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Neoadjuvant Tebentafusp for Uveal Melanoma

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Eligibility criteria shortened, about 21 words
    • Study description shortened, about 6 words
    v9
  2. Eligibility criteria expanded, about 298 words
    • Study description expanded, about 198 words
    • Collaborators expanded, about 2 words
    v8
  3. Study description shortened, about 1 wordv7
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 2
    • Start date changed from estimate of Sep 2025 to Sep 5, 2025
    • Study description expanded, about 81 words
    v6
  5. Primary completion date: Jan 2026 to Aug 2027
    • Start date: Apr 2025 to Sep 2025
    • Study completion date: Jul 2029 to Mar 2032
    • Study description expanded, about 17 words
    v5
Show 3 earlier versionsHide 3 earlier versions
  1. Start date: Jan 2025 to Apr 2025
    • Primary completion date: Oct 2025 to Jan 2026
    • Study completion date: Apr 2029 to Jul 2029
    v4
  2. Start date: Sep 2024 to Jan 2025
    • Primary completion date: Jun 2025 to Oct 2025
    • Study completion date: Dec 2028 to Apr 2029
    v3
  3. Start date: Jul 2024 to Sep 2024
    • Primary completion date: Apr 2025 to Jun 2025
    • Study completion date: Oct 2028 to Dec 2028
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 is a prospective, single arm, phase II clinical trial of neoadjuvant Tebentafusp (KIMMTRAK®) in patients with locally advanced primary uveal melanoma. Patients must be HLA-A\*02:01 with large, surgically unresectable (other than complete enucleation of the eye) primary uveal melanoma. The efficacy of this treatment will be assessed with the Simon's two stage design. The choice of design is guided by a desire to stop the trial early if the actual regression rate of primary uveal melanoma is 1% or lower.
Trial Details
NCT Number NCT06414590
Lead Sponsor Thomas Jefferson University
Collaborators: Immunocore Ltd
Conditions
(from sponsor)		 Locally Advanced Unresectable Uveal Melanoma
Related terms Uveal Melanoma
Enrollment 19 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov