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

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06070012
Study type	Interventional
Source	University of Pittsburgh
Contact	Amy Rose, RN, BSN
Phone	412-647-8587
Email	kennaj@upmc.edu
Status	Not yet recruiting
Phase	Phase 2
Start date	June 30, 2024
Completion date	June 30, 2029

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT04364230` - Melanoma Vaccine Against Neoantigen and Shared Antigens by CD40 Activation and TLR Agonists In Patients With Melanoma (Including Ocular Melanoma)	Phase 1/Phase 2
Completed	`NCT03652077` - A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies	Phase 1
Active, not recruiting	`NCT05542342` - Sitravatinib and Tislelizumab in Patients With Metastatic Uveal Melanoma With Liver Metastases.	Phase 2
Completed	`NCT02849145` - Evaluation Interest of the Circulating Tumor DNA Dosage in Patient With Hepatic Metastatic Uveal Melanoma Candidate to Complete Resection (ct DNA R0)	N/A
Recruiting	`NCT01438658` - Assessing the Clinical Effectiveness of Serum Biomarkers in the Diagnosis of Metastatic Uveal Melanoma	N/A
Not yet recruiting	`NCT00811200` - Treatment Of Radiation Retinopathy Trial	Phase 2/Phase 3
Completed	`NCT00121225` - Vorinostat in Treating Patients With Metastatic or Unresectable Melanoma	Phase 2
Recruiting	`NCT05077280` - A Study of Concurrent Stereotactic Body Radiotherapy With Opdualag in Metastatic Uveal Melanoma	Phase 2
Completed	`NCT03297424` - A Study of PLX2853 in Advanced Malignancies.	Phase 1
Withdrawn	`NCT05482074` - Olaparib in Unresectable/Metastatic Melanoma With BRCA1/2	Phase 2
Completed	`NCT04551352` - A Study of RO7293583 in Participants With Unresectable Metastatic Tyrosinase Related Protein 1 (TYRP1)-Positive Melanomas	Phase 1
Not yet recruiting	`NCT06246149` - Adjuvant Tebentafusp in High Risk Ocular Melanoma	Phase 3
Completed	`NCT01955941` - Vascular Response to Brachytherapy Using Functional OCT
Completed	`NCT00661622` - Halt Growth of Liver Tumors From Uveal Melanoma With Closure of Liver Artery Following Injection of GM-CSF	Phase 2
Recruiting	`NCT05502900` - Adjuvant Melatonin for Uveal Melanoma	Phase 3
Active, not recruiting	`NCT03070392` - Safety and Efficacy of IMCgp100 Versus Investigator Choice in Advanced Uveal Melanoma	Phase 2
Recruiting	`NCT06284512` - Uveal Melanoma - Comparative Study
Recruiting	`NCT05524935` - Olaparib in Combination With Pembrolizumab for Advanced Uveal Melanoma	Phase 2
Active, not recruiting	`NCT02913417` - Yttrium90, Ipilimumab, & Nivolumab for Uveal Melanoma With Liver Metastases	Phase 1/Phase 2
Not yet recruiting	`NCT06073548` - Patient Experience and Quality of Life During the Surveillance Phase of Uveal Melanoma: A Prospective Multi-method Study

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms