Neoadjuvant Tebentafusp for Uveal Melanoma

Recruiting now · Phase 2

Conditions studied: Locally Advanced Unresectable Uveal Melanoma

In brief

This is a prospective, single arm, phase II clinical trial of neoadjuvant Tebentafusp (KIMMTRAK®) in patients with locally advanced primary uveal melanoma. Patients must be HLA-A\*02:01 with large, surgically unresectable (other than complete enucleation of the eye) primary uveal melanoma. The efficacy of this treatment will be assessed with the Simon's two stage design. The choice of design is guided by a desire to stop the trial early if the actual regression rate of primary uveal melanoma is 1% or lower.

Key facts

Study ID

NCT06414590

Run by

Thomas Jefferson University

People needed

19

Starts

2025-09-05

Expected to finish

2032-03-01

Last updated by the study team

2026-06-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Individuals must meet all of the following inclusion criteria in order to be eligible to participate in the study:
• Male or female patient age ≥ 18 years of age at the time of informed consent.
• Ability to provide and understand written informed consent prior to any study procedures.
• Willingness to undergo tumor biopsies at baseline and post-Tebentafusp treatment.
• Treatment naïve primary uveal melanoma with T3 or T4 category tumor size that are surgically unresectable (other than complete enucleation of eye).
• No surgical indication to completely remove the tumor without enucleation.
• Clinically or cytologically confirmed primary uveal melanoma.
• Participants must be HLA-A*02:01 positive.
• Predicted life expectancy of at least 12 weeks as estimated by investigator
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening.
• All other relevant medical conditions must be well-managed and stable, in the opinion of the investigator, for at least 28 days prior to first administration of study drug.
• Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.

You may not qualify if…

• An individual who meets any of the following criteria will be excluded from participation in this study:
• Symptomatic uveal melanoma that requires immediate ophthalmological intervention such as enucleation.
• Evidence of metastatic disease.
• Previous treatment with Tebentafusp.
• Patients with any out-of-range laboratory values defined as:
• 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)
• History of severe hypersensitivity reactions (e.g., anaphylaxis) to other biologic drugs or monoclonal antibodies.
• 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
• 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.
• 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:
• Receiving an approved, stable, effective combination antiretroviral therapy regimen for > 3 months prior to the planned first study intervention. NOTE: please review Section 5.7 and consider whether any actions should be taken to minimize potential drug-drug interactions,
• CD4 T cell count > 350 cells/µl,

Where it is running

• Sidney Kimmel Cancer Center at Thomas Jefferson University — Philadelphia, Pennsylvania, United States (enrolling)
• Wills Eye Hospital — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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