Large-Scale Personalized Clinical Trial for Pancreatic Cancer

The Pancreatic Cancer Action Network is aiming to improve the lives of patients diagnosed with the third-leading cause of cancer-related death with a new precision drug trial.

Precision Promise, a large-scale trial designed to transform outcomes for patients with pancreatic cancer is expected to advance the Pancreatic Cancer Action Network’s goal to double survival by 2020, according to a recent announcement. Considering this cancer type is difficult to diagnose at an early stage and challenging to treat effectively, patients with this disease have a 5-year survival rate of just 8%.

“Precision Promise is an unprecedented opportunity for patients and is vital to move the field forward. Instead of looking for the right patient for a clinical trial, we are designing the right clinical trial for each patient,” said Julie Fleshman, JD, MBA, president and CEO of the Pancreatic Cancer Action Network.

To move this project forward, the Pancreatic Cancer Action Network has committed a minimum initial investment of $35 million during the first 4 years, not including drug costs. They plan for thousands of patients to enroll. What's more, this is a very collaborative effort. Starting in 2017, 12 initial Precision Promise Clinical Trial Consortium sites in the United States have been selected to participate in this initiative.

This trial sets itself apart from other clinical trials in that it takes in more specific information about patients-through molecular profiling-to inform treatment decisions. This translates to a treatment that may work for patients, and for whom it confers no benefit, the treatment is then modified to a different regimen. More specifically, this trial will investigate multiple treatment options, called substudies, under one clinical trial design that uses an individualized treatment approach harnessing the power of the molecular profile of a patient and tumor type to provide the most specific treatment plan.

Precision Promise will work with health tech company, Tempus, to use their genomic sequencing and analysis methods. Additionally, Cancer Research And Biostatistics will serve as the Precision Promise Contract Research Organization to provide statistical analyses, data management support as well as clinical monitoring for the trials.