Tebentafusp-tebn With LDT in Metastatic UM
ConditionMetastatic Uveal Melanoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorThomas Jefferson University
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
History of severe immediate or delayed hypersensitivity reaction to biologic drugs, monoclonal antibodies, iodinated contrast agent
Trial design
Treatments tested in this trial
- Tebentafusp-Tebn
- GM-CSF (Sargramostim)
- BCNU
Treatment groups
109 Participants
are divided into 4 treatment groupsSponsors and collaborators
Thomas Jefferson University
Lead sponsor
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Collaborator
Wills Eye
Collaborator
Source ClinicalTrials.gov