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Adjuvant Tebentafusp in High Risk Ocular Melanoma

Study acronym: ATOM
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Minor Study sites: 14 to 15v14
  2. Minor Study sites: 13 to 14v13
  3. Minor Study sites: 12 to 13v12
  4. Minor Study sites: 11 to 12v11
  5. Minor Study sites: 10 to 11v10
Show 8 earlier versionsHide 8 earlier versions
  1. Minor Study sites: 9 to 10v9
  2. Minor Study sites: 7 to 9v8
  3. Minor Study sites: 6 to 7v7
  4. Minor Study sites: 5 to 6v6
  5. Minor Study sites: 4 to 5v5
  6. Minor Study sites: 2 to 4v4
  7. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    • Start date changed from estimate of Oct 2024 to Nov 11, 2024
    v3
  8. Minor Collaborators: 1 to 2v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
At least 50% of patients with high-risk primary uveal melanoma will develop a recurrence following treatment of the primary tumour. Observation is currently the standard of care in the non-metastatic setting. Tebentafusp is the first agent proven to improve overall survival in patients with metastatic uveal melanoma in a randomized trial. Based on the results in the advanced setting, it is hypothesized that treatment with tebentafusp may reduce the risk of development of disease recurrence.
Trial Details
NCT Number NCT06246149
Lead Sponsor European Organisation for Research and Treatment of Cancer - EORTC
Collaborators: Northwell Health, Immunocore Ltd
Conditions
(from sponsor)
Uveal Melanoma
Related terms Uveal Melanoma
Enrollment 290 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov