Key Points
- The first participant has been treated in a clinical trial investigating the use of focused ultrasound histotripsy plus immunotherapy to address metastatic or unresectable cancers.
- The Focused Ultrasound Foundation is co-funding the treatment of the first six participants in the study.
The first participant has been treated in a clinical trial investigating the use of focused ultrasound histotripsy and immune checkpoint inhibitors (ICIs) to address metastatic or unresectable cancers that have progressed after regular treatment. Researchers will assess the safety, tolerability, and feasibility of the combination treatment in up to 24 participants.
The trial – called iFOCUS (NCT06524570)– is being led by Professor K.P.M. (Karijn) Suijkerbuijk, MD, PhD, an oncologist at University Medical Center (UMC) Utrecht in the Netherlands. The trial focusses on cancer types that generally do not respond to ICIs alone as well as ICI-refractory tumors.
Participants will undergo a single session of histotripsy using Profound Medical’s Sonalleve MR-HIFU device while concurrently receiving an intravenous treatment regimen of the ICIs ipilimumab and nivolumab. Although the primary goals are to assess the therapy’s safety and tolerability, researchers will also examine local tumor responsiveness via follow-up MR and CT scans, immunological responsiveness via biopsy and immunomonitoring in the blood, and progression-free and overall survival.
“We are very excited to have started this trial, which is the first to test the combined treatment in patients,” said Prof. Suijkerbuijk. “Preclinical data suggest that histotripsy and ICI work synergistically and can induce long-term control in cancers that do not respond to immunotherapy alone. This trial will help us determine if the combined treatment is safe and tolerable for cancer patients and will provide preliminary data on its immunological and anti-tumor potential.”
The Sonalleve system obtained the CE Mark in Europe for thermal ablation with high intensity focused ultrasound. It has earned regulatory approvals in various countries to treat desmoid tumors, osteoid osteoma, uterine fibroids, and more. However, this is the first clinical study using the device for histotripsy. Histotripsy is a relatively new method of using focused ultrasound to mechanically liquefy targeted tissue without heat. The lack of heating may be crucial to this study, because when cancerous tissue is heated, the configuration of released antigens can be altered, which can lessen the ability of the immune system to recognize and destroy the cancer cells. The ability to get access to the target without heating could enhance the effectiveness of ICIs.
The iFOCUS trial is designed to pause after treating the first six participants to assess safety outcomes. If cleared, researchers will continue to treat the final cohort. The Focused Ultrasound Foundation is co-funding the treatment of the first six participants in the study.
In January 2021, the Foundation designated UMC Utrecht as a Focused Ultrasound Center of Excellence. It was the fourth site to be designated a Center of Excellence in Europe and the tenth worldwide.
“We congratulate Professor Suijkerbuijk along with the multi-disciplinary team on launching the iFOCUS study based on promising preclinical work in collaboration with the Children’s National Hospital and the National Institutes of Health,” said Chrit Moonen, PhD, the Foundation’s co-director of the Research and Education Team and a former professor in the Division of Imaging at Utrecht. “I was proud to be involved in the initial protocol development of this trial before my retirement, and I am eager to follow the UMC Utrecht team’s progress. The Foundation is proud to support this innovative trial.”
For Patients
If you are interested in learning more about this clinical trial, please contact:
Prof. Suijkerbuijk
+31655234706
k.suijkerbuijk@umcutrecht.nl
Emma J. van Dijk, M.D.
e.j.vandijk-9@umcutrecht.nl