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

Study acronym: iFOCUS
StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Trial status: Active, Not Recruiting to Recruiting
    • Eligibility criteria expanded, about 44 words
    • Site details revised
    v4
  2. Minor Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v3
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jul 22, 2024 to Jul 26, 2024
    • Site details revised
    v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06524570
Lead Sponsor UMC Utrecht
Conditions
(from sponsor)
Cancer, Metastatic Cancer
Related terms Neoplasm Metastasis, Neoplasms
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov