Multi-Site Precision Promise Study Opens

In simplest terms, clinical trials advance the care of pancreatic cancer patients by answering two very important questions: What works? And, what doesn’t work?

The problem, however, is that to get to those answers often requires a long, cumbersome, and expensive process. Though all trials do advance knowledge, there is often no payoff in terms of finding those new, more effective ways of treating pancreatic cancer—a disease that’s slated to become the second-leading cause of cancer mortality. Standard trials have had only about a 10 percent success rate finding new treatments over the last two decades.

A bold effort spearheaded by the Pancreatic Cancer Action Network (PanCAN) hopes to change that dynamic with a new trial called Precision Promise^SM, a phase II/III study focusing on personalized, molecularly driven, science-based treatments for study participants. Its goal is to streamline the clinical trial process in hopes of bringing effective treatments from the laboratory to clinical practice more quickly and efficiently.

“Pancreatic cancer survival is often measured in months, not in the years it takes to complete trials,” explains medical oncologist Dr. Vincent Picozzi, director of the Pancreatic Cancer Center of Excellence at Virginia Mason (Seattle) and co-principal investigator for Precision Promise. He is also a member, and past chair, of the PanCAN Scientific and Medical Advisory Board and principal investigator for Precision Promise at Virginia Mason. “With (clinical trials) you need to be far more resource efficient because time is of the essence for patients.”

Picozzi is no stranger to pancreatic cancer, having devoted more than two decades to caring for patients with the disease. “Twenty or so years ago there wasn’t much we could do for patients and it was frustrating as a physician and devastating for patients,” he says. “Admittedly, we have made progress, yet pancreatic cancer still has a very poor prognosis. Improving that prognosis will require dramatic process changes as to how we do clinical trials.”

About the Trial

Precision Promise is open to participants with metastatic pancreatic cancer who have not yet had treatment, or whose disease has progressed on first-line treatment. One of the hallmarks of the trial is its so-called “adaptive” design, which allows for the testing of multiple therapies at the same time, and allocates patients to treatment arms based on the probability of success. In other words, the trial adapts to the evolving results, Picozzi explains.

By virtue of the design, far fewer participants will be needed to determine if a drug is indeed working. This will cut the time it takes to conduct a clinical trial by about 50 percent. In a boon for participants, they could potentially receive both first- and second-line treatment within the Precision Promise framework.

The technology company Tempus will test participants for targetable molecular markers. Follow-up biopsies will also be done to determine how a patient’s tumor is actually responding to treatment on a molecular level. And the trial will also study supportive care and address quality of life issues, pain management, symptom and side effect management, and activity levels, as well as other issues that can affect a pancreatic cancer patient’s overall well-being.

“The trial is efficient; it leverages the resources in a way that upgrades the chance of success,” Picozzi notes, citing that pharmaceutical companies can often be a little leery of pancreatic cancer drug development since the success rate for new treatments has historically been low. “Traditional clinical trials can be a long and very costly proposition for a drug company, but this kind of trial design opens up the space since drugs will be tested much more quickly and that translates into less expense.”

The trial design also wasn’t done in a vacuum, Picozzi explains. “They (PanCAN) brought everyone to the table including leading pancreatic cancer clinicians and scientists, statisticians, drug developers, regulatory agencies, and others involved in the process of getting a drug out of the lab and approved for patients,” he adds. “It was actually pretty remarkable.”

While the hope of getting new treatments to patients quickly and cost-effectively seems like a lofty goal, Picozzi believes the time is right. “Pancreatic cancer is very heterogeneous and it’s not likely that any one mechanism of action is going to completely turn the tide,” he says. “But molecularly determined therapy will be a big part of new treatment approaches, and we are also going to find ways to link translational work in other areas into clinical practice. That’s the precision part of this.

“I see about 200 to 250 new pancreatic cancer patients each year, and I can appreciate how much care has improved, but it has to get better—and it has to get better more quickly. I think one of the great things is that through this trial we can hopefully accelerate that progress through this entirely new research mechanism. That’s the promise part of the trial.

“I like baseball and baseball analogies. With this trial we have a chance to get to the playoffs faster. And that’s what every pancreatic cancer patient needs.”

Precision Promise Sites

Eligible pancreatic cancer patients will be able to enroll in PanCAN’s Precision Promise study 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)
• Dana-Farber/Harvard Cancer Center (Boston)
• Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance/University of Washington (Seattle)
• Johns Hopkins Medicine (Baltimore, Maryland)
• Memorial Sloan Kettering Cancer Center (New York City)
• Moores Cancer Center at UC San Diego Health (San Diego, California)
• Perelman Center for Advanced Medicine, University of Pennsylvania (Philadelphia, Pennsylvania)
• Perlmutter Cancer Center/NYU Langone Health (New York City)
• University of Chicago Medicine Comprehensive Cancer Center (Chicago, Illinois)
• University of Texas MD Anderson Cancer Center (Houston, Texas)
• UCSF Helen Diller Family Comprehensive Cancer Center (San Francisco, California)
• University of Florida Health Cancer Center (Gainesville, Florida)
• Virginia Mason Medical Center (Seattle)
• Washington University School of Medicine (St. Louis, Missouri)
• Weill Cornell Medicine (New York City)

For a full list of institutions that are open and actively enrolling patients, go to PanCAN’s Precision Promise locations page. More information about Precision Promise eligibility and protocols is available on the ClinicalTrials.gov website.