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Tebentafusp Regimen Versus Investigator's Choice in Previously Treated Advanced Melanoma (TEBE-AM)

StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Study sites: 72 to 82
    • Eligibility criteria shortened, about 9 words
    v10
  2. Study sites: 66 to 72v9
  3. Eligibility criteria expanded, about 15 wordsv8
  4. Phase: Phase 2/3 to Phase 3v7 Show 8 more changesShow less
    • Primary completion date: Dec 2026 to Mar 2028
    • Primary endpoints: 2 to 1
    • Enrollment target: 460 to 540
    • Study sites: 71 to 66
    • Study completion date: Sep 2027 to Jul 2028
    • Secondary endpoints: 4 to 9
    • Study description expanded, about 17 words
    • Eligibility criteria expanded, about 5 words
  5. Re-verified, no change to tracked fieldsv6
Show 4 earlier versionsHide 4 earlier versions
  1. Study sites: 9 to 71v5
  2. Study sites: 2 to 9
    • Eligibility criteria expanded, about 61 words
    • Secondary endpoints: 9 to 4
    v4
  3. Re-verified, no change to tracked fieldsv3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    • Start date changed from estimate of Nov 2022 to Dec 19, 2022
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Immunocore Ltd
7 trials monitored
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Melanoma
1,092 trials monitored
See 60 trials at risk
The purpose of this study is to evaluate the efficacy and safety of tebentafusp-based regimens, including tebentafusp monotherapy and in combination with anti-PD1 vs investigator choice (including clinical trials of investigational agents, salvage therapy per local standard of care \[SoC\], best supportive care \[BSC\] on protocol survivor follow up) in patients with advanced non-ocular melanoma.
Trial Details
NCT Number NCT05549297
Lead Sponsor Immunocore Ltd
Conditions
(from sponsor)		 Advanced Melanoma
Related terms Melanoma, Nevus, Blue
Enrollment 540 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov