Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06414590 | Neoadjuvant Tebentafusp for Uveal Melanoma | PHASE2 | RECRUITING | 19 | — | — | Sep 5, 2025 | Mar 1, 2032 | Apr 14, 2026 | 2 | United States |
Regression is defined as ≥ 20% reduction in tumor volume. All estimates of rates will be presented with corresponding 95% exact confidence intervals. For regression rate, the method of Atkinson and Brown will be used to allow for the two-stage design.
| Arm | Type | Description |
|---|---|---|
| Neoadjuvant Tebentafusp in Patients Locally Advanced, Unresectable Primary Uveal Melanoma | EXPERIMENTAL | Tebentafusp administration: 20mcg on Day 1, 30mcg on Day 8, 68 mcg on Day 15, and weekly doses of 68 mcg thereafter. Eye evaluations including clinical examination, ophthalmic ultrasound, optical coherence tomography, and wide-angle fundus imaging will be performed at baseline, Cycle 1 day 1, Cycle 1 day 8, Cycle 2 day 1, prior to definitive treatment for primary uveal melanoma (post-Tebentafusp), and at post-eye treatment evaluation at 3 months. Additionally optical coherence tomography angiography, autofluorescence, fluorescein angiography and MRI orbit will be performed at baseline, post-tebentafusp, and at post-eye treatment evaluation. Blood circulating tumor-derived DNA will be performed at baseline, Cycle 2 day 1, post-Tebentafusp, and at post-eye treatment evaluation at 3 months. Primary eye tumor biopsy (collected by fine-needle aspiration) and aqueous circulating tumor-derived DNA will be performed at baseline and post-Tebentafusp. |
| Name | Type | Description |
|---|---|---|
| Tebentafusp-Tebn | DRUG | Tebentafusp will be administered as follows: 20mcg on Day 1, 30mcg on Day 8, 68 mcg on Day 15, and weekly doses of 68 mcg thereafter. |
Inclusion Criteria: Individuals must meet all of the following inclusion criteria in order to be eligible to participate in the study: 1. Male or female patient age ≥ 18 years of age at the time of informed consent. 2. Ability to provide and understand written informed consent prior to any study p...