Study of Tebentafusp and Radioembolization in the Treatment of Metastatic Uveal Melanoma

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT06627244
Phase
PHASE2
Status
Recruiting
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Conditions

  • Metastatic Uveal Melanoma
  • Metastatic Uveal Melanoma in the Liver

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tebentafusp — DRUG
    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.
  • TheraSphere™ Yttrium-90 Trans-Arterial Radioembolization — RADIATION
    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.

Study Details

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.

Key Dates

Start date
Feb 14, 2025
Status verified
Feb 2026
Primary completion
Feb 17, 2028
Completion
Feb 17, 2031

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Tebentafusp in combination with Radioembolization Group
    Participants in this group will first be administered Yttrium 90 Trans-Arterial Radioembolization (Y90 TARE) therapy, followed by a 14 to 28 day recovery period. Participants will then be administered Tebentafusp once weekly during every 28-day cycle. Participants may receive up to 24 months or 24 cycles of Tebentafusp therapy. Total participation is about 3 years.

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: Up to 24 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136
Lynn Feun, MD
[email protected]
(305) 243-4981
Benjamin Spieler, MD
[email protected]
(305) 243-4229
Lynn Feun, MD (PRINCIPAL_INVESTIGATOR)
Benjamin Spieler, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Miami· Miami, FL

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