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Adjuvant Tebentafusp in High Risk Ocular Melanoma

NCT06246149 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 290

Last updated 2026-03-04

No results posted yet for this study

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

DRUG

Tebentafusp

Tebentafusp will be administered weekly i.v.

Sponsors & Collaborators

  • Northwell Health

    collaborator OTHER

  • Immunocore Ltd

    collaborator INDUSTRY

  • European Organisation for Research and Treatment of Cancer - EORTC

    lead NETWORK

Principal Investigators

  • Paul Nathan · Mount Vernon Cancer Centre, Northwood, UK

  • Richard D. Carvajal · Northwell Health Cancer Institute, NY, USA

  • Serge Leyvraz · Charité Hospital, Berlin, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-11
Primary Completion
2032-11-30
Completion
2032-11-30

Countries

  • Belgium
  • France
  • Germany
  • Netherlands
  • Poland
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06246149 on ClinicalTrials.gov