EORTC 2022-MG: 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

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-510333-28-00

Acronym

EORTC 2022-MG

Enrollment

200

Registered

2024-09-18

Start date

2025-08-20

Completion date

Unknown

Last updated

2025-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uveal Melanoma

Brief summary

RFS, defined as time between randomization and local recurrence, distant recurrence, or death, whichever occurs first.

Detailed description

OS, defined as time between randomization and death, Safety of tebentafusp.

Interventions

DRUGKIMMTRAK 100 micrograms/0.5 mL concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
RFS, defined as time between randomization and local recurrence, distant recurrence, or death, whichever occurs first.	—

Secondary

Measure	Time frame
OS, defined as time between randomization and death, Safety of tebentafusp.	—

Countries

Belgium, France, Germany, Ireland, Italy, Netherlands, Poland, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026