The PRINCE Trial
Evaluating the Safety and Efficacy of a CD40 Antibody, Anti-PD-1 Checkpoint Inhibitor and Chemotherapy in Combination
Pancreatic cancer remains notoriously difficult to treat, with the number of people who die from this disease on the rise.
Pancreatic cancer is now the third leading cause of cancer-related deaths in the nation, surpassing breast cancer, according to 2017 estimates from the National Cancer Institute. The deadly disease will kill more than 43,000 people in the United States this year.
Few advances have been made over the last 10 years. However, preliminary studies suggest that using chemotherapy with immunotherapy may improve patient outcomes.
Based on preclinical studies supporting this idea and the unmet need for this type of tumor, the Parker Institute chose to launch a trial to test this innovative combination of drugs.
ABOUT THE STUDY
This phase 1b/2 open-label study will explore the combination of chemotherapy and two immunotherapy agents. One immune therapy is an antibody targeting CD40, a protein that when activated can drive the immune system to attack tumors. The other is an anti-PD-1 checkpoint inhibitor, which helps take the brakes off the immune system so it can more effectively tackle cancers.
In phase 1, investigators will evaluate the safety of the combined treatments. Each patient will receive gemcitabine and nab-paclitaxel, two chemotherapy treatments that are standard of care. Those will be tested in combination with the CD40 antibody APX005M from Apexigen and the anti-PD-1 checkpoint inhibitor nivolumab from Bristol-Myers Squibb. For additional information on this clinical trial (NCT03214250), please visit www.clinicaltrials.gov.
Leveraging the Parker Institute’s collaborative model, the trial went from a concept to launch in less than six months, demonstrating the Parker Institute’s ability to develop faster, more efficient multi-center investigations.
This trial is the Parker Institute’s first clinical collaboration with Apexigen, Bristol-Myers Squibb and the Cancer Research Institute.
The study opened in July 2017 and is now in phase 2, which is open for enrollment. The first patients began receiving treatment in August 2017 at the University of Pennsylvania. Other participating sites for this trial include Dana-Farber Cancer Institute, MD Anderson Cancer Center, Memorial Sloan Kettering Cancer Center, Stanford Medicine, UCLA and UCSF.
The research team presented a poster about the clinical trial at the 2017 Society for Immunotherapy of Cancer annual meeting.