OncoMatch/Clinical Trials/NCT06524570
Treatment of Cancer With Immune Checkpoint Inhibition Therapy Boosted by High Intensity Focused Ultrasound Histotripsy
Is NCT06524570 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including HIFU-HT and ICI for cancer.
Treatment: HIFU-HT · ICI — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Disease stage
Metastatic disease required
Performance status
WHO 0–1
Prior therapy
Must have received: standard of care treatment
cancer that progressed under standard of care treatment options
Cannot have received: chemotherapy
Prior chemotherapy within 4 weeks prior to the first dose of the study treatment
Cannot have received: targeted small molecule therapy
Prior targeted small molecule therapy within 4 weeks prior to the first dose of the study treatment
Cannot have received: monoclonal antibody
Prior monoclonal antibodies within 4 weeks prior to the first dose of the study treatment
Cannot have received: radiation therapy
Exception: lesions that showed massive regrowth
Prior radiotherapy within 8 weeks prior to the first dose of the study treatment. The patient will be excluded from the study if the only targetable lesion has directly been treated with radiation therapy in the past with an exception for lesions that showed massive regrowth.
Cannot have received: surgery
Prior surgery within 4 weeks prior to the first dose of the study treatment
Cannot have received: ablative therapy
Prior ablative therapy within 4 weeks prior to the first dose of the study treatment. The patient will be excluded from the study if the only targetable lesion has directly been treated with ablative therapy in the past.
Lab requirements
Blood counts
WBC ≥ 2.0x10^9/L; Neutrophils ≥1.5x10^9/L; Platelets ≥100 x10^9/L; Hemoglobin ≥5.5 mmol/L
Kidney function
Serum creatinine ≤1.5 x ULN or calculated creatinine clearance ≥60 mL/minute (≤Grade 1)
Liver function
AST ≤2.5 x ULN; ALT ≤2.5 x ULN; AST/ALT <5 x ULN if liver involvement; Serum bilirubin ≤1.5 x ULN or direct bilirubin ≤ULN for subjects with total bilirubin levels >1.5xULN, except in subjects with Gilbert's Syndrome
Screening laboratory values must meet the following criteria: WBC ≥ 2.0x10^9/L, Neutrophils ≥1.5x10^9/L, Platelets ≥100 x10^9/L, Hemoglobin ≥5.5 mmol/L, Serum creatinine ≤1.5 x ULN or calculated creatinine clearance ≥60 mL/minute (≤Grade 1), AST ≤2.5 x ULN; ALT ≤2.5 x ULN; AST/ALT <5 x ULN if liver involvement, Serum bilirubin ≤1.5 x ULN or direct bilirubin ≤ULN for subjects with total bilirubin levels >1.5xULN, except in subjects with Gilbert's Syndrome
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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