Giving patients more treatment options at every stage of care
By Judy Germany
Rush's cancer clinical trials program experienced a renaissance in 2016, including the arrival of Timothy M. Kuzel, MD, as chief of the Division of Hematology, Oncology and Cell Therapy. Not only has the number of open trials multiplied — from around 30 in early 2015 to nearly 150 by the end of 2016 — but the focus of the research has broadened.
"Historically, our trials were mostly for breast cancer and lung cancer," says Crista Brawley, PhD, CCRP, director of cancer clinical trials. "But thanks to Dr. Kuzel's leadership and vision, we are also building up our genitourinary cancer, melanoma, lymphoma, pancreatic cancer, and head and neck cancer research programs."
The expansion includes several early-phase, multisite trials, including studies of immunotherapy and other targeted therapies.
A perfect match
It's not a coincidence that the newer trials align with Rush's patient population and areas of clinical expertise. "We want to make sure every study we take is a good fit for the types of cancers our oncologists treat," Brawley says.
In addition to ensuring peak enrollment, this approach gives patients more treatment options at every stage of care. "Clinical trials are baked into routine cancer care here," Brawley explains. "Our oncologists view trials as viable options — not just last-ditch treatments — and do a terrific job of finding qualified patients to enroll. They are involved in these studies and believe in them."
Kuzel, for instance, brought his decadeslong passion for immunotherapy to Rush, an institution already known for its pioneering use of immunotherapeutic agents. Rush was a leader in trials for Herceptin and TDM-1 — known as "super Herceptin" — for HER 2-positive breast cancer. Investigators at Rush have also participated in trials for lung cancer, melanoma and prostate cancer vaccines.
A nationally recognized authority in this rapidly evolving field, Kuzel is now conducting immunotherapy research at Rush across a wider range of disease sites. And he brought several basic scientists into the Division of Hematology, Oncology and Cell Therapy to help develop the next generation of targeted strategies.
Delivering a one-two punch
Perhaps the most promising results are coming from combination immunotherapeutic approaches, which are being studied for patients who don't respond to single-drug regimens.
One combined therapy already FDA-approved for melanoma marries ipilimumab and nivolumab, two checkpoint inhibitors that block receptor molecules on the surface of immune T cells. Kuzel is currently leading a trial comparing ipilimumab and nivolumab vs. anti-LAG-3 antibody and nivolumab for renal cancer; Rush was the first site in the U.S. to enroll a patient.
"We are seeing that when we combine therapies we often get higher rates of response and better efficacy," Kuzel says. "So there is definitely reason to be encouraged by this approach."
Streamlining the process
With so many immunotherapy drugs being developed, and at such a fast pace, studying all of the various combinations is challenging. "It requires a lot of both patients and patience to get results," Kuzel says.
To expedite the process, Rush has partnered with a pharmaceutical company to administer small, rapid rotations of various combination immunotherapies to renal cancer patients.
The goal is to get these drugs to patients faster and more efficiently so clinicians can identify sooner whether a specific treatment warrants a more exhaustive trial.
"The process can take years. That's why we are looking at novel trial designs that enable us to know sooner whether a treatment has any merit," Kuzel says. "If it does, we can then move more quickly into a large randomized trial that the FDA would sanction for approval."
A personalized approach
Brawley and her colleagues in the Cancer Clinical Trials Office share Kuzel's — and Rush's — commitment to bringing the latest therapies to patients.
That's why cancer research nurses participate in all comprehensive cancer clinics and conferences. "We have a seat at the table along with the physicians, so we're able to present any trials that may be good options for specific patients," Brawley says. "Our goal is to make sure both the care teams and patients are able to make fully informed treatment decisions."
The cancer clinical trials staff grew by more than 200 percent in 2016 to help investigators develop, activate and manage the influx of new trials.
With Kuzel at the helm and all of the operational pieces in place, the program anticipates continued expansion. "But more important than simply increasing volumes," Kuzel says, "patients are coming to Rush for trials because we offer the novel trials they are seeking."