Tebentafusp-tebn With LDT in Metastatic UM

This study is a multicenter, open label phase I/ II trial to assess the safety and clinical efficacy of tebentafusp-tebn in combination with liver-directed therapies in HLA-A\*0201 positive patients with metastatic uveal melanoma. In Part 1 of the study, the Prinicipal Investigator will investigate the safety and efficacy of tebentafusp-tebn in combination with hepatic IE in patients with a low to moderate hepatic disease burden. In Part 2, the study will investigate the efficacy of tebentafusp-tebn in combination with TACE in patients with bulky hepatic disease.

Trial Details

NCT ID
NCT06626516
Phase
PHASE1 / PHASE2
Sponsor
Thomas Jefferson University
Status
RECRUITING
Cancer Type
Melanoma
Interventions
  • Tebentafusp-Tebn
  • GM-CSF (Sargramostim)
  • BCNU
Locations (sample)
  • Philadelphia, Pennsylvania, United States|39.95238,-75.16362

Key Eligibility Criteria

  • 1\. Age ≥18 years of age 2. Histologically or cytologically confirmed metastatic uveal melanoma in the liver. Patients must have at least one measu…
  • Prior surgery or ablation for oligometastatic disease is allowable.
  • Palliative radiation of non-target lesions also allowable. ii. Part 2: Patients may have had prior systemic therapy with chemotherapy, immunotherap…
  • 6\. HLA-A\*0201 positive 7. ECOG performance status or 0 or 1 at the time of screening 8. Life expectancy of greater than 3 months as assessed by t…

For full eligibility, visit ClinicalTrials.gov.

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