Actively Recruiting
Tebentafusp-tebn With LDT in Metastatic UM
Led by Thomas Jefferson University · Updated on 2025-11-28
109
Participants Needed
1
Research Sites
354 weeks
Total Duration
On this page
Sponsors
T
Thomas Jefferson University
Lead Sponsor
S
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is a multicenter, open label phase I/ II trial to assess the safety and clinical efficacy of tebentafusp-tebn in combination with liver-directed therapies in HLA-A\*0201 positive patients with metastatic uveal melanoma. In Part 1 of the study, the Prinicipal Investigator will investigate the safety and efficacy of tebentafusp-tebn in combination with hepatic IE in patients with a low to moderate hepatic disease burden. In Part 2, the study will investigate the efficacy of tebentafusp-tebn in combination with TACE in patients with bulky hepatic disease.
CONDITIONS
Official Title
Tebentafusp-tebn With LDT in Metastatic UM
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically or cytologically confirmed metastatic uveal melanoma in the liver
- At least one measurable liver metastasis 10 mm or larger by CT or MRI
- For Part 1: Tumor volume less than 50% of liver involvement; largest tumor 5 cm or smaller
- For Part 2: Largest tumor greater than 5 cm, or 50% or more liver involvement
- No prior systemic treatment with tebentafusp-tebn
- For Part 1: Treatment-naive in metastatic setting; prior surgery or ablation for oligometastatic disease allowed; palliative radiation to non-target lesions allowed
- For Part 2: Prior systemic therapy or liver-directed therapy allowed, but no more than two prior lines of treatment total
- HLA-A*0201 positive
- ECOG performance status 0 or 1 at screening
- Life expectancy greater than 3 months
- Normal organ and bone marrow function as defined (including platelet count, hemoglobin, ANC, liver enzymes, bilirubin, clotting times, creatinine clearance, electrolytes)
- Women must not be pregnant or breastfeeding
- Women of child-bearing potential and men must agree to use contraception during and 6 months after study
- Male patients must be surgically sterile or use double barrier contraception during and 6 months after study
- Ability to understand and willingness to sign informed consent
You will not qualify if you...
- Does not meet all inclusion criteria
- Prior use of tebentafusp-tebn
- Prior chemoembolization in Part 2
- History of severe immediate or delayed hypersensitivity to biologic drugs, monoclonal antibodies, or iodinated contrast agents
- Symptomatic liver failure including ascites and hepatic encephalopathy
- Symptomatic or untreated central nervous system metastases, or CNS metastases requiring corticosteroids within 21 days before treatment
- Brain metastases with disease progression within 4 weeks prior to first dose
- History of another malignancy unless disease-free for at least 3 years or specific exceptions apply
- Major surgery within 2 weeks before first dose (excluding minor procedures)
- Radiotherapy within 2 weeks before first dose except limited palliative radiation
- Toxicities greater than Grade 1 from prior therapies except stable immune-related endocrinopathies
- Use of investigational drugs within 28 days before first dose
- Use of hematopoietic colony-stimulating growth factors within 14 days before treatment
- Known HIV infection
- Active hepatitis B or C infection
- Receiving systemic steroids or immunosuppressive medications (local steroids allowed)
- History of bleeding disorders
- Pregnant, likely to become pregnant, or breastfeeding
- Uncontrolled concurrent illness
- Biliary obstruction, biliary stent, prior biliary surgery except cholecystectomy, or anatomical issues interfering with treatments
- Occlusion of the main portal vein or inadequate collateral flow
- Arteriovenous shunt in hepatic artery
- Any medical condition preventing safe participation
- For Part 1 only: History of severe hypersensitivity to GM-CSF
AI-Screening
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Trial Site Locations
Total: 1 location
1
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
Research Team
R
Rino Seedor, MD
CONTACT
C
Carolyn Palumbo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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