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New treatment option for Uveal Melanoma
Official title Adjuvant Tebentafusp in High Risk Ocular Melanoma
ClinicalTrials.gov ID: NCT06246149
What this study is testing
What is Tebentafusp?
Tebentafusp is an investigational medicine, given as an once-weekly, being studied as a potential treatment for uveal melanoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- ECOG performance status of 0 or 1
- 18 years or older
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...
- QTcF \> 470 msec on screening electrocardiogram (ECG) or congenital long QT syndrome based on at least 3 ECGs obtained over a brief time interval...
- 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...
- Any evidence of severe or uncontrolled systemic disease or active infection including hepatitis B, hepatitis C and known active human...
See the full eligibility criteria
- 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...
- 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...
- For female people 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
- 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...
- 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...
- 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...
- 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...
- 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...
- 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
- Lake Success, New York, United States
- Brussels, Belgium
- Nice, France
- Paris, France
- Berlin, Germany
- Hamburg, Germany
- Heidelberg, Germany
- Leiden, Netherlands
- Rotterdam, Netherlands
- Warsaw, Poland
- L'Hospitalet de Llobregat, Spain
- Valladolid, Spain
- Gothenburg, Sweden
- Liverpool, United Kingdom
- Northwood, 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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lake Success, New York, United States; Brussels, Belgium; Nice, France; Paris, France; Berlin, Germany; Hamburg, Germany and 9 more location(s). 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 ClinicalTrials.gov; the study team decides eligibility.