilot) study.  Recruitment period of 24 months. Enrolment of 20 patients with resectable or borderline resectable pancreatic cancer, recruited from 3 participating sites in Australia. All patients will receive neo-adjuvant mFOLFIRINOX, delivered Q2W for 6 cycles and durvalumab delivered Q4W for 3 cycles. The preference will be for enrolled patients to be chemo-naïve, however, up to 1 cycle of neoadjuvant intent mFOLFIRINOX prior to study consent is allowed; these patients must be consented and enrolled on study prior to cycle 2 of treatment, so that cycle 2 contains both mFOLFIRINOX and durvalumab. Patients will then undergo restaging, discussion at MDM and surgical resection where appropriate. Following resection, patients will continue to complete 6 cycles of adjuvant chemotherapy alone. Patients will be followed up on study for 12 months from surgery, or from completion of neoadjuvant therapy if the patient does not receive surgery. Survival follow up will continue for up to 3.5 years from study enrolment.