Melanoma is an aggressive and dangerous form of skin cancer. A new clinical trial at UVA will evaluate the potential of focused ultrasound to improve immunotherapy outcomes in combination with surgery.
A research team at UVA Health is testing the potential of focused ultrasound to increase the immune response to immunotherapy in melanoma. UVA’s work with focused ultrasound already has led to lifechanging new treatments for Parkinson’s disease and essential tremor and pushed the technology to the forefront of medical research.
UVA’s new melanoma trial will evaluate the safety and effectiveness of focused sound waves for augmenting the benefits of immunotherapy combined with surgical removal of the cancerous tumors. Led by surgical oncologist Lynn Dengel, MD, the researchers hope the sound waves will help kill the cancer cells by changing the tumor “microenvironment” and boosting the body’s immune response.
“Immunotherapy has dramatically improved our success in treating patients with advanced melanoma, but still 20% to 40% of patients do not respond,” said Dengel, an expert in melanoma and breast diseases at UVA Cancer Center. “We know that combining immune therapies improves response rates in our patients, and we seek novel therapies, such as focused ultrasound, as a mechanism of altering the immune response within the tumor.”
“We hope this trial will teach us about the immune changes seen with focused ultrasound and guide future research into this new therapy,” she said.
Targeting Melanoma
Melanoma strikes more than 100,000 Americans every year and is responsible for a majority of skin cancer deaths. It is more likely to grow and spread than other skin cancers, making it a serious health threat.
In the new clinical trial, Dengel and collaborators will enroll 11 study participants who are receiving a cancer immunotherapy drug, PD-1 antibody blockade, as part of their treatment plan. The participants will receive focused ultrasound with Theraclion’s ultrasound-guided EchoPulse device and then receive an injection into their tumor of another immunotherapy drug, Hiltinol, before undergoing surgery to remove the tumor.
The researchers will evaluate the effect of the focused soundwaves, looking at the pattern of ablation (tissue destruction in the tumor) and changes to the tumor’s immune environment.
The trial will help the researchers understand the effect of the potential new combination immune therapy bringing together focused ultrasound, immunotherapy and immune injection directly into the tumor. “This information,” Dengel said, “is vital to exploring the potential of focused ultrasound in advanced melanoma and other solid tumors.”
UVA Health’s Focused Ultrasound Research
UVA Health has been a key pioneer in the development of focused ultrasound as a marvel of 21st century medicine. Early successes by UVA neurosurgeon Jeff Elias, MD, and collaborators in using the approach to steady essential tremor, a common movement disorder, attracted national headlines and ignited worldwide interest in focused ultrasound as a minimally invasive treatment option for a potentially huge array of medical conditions.
Recognizing the potential of focused ultrasound to augment the benefits of immunotherapy, UVA Health in 2022 launched the Focused Ultrasound Cancer Immunotherapy Center, the world’s first center dedicated specifically to combining focused ultrasound and cancer immunotherapy.
UVA’s melanoma trial is being supported by the Charlottesville-based Focused Ultrasound Foundation, a longtime backer of UVA’s efforts and a key advocate for focused ultrasound research around the globe.
For more information on the melanoma clinical trial, IRB No. HSR230477, visit https://uvahealth.com/clinicaltrials/study-seeking-adult-patients-advanced-melanoma-who-are-receiving-immune-therapy-who.
If the approach proves safe and effective in the initial trial, larger trials at multiple locations would need to follow before the federal Food and Drug Administration considers making the approach available to patients.
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