Tebentafusp in HLA-A*0201 Positive Previously Untreated Metastatic Uveal Melanoma

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Diwakar Davar
Study ID
NCT06070012
Phase
PHASE2
Status
Recruiting
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Conditions

  • Uveal Melanoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tebentafusp — DRUG
    An anti-cancer medication used to treat uveal melanoma. Tebentafusp is a bispecific gp100 peptide-HLA-directed CD3 T cell engager.

Study Details

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.

Key Dates

Start date
Aug 18, 2025
Status verified
Feb 2026
Primary completion
Sep 30, 2028
Completion
Sep 30, 2030

Study Design

Enrollment
44 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Tebentafusp (IMCgp100)
    Dose: 20mcg W1D; 30mcg W2D1; 68mcg W3D1and subsequent doses Frequency: Weekly on D1 of 12-week cycles

Primary Outcome Measure

Change in ctDNA response [ Time Frame: At Baseline, at Week 10 of each 12-week cycle, Up to 24 months] ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of Colorado Cancer CenterAuroraColorado80045
Kathy Prinz, CRC
[email protected]
303-724-9815
Sarah Bunting, CRC
[email protected]
303-724-9815
Sapna Patel, MD (PRINCIPAL_INVESTIGATOR)
Georgetown University Medical CenterWashington D.C.District of Columbia20007
Jamie Manganti, BSN, RN
[email protected]
202-687-3937
Bethelhem Mekonen, BSN, RN
[email protected]
202-444-0241
Suthee Rapisuwon, MD (PRINCIPAL_INVESTIGATOR)
UPMC Hillman Cancer CenterPittsburghPennsylvania15232
Amy Rose, RN, BSN
[email protected]
412-647-8587
Samantha Berton, RN, BSN
[email protected]
Diwakar Davar, MD, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Colorado Cancer Center· Aurora, COGeorgetown University Medical Center· Washington D.C., DCUPMC Hillman Cancer Center· Pittsburgh, PA

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