OncoMatch/Clinical Trials/NCT06414590
Neoadjuvant Tebentafusp for Uveal Melanoma
Is NCT06414590 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies Tebentafusp-Tebn for locally advanced unresectable uveal melanoma.
Treatment: Tebentafusp-Tebn — This is a prospective, single arm, phase II clinical trial of neoadjuvant Tebentafusp (KIMMTRAK®) in patients with locally advanced primary uveal melanoma. Patients must be HLA-A\*02:01 with large, surgically unresectable (other than complete enucleation of the eye) primary uveal melanoma. The efficacy of this treatment will be assessed with the Simon's two stage design. The choice of design is guided by a desire to stop the trial early if the actual regression rate of primary uveal melanoma is 1% or lower.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
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 (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); ALT > 1.5 x ULN; AST > 1.5 x ULN; Albumin < 3.0 g/dl
Cardiac function
Left Ventricular Ejection Fraction <50%; 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; Acute myocardial infarction or unstable angina pectoris < 6 months to Screening
See exclusion criterion 4 (renal, hepatic, hematologic labs), criterion 6 (cardiac function)
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 →Frequently asked questions
Is NCT06414590 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require HLA-A?
Yes, HLA-A a*02:01 is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages