Innovative clinical trial opens at Stephenson Cancer Center


Cancer diagnosis is not a one-size-fits-all proposition nor is cancer treatment. Now, a new clinical trial at the Stephenson Cancer Center will help match cancer patients with the best treatment option for their specific cancer.
The clinical trial, funded by the National Cancer Institute is called MATCH, which stands for Molecular Analysis for Therapy Choice. It will analyze patients’ tumors to determine whether they contain genetic abnormalities for which a targeted drug exists and then assign treatment based on that abnormality. The goal is to determine whether treating cancers according to their molecular “fingerprint” will improve effectiveness. It’s a unique study, rooted in an approach known as precision medicine.
“Many trials enroll patients based on tumor type, for instance, a breast cancer trial that enrolls only patients with a specific tumor type to test a single therapy. The MATCH trial is different. It isn’t one trial of one therapy,” said gynecologic oncologist Kathleen Moore, M.D., principal investigator for the trial at Stephenson Cancer Center. “So we are essentially matching drugs and mutations, regardless of the type of tumor you have.”
She added this approach opens up opportunities for patients to access therapies they may not have had access to otherwise, either because those therapies were not traditionally available for their tumor type or because they didn’t have access to this sort of molecular profiling.
The NCI-MATCH trial aims to screen about 3,000 patients at 2400 sites across the United States, including the Stephenson Cancer Center with a goal of enrolling about 1,000. The trial is open to cancer patients 18 years of age and older with advanced solid tumors and lymphomas that are no longer responding or have never responded to standard therapy and have begun to grow.
In the screening phase, patients will undergo a biopsy procedure. Specimens removed from patients’ tumors will then be sent to one of four genetic testing labs, where they will be analyzed for more than 4,000 variants across 143 genes.
Moore pointed out that NCI-MATCH provides molecular/genetic profiling done on fresh tumor biopsies.
“This is important because the mutations that are present in a tumor at the time of original diagnosis, which may have been years before, may be different than those that are present at the time of recurrence, after chemotherapy or after other targeted treatments,” she explained.
The study also will have many more drugs available than most clinical trials. It’s anticipated that 25 to 40 drugs ultimately will be tested, each in a different arm of the trial.
“NCI-MATCH will have a rolling selection of study drugs that target different mutations with an eye toward studying combination agents in the future,” Moore explained.
The trial drugs have all either been approved by the U.S. Food and Drug Administration for another cancer indication or are still being tested in other clinical trials but have shown some effectiveness against tumors with a particular genetic mutation.
Many clinical trials are focused on more common tumors such as breast, non-small cell lung cancer, colon cancer and prostate cancer. Patients with these diseases are encouraged to participate in the MATCH trial. However, a quarter of the spots will be reserved for less common cancers such as sarcomas, gynecologic cancers, head and neck cancers.
Moore said the goal is to gain a better understanding of the frequency of actionable mutations in patients with rare cancers and to assess responses to targeted therapies in patients who would not otherwise have access to these drugs. “Rare cancers are very difficult to study because clinical trials are not as feasible. So it is harder to find new drugs that are effective for them. By including a large number of rare tumors, we can offer treatment with novel agents to a wider audience of patients and have a higher likelihood of determining efficacy,” she said.
NCI-MATCH moves the field away from organ-specific clinical research and into molecularly-targeted trials. “In the end, I think we will need both models to be successful,” Moore said, “but this will help us identify critical mutations and effective therapies faster, and then bring them back to benefit more patients.”
The NCI-MATCH trial also referred to as EAY131 and NCT02465060 is sponsored by the NCI Division of Cancer Treatment and Diagnosis.