OncoMatch/Clinical Trials/NCT06626516
Tebentafusp-tebn With LDT in Metastatic UM
Is NCT06626516 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
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
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06626516 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior tebentafusp-tebn, chemoembolization disqualifies patients from enrollment.
Does this trial require HLA-A?
Yes, HLA-A A*0201 positive is a required biomarker for enrollment.
What disease stage is eligible?
Stage IV is required (metastatic disease required).
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages