Broad Adaptive Pancreatic Clinical Trial Platform Launched

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Microscopic image of mitochondrial stained pancreatic cancer cells
Mitochondrial staining (red) and nuclear staining (blue) of abnormal pancreatic ducts from a mouse model of human pancreatic ductal carcinoma. Mitochondrial shape changes occur throughout the progression of pancreatic cancer.

The Pancreatic Cancer Action Network (PanCAN) announced earlier this week the launch of Precision Promise, an adaptive clinical trial platform for pancreatic cancer designed to gather leading stakeholders in developing novel treatments in order to bring them to patients faster. According to PanCAN, the platform is the first of its kind for pancreatic cancer and has the potential to transform the clinical research landscape.

“Pancreatic cancer patients don’t have time to wait for new treatments to be approved through the standard clinical trial model,” said Julie Fleshman, PanCAN’s president and CEO in a press release. “As the first pancreatic cancer nonprofit organization to develop, sponsor, and lead an adaptive clinical trial platform, we are disrupting the current clinical trial system in order to accelerate progress for patients fighting this disease.”

The goal of the Precision Promise, PanCAN states, is to improve the speed at which effective drugs can come to market and reduce the overall cost of running clinical trials. It seeks to accomplish this by designing a clinical trial platform by testing multiple experimental therapies at the same time. Through the new clinical trial platform, metastatic pancreatic cancer patients may have the opportunity to receive both first- and second-line treatment options in one clinical trial. The new late-stage trial model hopes to accelerate the drug development and approval timeline by as much as two years.

The statistical design of Precision Promise was led by world-renowned statistician Dr. Donald Berry of Berry Consultants, who also designed the I-SPY breast cancer trials and has more than 400 peer-reviewed publications to his name.

Eligible pancreatic cancer patients will be able to enroll in PanCAN’s Precision Promise at one of 15 Clinical Trial Consortium sites nationwide. Sites were selected through a competitive, peer-review process and include:

  • Cedars-Sinai Medical Center (Los Angeles, Calif.)
  • Dana-Farber/Harvard Cancer Center (Boston, Mass.)
  • Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance/University of Washington (Seattle, Wash.)
  • Johns Hopkins Medicine (Baltimore, Md.)
  • Memorial Sloan Kettering Cancer Center (New York City, N.Y.)
  • Moores Cancer Center at UC San Diego Health (San Diego, Calif.)
  • Perelman School of Medicine University of Pennsylvania (Philadelphia, Pa.)
  • Perlmutter Cancer Center/NYU Langone Health (New York City, N.Y.)
  • The University of Chicago (Chicago, Ill.)
  • The University of Texas MD Anderson Cancer Center (Houston, Texas)
  • UC San Francisco Helen Diller Family Comprehensive Cancer Center (San Francisco, Calif.)
  • University of Florida Health – Cancer Center (Gainesville, Fla.)
  • Virginia Mason Medical Center (Seattle, Wash.)
  • Washington University School of Medicine (St. Louis, Mo.)
  • Weill Cornell Medicine (New York City, N.Y.)

In partnership with Tempus, a leader in artificial intelligence and precision medicine, every patient enrolled in PanCAN’s Precision Promise trial will undergo broad-panel genomic testing. Precision promise will also support follow-up biopsies to learn how their tumor is responding to treatment. Through the adaptive nature of PanCAN’s Precision Promise, data will be constantly monitored, and treatment arms can be discontinued if results do not look promising.

“By designing a more patient-centric trial platform, we are able to test promising new therapies more quickly and learn from fewer patients if a treatment is working,” said Diane Simeone, MD, chair of the PanCAN Precision Promise Steering Committee and Precision Promise Principal Investigator at Perlmutter Cancer Center at NYU Langone Health. “The patients that enroll will also receive best-in-class supportive care alongside treatment with biomarker testing to better understand why treatments work in some patients but not in others. This approach should serve as a model for the next generation of trials – not only for pancreatic cancer, but for all diseases.”

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