🏛️ Verified NIH Record • Updated 2026-02-25
Tebentafusp in HLA-A*0201 Positive Previously Untreated Metastatic Uveal Melanoma (NCT06070012)
🟢 Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Diwakar Davar
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (20 items) and avoid the listed exclusions (34 items).
Location: University of Colorado Cancer Center — Aurora, Colorado
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- History of severe hypersensitivity reactions (eg, anaphylaxis) to other biologic drugs or monoclonal antibodies.
- Clinically significant cardiac disease or impaired cardiac function, including any of the following:
- Clinically significant and/or uncontrolled heart disease such as congestive heart failure (New York Heart Association grade ≥ 2), uncontrolled hypertension, or clinically significant arrhythmia currently requiring medical treatment.
- QTcF \> 470 msec on screening electrocardiogram (ECG) or congenital long QT syndrome.
- NOTE: If the initial automated QTcF interval is \> 470 msec at screening, for the purpose of determining eligibility, the mean QTcF, based on at least 3 ECGs obtained over a brief time interval (ie, within 30 minutes), should be manually determined by a medically qualified person.
- NOTE: Acute myocardial infarction or unstable angina pectoris \< 6 months prior to Screening.
- Presence of symptomatic or untreated central nervous system (CNS) metastases, or CNS metastases that require doses of corticosteroids within the prior 3 weeks to study Day 1.
- Presence of active brain metastases.
- NOTE: Patients with brain metastases are eligible if all lesions have been treated surgically and/or radiosurgically and there is no evidence of progression for at least 2 weeks by MRI prior to the first dose of study drug.
- NOTE: Patients with any evidence of leptomeningeal disease are excluded.
- Active infection requiring systemic antibiotic therapy.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (3 Sites)
- University of Colorado Cancer Center — Aurora, Colorado
- Georgetown University Medical Center — Washington D.C., District of Columbia
- UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.