OncoMatch/Clinical Trials/NCT06414590
Neoadjuvant Tebentafusp for Uveal Melanoma
Is NCT06414590 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Tebentafusp-Tebn for locally advanced unresectable uveal melanoma.
Treatment: Tebentafusp-Tebn — This phase II trial tests how well tebentafusp works to shrink tumors prior to primary treatment with surgery or radiation in patients with uveal (eye) melanoma that has spread to nearby tissue or lymph nodes (locally advanced) or that cannot be removed by surgery (unresectable). Tebentafusp is a drug that binds to melanoma tumor cells as well as immune cells called T-cells. This binding causes an immune response against the melanoma cells, which leads to tumor cell death. Tebentafusp has been approved for the treatment of locally advanced and unresectable uveal melanoma. Giving tebentafusp before primary treatment with surgery or radiation may help shrink the tumor, prevent the disease from spreading, or reduce the likelihood that patients will require total eye removal (called enucleation).
Check if I qualifyExtracted eligibility criteria
Cancer type
Melanoma
Biomarker criteria
Required: HLA-A A*02:01 positive
Participants must be HLA-A*02:01 positive
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: (Tebentafusp)
Previous treatment with Tebentafusp
Lab requirements
Blood counts
Absolute neutrophil count < 1.0 x 10^9 /L; Absolute lymphocyte count < 0.5 x 10^9 /L; Platelet count < 100 x 10^9 /L; Hemoglobin < 9.0 g/dL
Kidney function
Serum creatinine > 1.5 x ULN and/or creatinine clearance < 50 mL/minute
Liver function
Total bilirubin >1.5 mg/dL (or 1.3 x ULN); Alanine aminotransferase > 1.5 x ULN; Aspartate aminotransferase > 1.5 x ULN; Albumin < 3.0 g/dl
Cardiac function
Left Ventricular Ejection Fraction <50%; QTcF > 470 msec on screening ECG or congenital long QT syndrome; Acute myocardial infarction or unstable angina pectoris < 6 months to Screening; Clinically significant and/or uncontrolled heart disease such as congestive heart failure (NYHA grade ≥ 2), uncontrolled hypertension, or clinically significant arrhythmia uncontrolled with medical treatment
Patients with any out-of-range laboratory values defined as: Serum creatinine > 1.5 x ULN and/or creatinine clearance < 50 mL/minute; Albumin < 3.0 g/dl; Total bilirubin >1.5 mg/dL (or 1.3 x ULN); Alanine aminotransferase > 1.5 x ULN; Aspartate aminotransferase > 1.5 x ULN; Absolute neutrophil count < 1.0 x 10^9 /L; Absolute lymphocyte count < 0.5 x 10^9 /L; Platelet count < 100 x 10^9 /L; Hemoglobin < 9.0 g/dL; Uncorrectable abnormal potassium, magnesium, corrected calcium or phosphate abnormality of NCI CTCAE v5.0 > grade 1; Morning cortisol < lower limit of normal (unless the patient has asymptomatic adrenal insufficiency and is receiving stable replacement doses)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Sidney Kimmel Cancer Center at Thomas Jefferson University · Philadelphia, Pennsylvania
- Wills Eye Hospital · Philadelphia, Pennsylvania
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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