UNC Hospitals’ head and neck oncology experts have launched a first-of-its-kind clinical trial aimed at improving outcomes in BRAF wildtype (lacking the BRAF mutation) anaplastic thyroid cancer (ATC). Patients with this specific cancer lack effective treatment options and face poor survival rates.
Siddharth Sheth, DO, MPH, and Jeffrey Blumberg, MD, FACS, are leading a multidisciplinary team at UNC dedicated to the treatment of ATC. They have designed a clinical trial to investigate a pioneering therapeutic approach that combines zanzalinitinib, a novel tyrosine kinase inhibitor, and cemiplimab, an immunotherapy, prior to surgery. The trial is designed to offer hope to the almost 60% of ATC patients without a BRAF mutation and are often excluded from existing targeted therapy options.
ATC is rare, with an estimated 500 to 800 new cases diagnosed each year in the United States, according to the American Thyroid Association. Patients are typically diagnosed at an advanced stage, which makes surgery difficult or impossible. These cancers typically respond poorly to traditional chemotherapy.
“Anaplastic thyroid cancer is one of the most aggressive and lethal cancers,” said Blumberg, a surgical oncologist. “Historically, median survival was just six months. While BRAF-mutated ATC patients now have more effective treatment options, the rest have not seen progression. This trial is about changing that.”
The Phase 1 clinical trial, developed at UNC Lineberger Comprehensive Cancer Center, is the only study in the world evaluating therapy prior to surgery BRAF wildtype ATC patients. “Our goal is to shrink the tumors, decrease cancer-related symptoms, and give our surgical colleagues a better chance at completely removing the tumor. Achieving this will allow patients to have a better chance at long-term survival,” said Sheth, a medical oncologist.
Dana-Farber Cancer Institute has joined as a second site, underscoring the national significance of the study. This trial has also been endorsed by the International Thyroid Oncology Group (ITOG).
Fast-tracking ATC treatment
UNC’s team has built a rapid-response infrastructure to fast-track diagnosis and treatment. Patients are seen quickly by a coordinated team of surgical, medical, and radiation oncologists, supported by pathology, speech therapy, nutrition, nurse navigation, and other supportive care services.
“We’ve created a system where patients can be evaluated quickly and treated without delay,” said Blumberg, a head and neck surgeon. “This approach is critical for ATC as patients have a short window to start treatment to prevent advancement of the disease.”
The trial is open to patients with both resectable and unresectable disease, with the goal of shrinking tumors to make surgery possible. “Surgery remains the best chance for long-term survival,” Blumberg said. “We’re trying to give more patients that chance.”
“This clinical trial is just the beginning,” Sheth said. “Our goal is to build on its momentum and eventually expand to a national, multi-center study that could change how we treat anaplastic thyroid cancer. For patients who have had no options, we are working to change that.”
UNC Health sees a large volume of head and neck cancer cases in North Carolina and treats patients from across the Southeast. The team’s expertise in head and neck disease and comprehensive approach to care has garnered a growing national reputation.
“This is a rare opportunity to move the needle on outcomes in a disease where progress has been elusive,” Sheth said. “We want providers to know that there is hope, and that UNC is the place to send their ATC patients.”
For referring providers, UNC encourages early outreach. Patients interested in the trial can contact the Clinical Trials Office directly at cancerclinicaltrials@med.unc.edu or visit the clinical trial study details page to learn more.