The targeted immunotherapy drug ibrutinib is already approved to treat certain types of leukemia and lymphoma. This is a clinical trial looking for the best dose of this drug to use with gemcitabine and nab-paclitaxel in patients with stage IV pancreatic cancer.
Understanding Targeted Therapy
Targeted therapy means to use a drug that specifically targets a molecular feature of a cancer cell, usually one that is enabling the cancer to grow, in order to change how that cancerous cell is working, or maybe even kill it. B cells are a part of the immune system. Malignant B cells have been shown to promote the development and progression of pancreatic cancer.
Ibrutinib works by inhibiting a type of signaling molecule in the cell called a kinase (specifically Bruton’s tyrosine kinase, or BTK). In the laboratory, ibrutinib can reprogram the malignant B cells so they do not promote the cancer, and also to increase the number of cancer-killing CD8+ T cells.
How the Trial Works
All participants will receive chemotherapy with gemcitabine, which is converted into two metabolites that cause cell death (one reduces the number of proteins available to make DNA; the other shortens the DNA strands) and nab-paclitaxel, which inhibits cell division and promotes cell death.
Ibrutinib will be given along with the gemcitabine and nab-paclitaxel. One group of participants will receive increasing doses of ibrutinib, to determine the safest dose of the drug. The other group will receive only the experimental drug for a week, and then the standard treatment will be added. These participants will have biopsies before and after the ibrutinib treatment, to measure the immune response.
This trial is for stage IV pancreatic cancer patients whose tumor has not been surgically removed.
We encourage you to consult your physicians for clinical trials that may be right for you. The website ClinicalTrials.gov provides more details about this trial as well as many others. You can visit the Clinical Trial Finder for a listing of all active pancreatic cancer clinical trials.