Actively Recruiting
Study of Tebentafusp and Radioembolization in the Treatment of Metastatic Uveal Melanoma
Led by University of Miami · Updated on 2026-02-23
30
Participants Needed
1
Research Sites
313 weeks
Total Duration
On this page
Sponsors
U
University of Miami
Lead Sponsor
I
Immunocore Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Study of Tebentafusp and Radioembolization in the Treatment of Metastatic Uveal Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Metastatic uveal melanoma mainly in the liver confirmed by pathology
- Serum bilirubin less than 2 mg/dl; AST and ALT less than 5 times upper limit of normal
- Mapping angiogram shows radioembolization is safe and feasible
- Positive for human leukocyte antigen-A02:01 (HLA A02:01)
- Age 18 years or older
- Ability to give and understand written informed consent
- ECOG performance status of 0 or 1
- Measurable or non-measurable disease by RECIST 1.1 criteria
You will not qualify if you...
- Any tumor larger than 8 cm
- Total bilirubin greater than 1.5 times upper limit of normal (ULN), except Gilbert's syndrome patients excluded if total bilirubin greater than 3.0 times ULN or direct bilirubin greater than 1.5 times ULN
- ALT greater than 3 times ULN
- AST greater than 3 times ULN
- Absolute neutrophil count less than 1.0 x 10^9 cells/L
- Absolute lymphocyte count less than 0.5 x 10^9 cells/L
- Platelet count less than 75 x 10^9 platelets/L
- Hemoglobin less than 8 g/dL
- Angiogram showing vascular shunting that prevents radioembolization
- History of severe allergic reactions to biologic drugs or monoclonal antibodies
- Significant cardiac disease or impaired function including congestive heart failure class 3 or higher, uncontrolled hypertension, ventricular arrhythmia needing treatment, uncontrolled atrial fibrillation, prolonged QTc interval, or recent heart attack or unstable angina
- Symptomatic or untreated central nervous system metastases or requiring corticosteroids within 14 days before treatment
- Active infection needing systemic antibiotics or treatment within 1 week prior to study drug
- Known HIV infection
- Active hepatitis B or C infection
- Other malignancies except certain treated or indolent cancers
- Medical conditions preventing safe participation
- Use of systemic steroids or immunosuppressive drugs within 2 weeks before first dose, except some permitted exceptions
- Morning cortisol below normal unless stable adrenal insufficiency
- History of interstitial lung disease or pneumonitis needing steroids
- Active autoimmune disease requiring immunosuppressive treatment within 2 years, except specified exceptions
- Major surgery within 2 weeks before first dose
- Radiotherapy within 2 weeks before first dose except limited palliative radiotherapy
- Use of hematopoietic growth factors within 3 weeks before first dose, with some exceptions
- Receipt of live or attenuated vaccines within 28 days before first dose
- Pregnant, likely pregnant, or lactating women
- Women of childbearing potential not using highly effective contraception
- Male patients not surgically sterile or not using double barrier contraception
- Prior radioembolization or regional liver-directed therapy to the same liver site
- Impaired decision-making capacity
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
Research Team
L
Lynn Feun, MD
CONTACT
B
Benjamin Spieler, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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