Adjuvant Tebentafusp in High Risk Ocular Melanoma
About this study
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.
- Condition
- Uveal Melanoma
- Tested
- Tebentafusp
- Sponsor
- European Organisation for Research and Treatment of Cancer - EORTC
Who can join
- Age
- 18 years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 18
- Minimum age: 18 years
- Study condition: Uveal Melanoma
- 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
Exclusion 22
- 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.
- 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
Where
15 sites, 15 recruiting
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
and 9 more sites on ClinicalTrials.gov
Contact
-
EORTC HQ
+32 2 774 16 11 eortc@eortc.org
Potential match only. Final eligibility is determined by the study team.