Clinical Trial

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

Study acronym: iFOCUS
Recruiting Phase 1
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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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2024-07-23; most recent amendment 2026-02-13.
Status change: Active, Not Recruiting → Recruiting 2026-02-13
Status change: Recruiting → Active, Not Recruiting 2025-01-05
Status change: Not Yet Recruiting → Recruiting 2024-08-27
Trial Details
NCT Number NCT06524570
Lead Sponsor UMC Utrecht
Conditions Cancer, Metastatic Cancer
Enrollment 24 participants
Start Date 2024-07-26
Primary Completion 2030-08-01 (estimated)
Study Completion 2030-08-01 (estimated)
Updated on ClinicalTrials.gov 2026-02-18