Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Eye Diseases

Rare Diseases

Melanoma

Uveal Neoplasms

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Eye Neoplasms

Uveal Diseases

Ocular Melanoma

Intraocular Melanoma

Neuroendocrine Tumor

Neuroepithelioma

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.

Tebentafusp will be administered weekly i.v.

Tebentafusp

EORTC HQ

Paul Nathan

Richard D. Carvajal

Serge Leyvraz

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.

Adjuvant Tebentafusp in High Risk Ocular Melanoma

Adjuvant Tebentafusp (IMCgp100) Versus Observation in HLA-A*0201 Positive Patients With High-risk Non-metastatic Uveal Melanoma: an EORTC Randomized Phase III Study (ATOM Trial)

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

OS is defined as the time between randomization and death

This study will use the International Common Terminology Criteria for Adverse Events (CTCAE), version 4.0, for adverse event reporting

It will be evaluated using self-administered EORTC QLQ-C30 questionnaire

Northwell Health Cancer Institute

European Organisation for Research and Treatment of Cancer - EORTC

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Adjuvant Tebentafusp in High Risk Ocular Melanoma	NCT06246149	Uveal Melanoma	Tebentafusp	18 Years -	European Organisation for Research and Treatment of Cancer - EORTC
Adjuvant Tebentafusp in High Risk Ocular Melanoma	NCT06246149	Uveal Melanoma	Tebentafusp	18 Years -	European Organisation for Research and Treatment of Cancer - EORTC

Spots Global Cancer Trial Database for randomized phase iii study