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The PRINCE Trial

Pancreatic Cancer: Can a Combination of Immunotherapy and Chemotherapy Defeat It?

Why This Trial

Pancreatic cancer is notoriously ruthless. It strikes almost 60,000 people in the United States every year and is now the third leading cause of cancer-related deaths in the nation. Only 8.5% of patients survive five years after diagnosis.

Pancreatic ductal adenocarcinoma (PDAC) is the most common form.

Earlier clinical trials with immunotherapy alone failed against this type of cancer. However, research by PICI investigator Robert Vonderheide, MD, DPhil, of the University of Pennsylvania suggested that combining immunotherapy and chemotherapy showed promise for defeating this disease.

About the Study

We tackle pancreatic cancer from different angles in this trial, now in phase 2. In addition to standard-of-care chemotherapy, we attack the tumor with two different immunotherapy agents.

One is an experimental antibody that targets the CD40 protein and propels the immune system into action. The second is a PD-1 checkpoint inhibitor that takes the brakes off the immune system so it can fight cancer more effectively.

Who’s Eligible

  • The trial is open to patients with untreated metastatic pancreatic ductal adenocarcinoma.

Treatments Tested

  • APX005M
  • Nivolumab
  • Gemcitabine and nab-paclitaxel

Results

According to promising interim phase 1b findings presented at the 2019 American Association for Cancer Research annual meeting, the novel treatment combination shrank pancreatic tumors in 20 out of 24 evaluable patients.

Where We’re At Now

The first patients underwent treatment in August 2017 at the University of Pennsylvania.

After a successful phase 1b trial, we launched phase 2 and have completed enrollment.

Researchers

Lead

Site Investigators

  • George Fisher, MD | Stanford Medicine
  • Andrew Ko, MD | University of California, San Francisco
  • Mark O’Hara, MD | University of Pennsylvania
  • Eileen O’Reilly, MD | Memorial Sloan Kettering Cancer Center
  • Gauri Varadhachary, MD | The University of Texas MD Anderson Cancer Center
  • Zev Wainberg, MD | University of California, Los Angeles

Partners

Leveraging our collaborative model, we engaged partners in academia, biotech, pharma and nonprofit to make the trial a reality, going from concept to launch in less than six months.

PICI holds the Investigational New Drug application from the U.S. Federal Drug Administration.

For more information on this trial (NCT03214250), visit www.clinicaltrials.gov.