Actively Recruiting
Treatment of Cancer With Immune Checkpoint Inhibition Therapy Boosted by High Intensity Focused Ultrasound Histotripsy
Led by UMC Utrecht · Updated on 2026-02-18
24
Participants Needed
1
Research Sites
313 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Treatment of Cancer With Immune Checkpoint Inhibition Therapy Boosted by High Intensity Focused Ultrasound Histotripsy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed metastatic or unresectable cancer that progressed under standard treatment options
- Age 18 years or older
- Signed and dated informed consent before any study procedure
- Anticipated life expectancy of at least 12 weeks
- At least one tumor lesion suitable for HIFU-HT with specific distance requirements to skin and vulnerable structures
- Tumors not previously treated with radiation or surgery unless showing significant regrowth
- Measurable disease on CT or PET-CT as assessed by investigator and radiology review
- WHO Performance Status 0 or 1
- Screening laboratory values within specified limits (WBC, neutrophils, platelets, hemoglobin, creatinine, liver enzymes, bilirubin)
- Agreement to use effective contraception during the study and for 180 days after last dose
- Willingness to undergo tumor biopsy
- Sufficient proficiency in Dutch to give consent and follow study procedures
You will not qualify if you...
- Known central nervous system, meningeal, or epidural metastatic disease, except stable brain metastases for at least 4 weeks
- Participation in another investigational study or treatment within 4 weeks prior to study treatment
- Prior chemotherapy, targeted therapy, or monoclonal antibodies within 4 weeks before study treatment
- Prior radiotherapy within 8 weeks before study treatment, unless lesion shows massive regrowth
- Prior surgery or ablative therapy within 4 weeks before study treatment
- Ongoing adverse events greater than Grade 1 from previous therapies, except certain exceptions
- History of other malignancies unless adequately treated with expected survival over 5 years
- Medical conditions requiring immunosuppressive medications above specified limits
- Active autoimmune disease requiring systemic treatment in past 2 years
- Active infection requiring systemic therapy
- History or current pneumonitis requiring steroids
- Known active Tuberculosis
- Receipt of live vaccine within 4 weeks before study treatment
- Hypersensitivity to study drugs or their components
- Contraindications to MRI (except certain exceptions)
- Pregnancy or breastfeeding
- Any other medical or social condition that may pose risk or affect study data interpretation
AI-Screening
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Trial Site Locations
Total: 1 location
1
University Medical Center Utrecht
Utrecht, Utrecht, Netherlands
Actively Recruiting
Research Team
K
Karijn P.M. Suijkerbuijk, Prof.
CONTACT
E
Emma J. van Dijk, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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