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

NCT06627244 | Recruiting Phase 2 DMC FDA Drug FDA Device

• 1 other identifier: 20231324
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Metastatic Uveal Melanoma in the Liver; Metastatic Uveal Melanoma

Outcome Measures

Primary Outcomes (2)

• Progression Free Survival (PFS)

  Progression-free survival (PFS) will be defined as the elapsed time in months from the first date of study treatment until documented disease progression, per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or death from any cause, whichever is earlier. For participants who remain alive without progression, follow-up time will be censored at the date of last disease assessment.

  Up to 24 months

• Number of Participants Experiencing Treatment-Related Adverse Events

  The number of participants experiencing treatment-related adverse events (AEs) and serious adverse events (SAEs) in participants receiving protocol therapy will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5, per physician discretion.

  Up to 24 months

Secondary Outcomes (4)

• Disease control rate (DCR) measured by proportion of patients

  Up to 24 months

• Overall response rate (ORR)

  Up to 2 years

• Duration of response (DOR)

  Up to 24 months

• Overall survival (OS)

  Up to 3 years

Study Arms (1)

Tebentafusp in combination with Radioembolization Group

EXPERIMENTAL

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.

Drug: Tebentafusp; Radiation: TheraSphere™ Yttrium-90 Trans-Arterial Radioembolization

Interventions

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.

Also known as: Y-90 TARE

Tebentafusp in combination with Radioembolization Group

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.

Also known as: Tebentafusp-tebn

Tebentafusp in combination with Radioembolization Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Metastatic uveal melanoma, confined mainly to the liver, and documented by pathology review
• Serum bilirubin \<2 mg/dl, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 5 x upper limit of normal (ULN)
• Mapping angiogram procedure shows radioembolization is feasible and safe to perform
• Human leukocyte antigen-A\*02:01(HLA A⁕ 02:01) positive
• Patient age ≥ 18 years old
• Ability to provide and understand written informed consent
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Patients must have measurable disease or non-measurable disease according to RECIST 1.1 (Eisenhauer et al, 2009).

You may not qualify if:

• Patient with any tumor size \> 8 cm
• Total bilirubin \> 1.5 × ULN, except for patients with Gilbert's syndrome, who are excluded if total bilirubin \> 3.0 × ULN or direct bilirubin \> 1.5 × ULN
• Clinical laboratory measurements that meet any of the following criteria:
• Alanine aminotransferase (ALT) \> 3 × ULN
• Aspartate aminotransferase (AST) \> 3 × ULN
• Absolute neutrophil count (ANC) \< 1.0 × 10\^9 cells/L
• Absolute lymphocyte count \< 0.5 × 10\^9 cells/L
• Platelet count \< 75 × 109 platelets/L
• Hemoglobin \< 8 g/dL
• Angiogram shows vascular shunting which prevents radioembolization
• History of severe hypersensitivity reactions (eg, anaphylaxis) to other biologic drugs or monoclonal antibodies
• Patients with clinically significant cardiac disease or impaired cardiac function, including any of the following:
• Congestive heart failure (New York Heart Association Class ≥ 3).
• Uncontrolled hypertension (consistent findings of systolic blood pressure \[BP\] \> 160 mmHg or diastolic BP \> 110 mmHg).
• History of ventricular arrhythmia currently requiring medical treatment.

Sponsors & Collaborators

• Immunocore Ltd: collaborator
• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

RECRUITING

MeSH Terms

Conditions

Uveal Melanoma

Interventions

tebentafusp

Condition Hierarchy (Ancestors)

Melanoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Uveal Neoplasms; Eye Neoplasms; Neoplasms by Site; Eye Diseases; Uveal Diseases

Study Officials

• Lynn Feun, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lynn Feun, MD

CONTACT

(305) 243-4981; lfeun@med.miami.edu

Benjamin Spieler, MD

CONTACT

(305) 243-4229; bspieler@med.miami.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical

Study Record Dates

• First Submitted: October 2, 2024
• First Posted: October 4, 2024
• Study Start: February 14, 2025
• Primary Completion (Estimated): February 17, 2028
• Study Completion (Estimated): February 17, 2031
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)