A new multi-site clinical trial is testing different combinations of immunotherapy as first-line treatment for metastatic pancreatic cancer patients using a novel way of conducting trials.
A Platform Trial
The trial uses a “master protocol”—a single study design that is broken into smaller substudies to try different drug combinations or treatments. This particular trial is a “platform” trial, in which the treatments can be adapted depending on the patient’s response. The researchers interpret the data during the trial and make changes to the treatment accordingly. The changes might include testing additional treatments, expanding the number of people receiving a therapy that shows promise, or discontinuing a therapy that is not effective.
Testing Immunotherapy Combinations
The trial consists of two groups of patients. Each cohort will test a different immunotherapy combination. In an initial phase (stage 1) the researchers evaluate the safety, biomarkers and/or clinical activity of the tested combination. In case of promising results during stage 1, the cohort is expanded to additional participants. Biopsies will be taken before the trial starts (baseline) and while participants are in treatment.
Cohort A will test a combination of the standard-of-care chemotherapy nab-paclitaxel and gemcitabine plus the CTLA-4 inhibitor ipilimumab and the PD-1 inhibitor nivolumab. Cohort B will receive the combination of nab-paclitaxel and gemcitabine, ipilimumab, and hydroxychloroquine—a drug that is best known as a treatment for malaria. Hydroxychloroquine has been shown to stop autophagy, a process in which cells recycle their own materials to survive, believed to be a key mechanism metastatic pancreatic cancer cells use to evade the immune system.
The flexibility built into the trial design will allow researchers to modify and/or add new combinations to the protocol as data emerge from scientific findings.
In addition to testing the safety and effectiveness of the treatments, the study will be used to explore how biomarker data can best be used to determine which patients stand to benefit from immunotherapy.
Joining the Trial
This is an exploratory trial for patients with metastatic pancreatic cancer, either newly diagnosed or with recurrent disease that has not been treated for more than four months before joining the study.
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 EmergingMed Trial Finder for a list of all active pancreatic cancer clinical trials.