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Tebentafusp-tebn With LDT in Metastatic UM

StatusRecruiting
PhasePhase 1/2
Started
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Record History

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  1. Study description revisedv8
  2. Site contact updated
    • Collaborators: 1 to 2
    v7
  3. Trial status: Not Yet Recruiting to Recruitingv6 Show 4 more changesShow less
    • Primary completion date: May 2030 to Oct 2030
    • Study completion date: Mar 2032 to Aug 2032
    • Start date changed from estimate of Oct 2025 to Oct 15, 2025
    • Site details revised
  4. Primary completion date: Jan 15, 2027 to May 2030v5 Show 5 more changesShow less
    • Start date: Aug 31, 2025 to Oct 2025
    • Study completion date: Feb 15, 2027 to Mar 2032
    • Secondary endpoints: details revised at 2 of 4 entries
    • Study description expanded, about 602 words
    • Eligibility criteria shortened, about 4 words
  5. Start date: Apr 30, 2025 to Aug 31, 2025
    • Site contact updated
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Primary completion date: Jul 15, 2026 to Jan 15, 2027
    • Start date: Oct 31, 2024 to Apr 30, 2025
    • Study completion date: Aug 15, 2026 to Feb 15, 2027
    v3
  2. Re-verified, no change to tracked fieldsv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 a multicenter, open label phase I/ II trial to assess the safety and clinical efficacy of tebentafusp-tebn in combination with liver-directed therapies in HLA-A\*0201 positive patients with metastatic uveal melanoma. In Part 1 of the study, the Prinicipal Investigator will investigate the safety and efficacy of tebentafusp-tebn in combination with hepatic IE in patients with a low to moderate hepatic disease burden. In Part 2, the study will investigate the efficacy of tebentafusp-tebn in combination with TACE in patients with bulky hepatic disease.
Trial Details
NCT Number NCT06626516
Lead Sponsor Thomas Jefferson University
Collaborators: Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University, Wills Eye
Conditions
(from sponsor)		 Metastatic Uveal Melanoma
Related terms Melanoma, Uveal Melanoma
Enrollment 109 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov