Tebentafusp-tebn With LDT in Metastatic UM (NCT06626516) | Clinical Trial Compass
RecruitingPhase 1/2
Tebentafusp-tebn With LDT in Metastatic UM
United States109 participantsStarted 2025-10-15
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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, immunotherapy, or targeted therapy. They can also have had prior liver directed therapy including surgery, ablation, immunoembolization, or radioembolization. However cannot have had more than two prior lines of treatment total.
✓. 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
✓. Note: Patients with hyperbilirubinemia clinically consistent with an inherited disorder of bilirubin metabolism (e.g., Gilbert syndrome) will be eligible at the discretion of the treating physician and/or the principal investigator.
Exclusion criteria
✕. Parts 1 and 2:
✕. Failure to meet any of the criteria set forth in the Inclusion criteria section
✕. History of prior tebentafusp-tebn use
✕. Prior chemoembolization in Part 2 is not permitted
✕
What they're measuring
1
Part 1A: Safety lead-in
Timeframe: From when the patient receives the first study treatment to 7 days (for non-serious AEs) or 30 days (for SAEs) after completion of study treatment or withdrawal from the study.
2
Part 1A: Efficacy
Timeframe: From when the patient receives the first study treatment to 6 months after first treatment
3
Part 1B: Progression-free Survival
Timeframe: From when patient joins study until disease progression or death, up to 2.5 years after last patient's last treatment.
4
Part 2: 6-month progression-free survival rate
Timeframe: From when the patient receives the first study treatment to 6 months after first treatment.
. History of severe immediate or delayed hypersensitivity reaction to biologic drugs, monoclonal antibodies, iodinated contrast agent
✕. Presence of symptomatic liver failure including ascites and hepatic encephalopathy
✕. Presence of symptomatic or untreated central nervous system (CNS) metastases, or CNS metastases that require corticosteroids within 21 days prior to initiation of study therapy. Patients with brain metastases may be eligible if lesions have been treated with local therapy and there is no evidence of CNS disease progression for at least 4 weeks as measured by MRI prior to first dose of study drug
✕. History of another malignancy except for: 1) those who have been disease-free for 3 years prior to study treatment; 2) patients with a history of completely resected non-melanoma skin cancer; 3) patients with indolent secondary malignancies not requiring active therapy; 4) patients with completely resected carcinoma in situ. Consult the study Principal Investigator if unsure whether second malignancies meet the requirements specified above.