Neoadjuvant Tebentafusp for Uveal Melanoma

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.

Trial Details

NCT ID
NCT06414590
Phase
PHASE2
Sponsor
Thomas Jefferson University
Status
RECRUITING
Cancer Type
Melanoma
Interventions
  • Tebentafusp-Tebn
Locations (sample)
  • Philadelphia, Pennsylvania, United States|39.95238,-75.16362
  • Philadelphia, Pennsylvania, United States|39.95238,-75.16362

Key Eligibility Criteria

  • 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.

For full eligibility, visit ClinicalTrials.gov.

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