OncoMatch/Clinical Trials/NCT06070012
Tebentafusp in HLA-A*0201 Positive Previously Untreated Metastatic Uveal Melanoma
Is NCT06070012 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Tebentafusp for uveal melanoma.
Treatment: Tebentafusp — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Melanoma
Biomarker criteria
Required: HLA-A A*0201 positive
HLA-A*0201 genotype positive as assessed using a CLIA-certified blood typing method and confirmed by central review.
Disease stage
Metastatic disease required
untreated metastatic uveal melanoma (mUM). Patients have measurable disease according to RECIST v.1.1.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic therapy
Exception: Prior neoadjuvant or adjuvant therapy is allowed provided administered in the curative setting in patients with localized disease.
No prior systemic therapy in the metastatic or advanced setting including chemotherapy, or targeted therapy.
Cannot have received: tebentafusp (tebentafusp)
Patients must be tebentafusp naïve.
Cannot have received: immune checkpoint inhibitor
Exception: Allowed if received >6 months prior to initial diagnosis of mUM.
Patients must not have received prior PD-1, CTLA-4, LAG-3 directed Immune Checkpoint Inhibitor therapy delivered in the adjuvant, and/or neoadjuvant settings unless such therapy was received >6 months prior initial diagnosis of mUM.
Cannot have received: regional, liver-directed therapy
No prior regional, liver-directed therapy including chemotherapy, radiotherapy, or embolization.
Lab requirements
Blood counts
Adequate organ function on screening labs obtained within 4 weeks of Week 1 day 1
Kidney function
Adequate organ function on screening labs obtained within 4 weeks of Week 1 day 1
Liver function
Adequate organ function on screening labs obtained within 4 weeks of Week 1 day 1
Cardiac function
Clinically significant cardiac disease or impaired cardiac function, including congestive heart failure (NYHA grade ≥ 2), uncontrolled hypertension, clinically significant arrhythmia, QTcF > 470 msec, congenital long QT syndrome, acute myocardial infarction or unstable angina pectoris < 6 months prior to Screening.
Adequate organ function on screening labs obtained within 4 weeks of Week 1 day 1. Clinically significant cardiac disease or impaired cardiac function, including any of the following: 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. Acute myocardial infarction or unstable angina pectoris < 6 months prior to Screening.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Colorado Cancer Center · Aurora, Colorado
- Georgetown University Medical Center · Washington D.C., District of Columbia
- UPMC Hillman Cancer Center · Pittsburgh, Pennsylvania
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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