Ibrutinib Combined With Gemcitabine and Nab-Paclitaxel in Patients With Metastatic Pancreatic Cancer
Status:
Completed
Trial end date:
2020-09-01
Target enrollment:
Participant gender:
Summary
Gemcitabine and nab-paclitaxel is a standard regimen (NCCN, Category 1) for patients with
metastatic pancreatic ductal adenocarcinoma (PDAC). However, further improvement in treatment
is needed. Increasingly, the nature of the immune infiltrate in PDAC appears to be tumor
promoting. In preclinical studies, ibrutinib treatment, presumably by reprogramming B cells,
results in increased CD8+ T cells to assist in tumor control. Preclinical studies of
ibrutinib plus gemcitabine show superior antitumor effects compared to gemcitabine alone in
both orthotopic murine pancreatic cancer cell line grafts and in genetically engineered mouse
models. Thus, the investigators propose a clinical trial of ibrutinib plus the standard
gemcitabine based regimen of gemcitabine and nab-paclitaxel, evaluating safety, then efficacy
and including correlative studies.