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Hepzato Kit and Opdualag for Metastatic Melanoma and Liver Metastasis

StatusRecruiting
PhasePhase 1/2
Started
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Record History

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  1. Start date pushed from Sep 2026 to Oct 2026
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 3 of 6 entries
    • Study description expanded, about 8 words
  2. Start date: Aug 2026 to Sep 2026v12
  3. Eligibility criteria expanded, about 7 wordsv11
  4. Start date: Jul 2026 to Aug 2026v10
  5. Start date: Jun 2026 to Jul 2026v9
Show 7 earlier versionsHide 7 earlier versions
  1. Start date: May 2026 to Jun 2026v8
  2. Start date: Apr 2026 to May 2026v7
  3. Start date: Mar 2026 to Apr 2026v6
  4. Start date: Feb 2026 to Mar 2026v5
  5. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v4
  6. Start date: Jan 2026 to Feb 2026v3
  7. Start date: Dec 2025 to Jan 2026v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 study is being done to see if combining HEPZATO KIT™ with nivolumab and relatlimab (Opdualag™) in patients with metastatic melanoma with liver metastasis is safe, tolerable, and will have a synergistic effect leading to improved clinical outcomes compared to the historic cohort of patients with liver metastasis treated with combination immune checkpoint inhibitor therapy.
Trial Details
NCT Number NCT07281924
Lead Sponsor University of Wisconsin, Madison
Collaborators: Delcath Systems Inc.
Conditions
(from sponsor)		 Metastatic Melanoma, Liver Metastases
Related terms Melanoma
Enrollment 15 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov