Phase II Open-label, Multi-center Study of Tebentafusp in HLA-A*0201 Positive Previously Untreated Metastatic Uveal Melanoma (mUM) With Integrated Circulating Tumor DNA (ctDNA) Biomarker (TARGET-tebe)
Diwakar Davar
Summary
This is a phase II open-label, single-arm, multi-center study of tebentafusp in HLA- A\*0201 positive previously untreated (1L) untreated metastatic uveal melanoma (mUM) with an integrated circulating tumor DNA (ctDNA) biomarker.
Description
Uveal Melanoma (UM) is a rare type of melanoma (3.1% of all melanoma incidence, approximately 4000 cases globally per year) with an incidence of 5.3-10.9 cases per million individuals. Despite its rare incidence rate, UM is the most frequent primary intraocular malignancy of the adult eye that affects the vascular layers of the eye (iris, ciliary body, and choroid). UM has a high incidence of metastases, predominantly to the liver, because of the lack of significant lymphatic traffic out of the eye and predominant hematogenous spread. Tebentafusp has been studied in four clinical studies incl…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Histologically or cytologically confirmed untreated metastatic uveal melanoma (mUM). HLA-A\*0201 genotype positive as assessed using a CLIA-certified blood typing method and confirmed by central review. * If HLA-A status is not known, blood for HLA-A testing must be submitted during Screening, and HLA-A\*0201 positive status confirmed prior to enrollment using a CLIA- certified blood typing method. * If the patient is known to be HLA-A\*0201 positive, this information must be provided in the Screening packet and centrally reviewed by treating PI and Sponsor-Investigator…
Interventions
- DrugTebentafusp
An anti-cancer medication used to treat uveal melanoma. Tebentafusp is a bispecific gp100 peptide-HLA-directed CD3 T cell engager.
Locations (3)
- University of Colorado Cancer CenterAurora, Colorado
- Georgetown University Medical CenterWashington D.C., District of Columbia
- UPMC Hillman Cancer CenterPittsburgh, Pennsylvania