Actively Recruiting
Phase 2 Single Arm Study of Tebentafusp and Radioembolization for Metastatic Uveal Melanoma
Led by University of Miami · Updated on 2026-02-23
30
Participants Needed
1
Research Sites
156 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
Researchers are evaluating the effects of combining Tebentafusp with Yttrium-90 (Y-90) radioembolization in patients who have metastatic uveal melanoma that has spread to the liver. This Phase 2 study aims to understand both the benefits and risks of this combined treatment approach. The study focuses on patients with liver metastases and includes detailed eligibility assessments based on medical history and tumor characteristics. Participants will first receive Y-90 Trans-Arterial Radioembolization (TARE) to target liver tumors, followed by a recovery period of 14 to 28 days. After recovery, Tebentafusp is administered intravenously once a week in 28-day treatment cycles. The first cycle includes a dose escalation schedule starting with 20 mcg on Day 1, increasing to 30 mcg on Day 8, and then 68 mcg on Day 15. Participants may continue Tebentafusp treatment for up to 24 months or 24 cycles. Total participation in the study lasts about three years. Throughout the study, participants will undergo regular monitoring for disease progression and treatment-related side effects. Researchers will evaluate progression-free survival and adverse events for up to 24 months, along with secondary measures like disease control rate, overall response, duration of response, and overall survival. Safety and response will be closely tracked with clinical assessments, imaging, and laboratory tests. Participants' health status and treatment effects will be observed over the entire study period to gather comprehensive data on this combination therapy.
CONDITIONS
Brief Title
Study of Tebentafusp and Radioembolization in the Treatment of Metastatic Uveal Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosed with metastatic uveal melanoma mainly in the liver, confirmed by pathology
- Serum bilirubin less than 2 mg/dl; AST and ALT less than 5 times the upper limit of normal
- Mapping angiogram confirms that radioembolization is feasible and safe
- Positive for HLA-A*02:01 genetic marker
- Able to provide and understand written informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Have measurable or non-measurable disease as defined by RECIST 1.1 criteria
You will not qualify if you...
- Tumor size larger than 8 cm
- Total bilirubin greater than 1.5 times upper limit of normal (except certain cases of Gilbert's syndrome)
- ALT greater than 3 times upper limit of normal
- AST greater than 3 times upper limit of normal
- 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
- Vascular shunting that prevents radioembolization
- History of severe allergic reactions to biologic drugs or monoclonal antibodies
- Significant heart disease or impaired heart function including congestive heart failure class 3 or higher, uncontrolled high blood pressure, arrhythmias requiring treatment, prolonged QT interval, or recent heart attack
- Symptomatic or untreated brain metastases or brain metastases requiring corticosteroids within 14 days prior to treatment
- Active infection requiring systemic antibiotics within one week prior to treatment
- Known HIV infection
- Active hepatitis B or C infection
- Other malignant diseases except certain treated or indolent cancers
- Any condition that may prevent safe participation or compliance
- Recent use of systemic steroids or immunosuppressive drugs within two weeks before treatment with some exceptions
- Low morning cortisol unless stable adrenal insufficiency
- History of interstitial lung disease or pneumonitis requiring steroids
- Active autoimmune disease requiring immunosuppressive treatment within two years except some controlled conditions
- Major surgery or radiotherapy within two weeks prior to treatment with exceptions
- Recent use of certain colony-stimulating growth factors
- Receiving live or attenuated vaccines within 28 days prior to treatment
- Pregnant or breastfeeding women
- Women of childbearing potential not using highly effective contraception
- Men not using double barrier contraception
- Prior radioembolization or liver-directed therapy to the same site
- Impaired decision-making capacity
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants first undergo Y-90 trans-arterial radioembolization (TARE) followed by a 14 to 28 day recovery period. After recovery, participants receive weekly intravenous Tebentafusp during every 28-day cycle until disease progression, unacceptable toxicity, or withdrawal.
Weekly visits during each 28-day treatment cycle
Duration - Up to 1 year after treatment
Participants are monitored for overall survival and long-term outcomes after completing treatment.
Visits scheduled according to study protocol
Trial Site Locations
Total: 1 location
1
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
Research Team
L
Lynn Feun, MD
B
Benjamin Spieler, MD
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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