The trial evaluates the immunotherapy drug durvalumab as maintenance therapy in patients who have successfully undergone R0/R1 resection of pancreatic ductal adenocarcinoma following neoadjuvant chemotherapy and completion of adjuvant chemotherapy.
A clinical trial at the University of Colorado Cancer Center is testing durvalumab following surgery for pancreatic cancer.
Even after chemotherapy, radiation, and surgery, pancreatic often returns, and with a poor prognosis. “Right now, after a patient has finished chemotherapy, radiation, and then had a successful surgery for pancreatic cancer, there’s not much to do other than surveillance with periodic blood tests and imaging,” said Gentry King, MD, chief fellow, medical oncology, UCHealth, in a statement. “But many people want to be proactive in trying to keep it from coming back since it is such an aggressive cancer."
This clinical trial allows patients to receive immunotherapy in addition to observation, said King. The 2-arm, open-label study (NCT03038477) evaluates the immunotherapy drug durvalumab as maintenance therapy in patients who have successfully undergone R0/R1 resection of pancreatic ductal adenocarcinoma following neoadjuvant chemotherapy and completion of adjuvant chemotherapy.
Within 1 to 3 months of treatment completion, patients are enrolled in the trial and randomized at a 1:1 ratio to be administered durvalumab or receive monitoring for tumor growth; there will be 56 patients enrolled per arm. Patients in the durvalumab arm are given the anti—PD-L1 antibody every 2 weeks for a maximum of 26 doses if there is no radiographic evidence of disease recurrence. One cycle constitutes 2 durvalumab treatments on day 1 and day 15, respectively, repeated every 28 days.
“The concept is that chemotherapy and radiation may make pancreatic cancer especially susceptible to immunotherapy,” said Wells Messersmith, MD, co-leader of CU Cancer Center Developmental Therapeutics Program and the trial’s principal investigator, in a statement. “In giving this therapy when the cancer has already been minimized by chemo, radiation, and surgery, we hope it will continue to act against residual disease in a way that prevents recurrence.”
The primary outcome measure of the trial is the number of patients with disease-free survival. Secondary outcome measures are overall survival of the patients and the number of patients who experience adverse events.