Neoadjuvant Tebentafusp for Uveal Melanoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorThomas Jefferson University
About this trial
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.
Eligibility criteria
Qualifiers
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).
Disqualifiers
Symptomatic uveal melanoma that requires immediate ophthalmological intervention such as enucleation.
Evidence of metastatic disease.
Previous treatment with Tebentafusp.
Serum creatinine > 1.5 x upper limit of normal (ULN) and/or creatinine clearance (calculated using Cockcroft-Gault Formula, or measured) < 50 mL/minute
Trial design
Treatments tested in this trial
- Tebentafusp-Tebn
Treatment groups
19 Participants
are divided into 1 treatment groupSponsors and collaborators
Thomas Jefferson University
Lead sponsor
Immunocore Ltd
Collaborator
Source ClinicalTrials.gov