OncoMatch/Clinical Trials/NCT06626516
Tebentafusp-tebn With LDT in Metastatic UM
Is NCT06626516 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Tebentafusp-Tebn and GM-CSF (Sargramostim) for metastatic uveal melanoma.
Treatment: Tebentafusp-Tebn · GM-CSF (Sargramostim) · BCNU — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Melanoma
Biomarker criteria
Required: HLA-A A*0201 positive
HLA-A*0201 positive
Disease stage
Required: Stage IV
Metastatic disease required
metastatic uveal melanoma in the liver. Patients must have at least one measurable liver metastasis that is ≥ 10 mm in longest diameter by CT scan or MRI. Tumor Size Criteria: i. Part 1: Total volume of tumor must be < 50% of the liver involvement by CT or MRI; M1a or M1b disease with largest tumor ≤ 5 cm ii. Part 2: M1b disease with largest tumor > 5 cm, M1c disease, or ≥ 50% liver involvement by CT or MRI
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: tebentafusp-tebn (tebentafusp-tebn)
No prior systemic treatment with tebentafusp-tebn
Cannot have received: chemoembolization
Exception: Part 2 only
Prior chemoembolization in Part 2 is not permitted
Lab requirements
Blood counts
Platelet count ≥ 100,000/mm³; Hemoglobin > 8.0g/dL; ANC ≥ 1500
Kidney function
Creatinine clearance > 60mL/min
Liver function
AST and/or ALT < 3x upper limited of normal (ULN); Total bilirubin ≤ 2.0 mg/ml; PT/PTT < 1.5x ULN
Patients must have normal organ and bone marrow function as defined below: Platelet count ≥ 100,000/mm³; Hemoglobin > 8.0g/dL; ANC ≥ 1500; AST and/or ALT < 3x upper limited of normal (ULN); Total bilirubin ≤ 2.0 mg/ml; PT/PTT < 1.5x ULN; Creatinine clearance > 60mL/min; Potassium, magnesium, corrected calcium, and phosphate within normal laboratory parameters
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Thomas Jefferson University · Philadelphia, Pennsylvania
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