drugset / Trial / NCT06626516
Tebentafusp-tebn With LDT in Metastatic UM
Phase 1/2
Recruiting
109 enrolled
Thomas Jefferson University
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University · collabWills Eye · collab
RandomizedSequentialOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2025-10-15
- Primary completion
- 2030-10
- Completion
- 2032-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tebentafusp | Protein / enzyme biologic | 68 ug | — |
| Comparator | carmustine | Small molecule | 300 mg | Other |
| Subject | sargramostim | Protein / enzyme biologic | 1500 mg | Other |