NCT06524570

Treatment of Cancer With Immune Checkpoint Inhibition Therapy Boosted by High Intensity Focused Ultrasound Histotripsy

Treatment of Cancer With Immune Checkpoint Inhibition Therapy Boosted by High Intensity Focused Ultrasound Histotripsy; the iFOCUS Study

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: UMC Utrecht · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase 1 clinical trial aims to evaluate the safety, tolerability and feasibility of combination treatment of High Intensity Focused Ultrasound Histotripsy (HIFU-HT) and immune checkpoint inhibitors (ICI) in adult patients with metastatic or unresectable cancer that have progressive disease after regular treatment. Patients will undergo one single session of HIFU-HT during treatment with ipilimumab and nivolumab. Safety, tolerability and feasibility endpoints will be studied as well as radiologic, immunologic and clinical response.

Conditions

• Cancer
• Metastatic Cancer

Interventions

Type	Name	Description
DEVICE	HIFU-HT	High-Intensify Focused Ultrasound Histotripsy
DRUG	ICI	Ipilimumab and nivolumab

Timeline

• Start date: 2024-07-26
• Primary completion: 2030-08-01
• Completion: 2030-08-01
• First posted: 2024-07-29
• Last updated: 2026-02-18

Locations

1 site across 1 country: Netherlands