Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
290 participants
INTERVENTIONAL
2024-11-11
2032-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Neoadjuvant Tebentafusp for Uveal Melanoma
NCT06414590
Study of Tebentafusp and Radioembolization in the Treatment of Metastatic Uveal Melanoma
NCT06627244
Neoadjuvant Tebentafusp in Patients With Metastatic Uveal Melanoma
NCT07057596
Tebentafusp-tebn With LDT in Metastatic UM
NCT06626516
Tebentafusp Regimen Versus Investigator's Choice in Previously Treated Advanced Melanoma (TEBE-AM)
NCT05549297
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Tebentafusp
Tebentafusp will be administered weekly i.v.
Observation
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Tebentafusp
Tebentafusp will be administered weekly i.v.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* Clinically significant and/or uncontrolled heart disease such as congestive heart failure (New York Heart Association grade ≥ 2), uncontrolled hypertension, or clinically significant arrhythmia currently requiring medical treatment
* QTcF \> 470 msec on screening electrocardiogram (ECG) or congenital long QT syndrome based on at least 3 ECGs obtained over a brief time interval (i.e., within 30 minutes)
* Acute myocardial infarction or unstable angina pectoris \< 6 months prior to screening
* Active infection requiring systemic antibiotic therapy. Patients requiring systemic antibiotics for infection must have completed therapy at least 1 week prior to randomization
* Any evidence of severe or uncontrolled systemic disease or active infection including hepatitis B, hepatitis C and known active human immunodeficiency virus (HIV) defined as \>200 copies of HIV per ml of blood, active bleeding diatheses or renal transplant. NOTE: testing for HIV, HBV, and HCV status prior to enrolment is not necessary unless clinically indicated.
* Participant with history of HBV infection will be eligible if on stable anti-viral therapy for \> 4 weeks prior to the planned first dose of study intervention and viral load confirmed as undetectable during Screening.
* Participant with history of HBC infection will be eligible the participant has received curative treatment and viral load was confirmed as undetectable during Screening.
* History of another primary malignancy except for adequately treated basal or squamous cell carcinoma of the skin or cancer of the cervix in situ and with the following exception. Patients with a history of another primary cancer treated with curative intent more than 3 years before study entry, who are not receiving any anti-cancer therapy, have a risk of disease recurrence lower than 10% as evaluated by the local Investigator, and who have no toxicity from previous treatment are eligible.
* Participants with active autoimmune disease requiring immunosuppressive treatment, including inflammatory bowel disease (ulcerative colitis or Crohn's disease), within 2 years of screening. NOTE: The following exceptions are permitted:
* Vitiligo
* Alopecia
* Managed hypothyroidism (on stable replacement doses)
* Asymptomatic adrenal insufficiency (on stable replacement doses)
* Psoriasis
* Resolved childhood asthma/atopy
* Well-controlled asthma
* Type I diabetes mellitus
* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed and discussed with the patient before the enrolment in the trial.
* Known contraindication to imaging tracer or any product of contrast media and MRI and/or CT contraindications
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Northwell Health
OTHER
Immunocore Ltd
INDUSTRY
European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Paul Nathan
Role: PRINCIPAL_INVESTIGATOR
Mount Vernon Cancer Centre, Northwood, UK
Richard D. Carvajal
Role: PRINCIPAL_INVESTIGATOR
Northwell Health Cancer Institute, NY, USA
Serge Leyvraz
Role: PRINCIPAL_INVESTIGATOR
Charité Hospital, Berlin, Germany
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
Centre Antoine Lacassagne
Nice, , France
Institut Curie - Hôpital de Paris
Paris, , France
Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin
Berlin, , Germany
Universitaets Krankenhaus Eppendorf - Universitaetsklinikum Hamburg-Eppendorf KE - University Cancer Center
Hamburg, , Germany
Universitaetsklinikum Heidelberg - Frauenklinik / Hautklinik
Heidelberg, , Germany
Leiden University Medical Centre
Leiden, , Netherlands
Maria Sklodowska-Curie Memorial Cancer Centre - Maria Sklodowska-Curie National Research Institute of Oncology
Warsaw, , Poland
Institut Catala d'Oncologia - ICO L'Hospitalet - Hospital Duran i Reynals (Institut Catala D'Oncologia)
L'Hospitalet de Llobregat, , Spain
Hospital Clinico Universitario De Valladolid
Valladolid, , Spain
The Clatterbridge cancer Center NHS foundation Trust - Clatterbridge Cancer Center - Liverpool
Liverpool, , United Kingdom
East and North Hertfordshire NHS Trust - Mount Vernon Hospital
Northwood, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Jean-Francois Baurain
Role: primary
Agnes Ducoulombier
Role: primary
Manuel Rodrigues
Role: primary
Caroline Anna Peuker
Role: primary
Christoffer Gebhardt
Role: primary
Ellen Kapiteijn
Role: primary
Piotr Rutkowski
Role: primary
Josep Piulats Rodriguez
Role: primary
Lopez Castro Rafael
Role: primary
Joseph Sacco
Role: primary
Paul Nathan, Pr
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EU trial number
Identifier Type: OTHER
Identifier Source: secondary_id
EORTC-2022-MG
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.