Adjuvant Tebentafusp in High Risk Ocular Melanoma

Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Study ID
NCT06246149
Phase
PHASE3
Status
Recruiting
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Conditions

  • Uveal Melanoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tebentafusp — DRUG
    Tebentafusp will be administered weekly i.v.

Study Details

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.

Key Dates

Start date
Nov 11, 2024
Status verified
Mar 2026
Primary completion
Nov 30, 2032
Completion
Nov 30, 2032

Study Design

Enrollment
290 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tebentafusp
    Participants will receive tebentafusp 20 mcg on week 1, 30 mcg on week 2, 68 mcg on week 3, and 68 mcg weekly thereafter for 6 months i.e., maximum 26 infusions.
  • No Intervention: Observation

Primary Outcome Measure

Recurrence-Free survival (RFS) [ Time Frame: 8.1 years from first patient in ]

Central Contacts

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