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Studying Tebentafusp for Unresectable Uveal Melanoma

This study is testing a drug called Tebentafusp (KIMMTRAK®) for people with locally advanced uveal melanoma (a type of eye cancer) that cannot be removed by surgery. Researchers want to see if Tebentafusp can shrink these tumors before other treatments. You might be able to join if you are 18 or older and have this specific type of melanoma. The study will measure success by seeing if the tumor shrinks by at least 20% after 3 months of treatment. This is a small study, planning to enroll 19 participants. The current status of the study is unclear.

Study design
This is a single-arm, Phase II clinical trial, meaning all 19 participants will receive the same treatment. It is an investigator-initiated study.
What's involved
You would need to provide informed consent, undergo tumor biopsies before and after Tebentafusp treatment, and have regular eye exams and imaging (ultrasound, OCT). Blood and fluid samples from the eye will also be collected.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome of tumor regression is measured at 3 months after eye treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06414590

Neoadjuvant Tebentafusp for Uveal Melanoma

Recruiting
PHASE2Ages 18+InterventionalTreatment
Thomas Jefferson University
~19 participants
Updated 2026-06-12 on ClinicalTrials.gov
What's tested:Tebentafusp-Tebn

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Regression of primary uveal melanoma after Tebentafusp treatment in 20% of treated patients.
Measured over 3 months post-eye treatment

Conditions

Locally Advanced Unresectable Uveal Melanoma

Explore related trials

Uveal MelanomaHLA Class I Histocompatibility Antigen, A-0201 Alpha Chain

Where it's being run

2 sites across 1 states
Pennsylvania2

Study leadership

  • Rino Seedor, MD · PRINCIPAL_INVESTIGATOR · Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Who to contact

Rino Seedor, MD
[email protected]
215-955-8874
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Exclusion

Serum creatinine \> 1.5 x upper limit of normal (ULN) and/or creatinine clearance (calculated using Cockcroft-Gault Formula, or measured) \< 50 mL/minute
Albumin \< 3.0 g/dl
Total bilirubin \>1.5 mg/dL (or 1.3 x ULN). Patients with hyperbilirubinemia clinically consistent with an inherited disorder of bilirubin metabolism (e.g., Gilbert syndrome) will be eligible at the discretion of the treating physician and/or the principal investigator.
Alanine aminotransferase \> 1.5 x ULN
Aspartate aminotransferase \> 1.5 x ULN
Absolute neutrophil count \< 1.0 x 109 /L
Absolute lymphocyte count \< 0.5 x 109 /L
Platelet count \< 100 x 109 /L
Hemoglobin \< 9.0 g/dL
Uncorrectable abnormal potassium, magnesium, corrected calcium or phosphate abnormality of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0) \> grade 1
Morning cortisol \< lower limit of normal (unless the patient has asymptomatic adrenal insufficiency and is receiving stable replacement doses) 5. History of severe hypersensitivity reactions (e.g., anaphylaxis) to other biologic drugs or monoclonal antibodies. 6. Clinically significant cardiac disease or impaired cardiac function, including any of the following:
Left Ventricular Ejection Fraction \<50%
Clinically significant and/or uncontrolled heart disease such as congestive heart failure (New York Heart Association grade ≥ 2), uncontrolled hypertension, or clinically significant arrhythmia uncontrolled with medical treatment
Acute myocardial infarction or unstable angina pectoris \< 6 months to Screening 7. Active infection requiring systemic antibiotic therapy. Patients requiring systemic antibiotics for infection must have completed therapy at least 1 week prior to the first dose of study drug. 8. Participants with a history of human immunodeficiency virus (HIV) infection. NOTE: Testing is not required unless mandated by the local health authority. Participants with HIV infection may be eligible if ALL of the following are applicable:

What this trial measures

  • Regression of primary uveal melanoma after Tebentafusp treatment in 20% of treated patients.3 months post-eye treatment

    Regression is defined as ≥ 20% reduction in tumor volume. All estimates of rates will be presented with corresponding 95% exact confidence intervals. For regression rate, the method of Atkinson and Brown will be used to allow for the two-stage design.