Neoadjuvant Tebentafusp for Uveal Melanoma (NCT06414590) | Clinical Trial Compass
RecruitingPhase 2
Neoadjuvant Tebentafusp for Uveal Melanoma
United States19 participantsStarted 2025-09-05
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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:
✕. History of severe hypersensitivity reactions (e.g., anaphylaxis) to other biologic drugs or monoclonal antibodies.
What they're measuring
1
Regression of primary uveal melanoma after Tebentafusp treatment in 20% of treated patients.
✕. Clinically significant cardiac disease or impaired cardiac function, including any of the following:
✕. 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: