ClinicaliQ Trial Snapshot
- Adjuvant Tebentafusp in High Risk Ocular Melanoma — Recruiting • Phase III • Oncology • NCT06246149.
- Treatment being tested: Tebentafusp (a TCR-engineered T-cell therapy) as adjuvant therapy following primary treatment in patients with high-risk uveal melanoma, aiming to prevent recurrence in the non-metastatic setting where observation is currently standard care.
- Patient eligibility overview: Adults with high-risk primary uveal melanoma who have completed local treatment (surgery/radiotherapy) but have no evidence of metastatic disease; patients must be HLA-A*02:01 positive and have suitable performance status for immunotherapy.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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 Snapshot
- : * 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…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.