Trials / Recruiting
RecruitingNCT06627244
Study of Tebentafusp and Radioembolization in the Treatment of Metastatic Uveal Melanoma
Phase 2, Single Arm Study of Tebentafusp and Radioembolization in the Treatment of Metastatic Uveal Melanoma
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- University of Miami · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine the effects (good and bad) that Tebentafusp in combination with Yttrium-90 (Y-90) radioembolization has on patients with metastatic uveal melanoma that has spread to the liver.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tebentafusp | Tebentafusp will be administered intravenously to participants at or within 28 days of their first Y-90 TARE procedure. This 28-day period includes the 14- to 28-day Y-90 TARE Recovery Period. For administrative purposes, one cycle of tebentafusp treatment is 28 days in length. Tebentafusp will be administered on a dose escalation schedule for Cycle 1 starting at 20 mcg on Day 1, increasing to 30 mcg on Day 8, and a final dose of 68 mcg on Day 15, which will be administered once per week until unacceptable toxicity develops, disease progression, or withdrawal of consent, whichever occurs first. |
| RADIATION | TheraSphere™ Yttrium-90 Trans-Arterial Radioembolization | Participants will undergo radiographic and 99mTC-labeled macroaggregated albumin (99mTc-MAA) assessment for suitability prior to Y-90 absorbed glass microsphere treatment per institutional procedures. Y-90 trans-arterial radioembolization (TARE) is a standard of care treatment for intrahepatic metastases of uveal melanoma as indicated in the National Comprehensive Cancer Network (NCCN) consensus guidelines (NCCN Guidelines®, 2023). Y-90 absorbed glass microspheres will be administered at least one time prior to initiating Tebentafusp treatment. After the Y90-TARE procedure, participants will have a 14- to 28-day Y-90 TARE Recovery Period. |
Timeline
- Start date
- 2025-02-14
- Primary completion
- 2028-02-17
- Completion
- 2031-02-17
- First posted
- 2024-10-04
- Last updated
- 2026-02-23
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06627244. Inclusion in this directory is not an endorsement.