Trials / Recruiting
RecruitingNCT06246149
Adjuvant Tebentafusp in High Risk Ocular Melanoma
Adjuvant Tebentafusp (IMCgp100) Versus Observation in HLA-A*02:01 Positive Patients Following Definitive Treatment of High-risk Uveal Melanoma: an EORTC Randomized Phase III Study (ATOM Trial)
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 290 (estimated)
- Sponsor
- European Organisation for Research and Treatment of Cancer - EORTC · Network
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tebentafusp | Tebentafusp will be administered weekly i.v. |
Timeline
- Start date
- 2024-11-11
- Primary completion
- 2032-11-01
- Completion
- 2032-11-01
- First posted
- 2024-02-07
- Last updated
- 2026-03-04
Locations
14 sites across 8 countries: Belgium, France, Germany, Netherlands, Poland, Spain, Sweden, United Kingdom
Source: ClinicalTrials.gov record NCT06246149. Inclusion in this directory is not an endorsement.