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
Location: See all (9) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Primary non-metastatic UM, except iris melanoma, after definitive treatment either by surgery or radiotherapy

• Time from primary treatment smaller than 11 weeks (note that the maximum time between primary treatment and randomization is 12 weeks )

• High-risk according to either 1) clinical criteria: TNM (AJCC8) stage III or 2) genetic criteria: monosomy 3 or GEP class 2. Prior to enrolment of the first patient, each site will declare which of the two genetic criteria it uses. Patients with stage I and stage II are only eligible if they meet the genetic criterion declared by the site.

• ECOG performance status of 0 or 1

• 18 years or older

• HLA-A\*02:01 positivity by local assessment

• No evidence of UM recurrence, as evidenced by the required baseline imaging performed within 4 weeks prior to randomization

• Adequate organ function

• Time-interval between the end of primary treatment and the randomization less than or equal to 12 weeks

• Evidence of post-menopausal status or negative urinary or serum pregnancy test for women of childbearing potential (WOCBP) within 3 days prior to randomization.

• For patients of childbearing / reproductive potential, agreement to use adequate birth control measures during the study treatment period and for at least 6 months after the last dose of treatment. A highly effective method of birth control is defined as a method which results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly.

• For female subjects who are breast feeding, agreement to discontinue nursing prior to the first dose of study treatment and until 6 months after the last study treatment.

• Written informed consent according to ICH/GCP and local regulations

Locations
Other Locations
Belgium
Cliniques Universitaires Saint-Luc
RECRUITING
Brussels
France
Institut Curie - Hôpital de Paris
RECRUITING
Paris
Germany
Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin
RECRUITING
Berlin
Universitaets Krankenhaus Eppendorf - Universitaetsklinikum Hamburg-Eppendorf KE - University Cancer Center
RECRUITING
Hamburg
Universitaetsklinikum Heidelberg - Frauenklinik / Hautklinik
RECRUITING
Heidelberg
Netherlands
Leiden University Medical Centre
RECRUITING
Leiden
Poland
Maria Sklodowska-Curie Memorial Cancer Centre - Maria Sklodowska-Curie National Research Institute of Oncology
RECRUITING
Warsaw
Spain
Institut Catala d'Oncologia - ICO L'Hospitalet - Hospital Duran i Reynals (Institut Catala D'Oncologia)
RECRUITING
L'hospitalet De Llobregat
Hospital Clinico Universitario De Valladolid
RECRUITING
Valladolid
Contact Information
Primary
EORTC HQ
eortc@eortc.org
+32 2 774 16 11
Time Frame
Start Date: 2024-11-11
Estimated Completion Date: 2032-11
Participants
Target number of participants: 290
Treatments
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
Sponsors
Leads: European Organisation for Research and Treatment of Cancer - EORTC
Collaborators: Northwell Health, Immunocore Ltd

This content was sourced from clinicaltrials.gov