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EORTC 2022-MG: Treatment with tebentafusp or observation for patients with melanoma of the eye after surgery or radiation (ATOM Trial)
EU CTIS ID: 2023-510333-28-00
What this study is testing
To prospectively assess whether adjuvant treatment with tebentafusp improves recurrence-free survival (RFS) as compared to observation.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Pre-screening: Primary non-metastatic UM, except iris melanoma, after definitive treatment either by surgery or radiotherapy
- Screening: Time-interval between the end of primary treatment and the randomization less than or equal to 12 weeks
- Screening: Evidence of post-menopausal status or negative urinary or serum pregnancy test for women of childbearing potential (WOCBP) within 3 days prior to randomization.
- Screening: 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.
- Screening: 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.
- Screening: Written informed consent according to ICH/GCP and local regulations
You likely can't join if
- Clinically significant cardiac disease or impaired cardiac function, including any of the following: • 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. • 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
See the full eligibility criteria
Who can join
- Pre-screening: Primary non-metastatic UM, except iris melanoma, after definitive treatment either by surgery or radiotherapy
- Screening: Time-interval between the end of primary treatment and the randomization less than or equal to 12 weeks
- Screening: Evidence of post-menopausal status or negative urinary or serum pregnancy test for women of childbearing potential (WOCBP) within 3 days prior to randomization.
- Screening: 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.
- Screening: 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.
- Screening: Written informed consent according to ICH/GCP and local regulations
- Pre-screening: Time from primary treatment smaller than 11 weeks (note that the maximum time between primary treatment and randomization is 12 weeks)
- Pre-screening: 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
- Pre-screening: ECOG performance status of 0 or 1
- Pre-screening: 18 years or older
- Pre-screening: Written pre-screening informed consent according to ICH/GCP and local regulations
- Screening: HLA-A*02:01 positivity by local assessment
- Screening: No evidence of UM recurrence, as evidenced by the required baseline imaging performed within 4 weeks prior to randomization
- Screening: Adequate organ function:• Serum creatinine ≤ 1.5 × ULN and/or creatinine clearance (calculated using Cockcroft-Gault formula, or measured) ≥ 40 mL/minute • Total bilirubin ≤ 1.5 × ULN, except for patients with Gilbert's syndrome who are excluded if total bilirubin > 3.0 × ULN or direct bilirubin ≥1.5 × ULN • Alanine aminotransferase ≤ 3 × ULN • Aspartate aminotransferase ≤ 3 × ULN • Absolute neutrophil count ≥ 1.0 × 10^9/L • Absolute lymphocyte count ≥ 0.5 × 10^9/L • Platelet count ≥ 150 × 10^9/L • Haemoglobin ≥ 10 g/dL
What rules you out
- Clinically significant cardiac disease or impaired cardiac function, including any of the following: • 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. • 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.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.