Neoadjuvant Tebentafusp in Patients With Metastatic Uveal Melanoma
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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%).
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Potwierdzony czerniak oczny z przerzutami do wątroby
- •Przerzuty w wątrobie można całkowicie lub częściowo usunąć operacyjnie
- •Brak przerzutów poza wątrobą
- •Wcześniej nie stosowano systemowego leczenia (chemioterapia, immunoterapia) na przerzuty
- •Wcześniej nie leczono wątroby chemioterapią, radioterapią ani innymi metodami
- •Wiek co najmniej 18 lat
- •Dobry ogólny stan zdrowia
- •Prawidłowe wyniki badań krwi i funkcji narządów
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- September 15, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (4)
Charité - Universitätsmedizin Berlin
Berlin, Germany
Institut Catala d'Oncologia (ICO) Hospitalet
L'Hospitalet de Llobregat, Spain
Hospital La Paz
Madrid, Spain
Consorcio Hospital General Universitario de Valencia
Valencia, Spain
Trial contact
Federico Nepote
Josep Maria Piulats, M.D., Ph.D.
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 9/16/2026.
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