OncoMatch/Clinical Trials/NCT07057596
Neoadjuvant Tebentafusp in Patients With Metastatic Uveal Melanoma
Is NCT07057596 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Tebentafusp for mestastatic uveal melanoma.
Treatment: Tebentafusp — Uveal melanoma (UM) is a rare type of melanoma, with an incidence of 4.4 cases per million in Europe each year. During recent years, different treatment approaches have been tested in patients with metastatic UM. Responses have been reported primarily with localized treatment in patients with a limited number of liver metastases. In cases of diffuse liver involvement or extrahepatic disease, systemic therapies are justified. However, to date, systemic therapies such as targeted therapy with selumetinib or conventional chemotherapy have failed in metastatic UM. Neo-TB is a Phase II, single arm, multicentre clinical trial designed to evaluate efficacy and safety of tebentafusp used as a single agent in patients with metastatic uveal melanoma with resectable / potentially resectable liver metastasis and absence of extrahepatic disease. The main questions it aims to answer are: 1. Which is the capacity of tebentafusp used as a single agent to generate pathological complete response (pCR) in patients with metastatic uveal melanoma with resectable liver metastasis and absence of extrahepatic disease. 2. Which is the efficacy of tebentafusp used as a single agent to maintain disease control and delay relapse / progression. 3. Which is the safety of tebentafusp used as a single agent in metastatic uveal melanoma. The main hypothesis is that neoadjuvant treatment with Tebentafusp could achieve ≥20% pathological complete response (pCR) in patients with metastatic uveal melanoma with resectable/potentially resectable liver metastasis and absence of extrahepatic disease. It is assumed that untreated patients would not present a pCR (response rate of ≤1%).
Check if I qualifyExtracted eligibility criteria
Cancer type
Melanoma
Biomarker criteria
Required: HLA-A A*0201 positive
Human leukocyte antigen-A*0201 positive determined by local assay
Disease stage
Metastatic disease required
histologically confirmed metastatic uveal melanoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic therapy
Exception: prior neoadjuvant or adjuvant therapy allowed if in curative setting for localized disease
No prior systemic therapy in the metastatic or advanced setting including chemotherapy, immunotherapy, or targeted therapy
Cannot have received: local, liver-directed therapy
No prior local, liver-directed therapy including chemotherapy, radiotherapy, radiofrequency ablation (RFA), or embolization
Cannot have received: Tebentafusp (Tebentafusp)
Previous treatment with Tebentafusp
Lab requirements
Blood counts
Hemoglobin ≥9.0 g/dL; ANC >1.5 x 10^9/L (>1500 per mm3); Platelet count ≥ 100 x 10^9/L (>75,000 per mm3)
Kidney function
Creatinine clearance ≥50 ml/min calculated by Cockcroft-Gault or another validated method
Liver function
Serum bilirubin ≤1.5 x institutional ULN (except Gilbert's syndrome, allowed with consultation); AST and ALT < 5 x ULN
Cardiac function
QTcF ≤ 470 msec on screening ECG; no clinically significant and/or uncontrolled heart disease (NYHA grade ≥ 2), uncontrolled hypertension, or clinically significant arrhythmia currently requiring medical treatment; no acute myocardial infarction or unstable angina pectoris < 6 months prior to Screening
Adequate organ function as defined below (without transfusion): Hemoglobin ≥9.0 g/dL. ANC >1.5 x 10^9/L (> 1500 per mm3). Platelet count ≥ 100 x 10^9/L (>75,000 per mm3). Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN)... Both AST and ALT must be < 5 x ULN. Creatinine clearance ≥50 ml/min... Potassium, magnesium, corrected calcium or phosphate abnormality of NCI CTCAE > grade 1. QTcF > 470 msec on screening ECG or congenital long QT syndrome.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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