NCT06070012

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

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)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Diwakar Davar · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 including IMCgp100-01 (NCT01211262; ≥2L cutaneous and uveal melanoma), IMCgp100-102 (NCT02570308; ≥2L uveal melanoma), IMCgp100-201 (NCT02535078; PD-1 naïve and PD-1 R/R cutaneous melanoma), and IMCgp100-202 (NCT03070392; 1L uveal melanoma vs. physicians' choice chemotherapy). Based on early first-in-human (FIH) studies, tebentafusp 68 mcg was identified as the RP2D; with an intra- patient escalation regimen (20 mcg at C1D1 and 30 mcg at C1D8) and the dose escalated at C1D15. This dose was subsequently evaluated in a recently completed phase -II trial - IMC-p100-202 - that randomized 378 treatment-naïve, HLA-A\*0201 positive patients with advanced uveal melanoma on a 2-to-1 ratio to tebentafusp (n = 252) or investigator's choice (IC) of dacarbazine, ipilimumab, or pembrolizumab (n = 126). Based on the data from the IMCgp100-202 study, the current approved dose of tebentafusp is a fixed starting dose of 20mcg (C1D1), followed by 30 mcg (C1D8) and 68mcg at C1D15 and beyond.

Conditions

• Uveal Melanoma

Interventions

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

Timeline

• Start date: 2025-08-18
• Primary completion: 2028-09-30
• Completion: 2030-09-30
• First posted: 2023-10-06
• Last updated: 2026-02-27

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study