Actively Recruiting
Neoadjuvant Tebentafusp in Patients With Metastatic Uveal Melanoma
Led by Grupo Español Multidisciplinar de Melanoma · Updated on 2026-03-06
19
Participants Needed
4
Research Sites
123 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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%).
CONDITIONS
Official Title
Neoadjuvant Tebentafusp in Patients With Metastatic Uveal Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed metastatic uveal melanoma positive for HLA-A*0201
- Metastatic liver lesions that are resectable or potentially resectable as determined by imaging and multidisciplinary team
- No prior systemic therapy or liver-directed local therapy for metastatic or advanced disease
- Previous neoadjuvant or adjuvant therapy allowed if given for localized disease
- Male or female patients aged 18 years or older
- Eastern Cooperative Oncology Group Performance Status (ECOG-PS) 0-1
- Adequate organ function including hemoglobin ≥9.0 g/dL, neutrophil count >1.5 x 10^9/L, platelet count ≥100 x 10^9/L, bilirubin ≤1.5 times upper limit of normal (ULN) except Gilbert's syndrome cases, AST and ALT <5 times ULN, creatinine clearance ≥50 ml/min
- Electrolyte abnormalities no worse than grade 1 according to NCI CTCAE
You will not qualify if you...
- Presence of extrahepatic disease
- Other active malignancies except non-melanoma skin cancer or superficial bladder cancer controlled locally; prior malignancy disease-free for 5 years
- History of severe allergic reactions to biologic drugs or monoclonal antibodies
- Significant or uncontrolled heart disease, including congestive heart failure NYHA grade ≥2, uncontrolled hypertension, significant arrhythmia requiring treatment, long QT syndrome, recent heart attack or unstable angina within 6 months
- History of adrenal insufficiency
- History of interstitial lung disease or pneumonitis requiring corticosteroids
- History of colitis or inflammatory bowel disease
- Active infection requiring systemic antibiotics or ongoing infection
- Known HIV infection
- Active hepatitis B or C infection
- Previous treatment with tebentafusp
- Use of systemic steroids or immunosuppressive drugs
- Major surgery within 2 weeks prior to study drug start
- Use of hematopoietic growth factors within 2 weeks prior to treatment
- Allergy to tebentafusp or its excipients
- Conditions preventing study completion or adequate follow-up
- Pregnant, breastfeeding, or women likely to become pregnant without effective contraception
- Male patients not surgically sterile or not using double barrier contraception during and for 1 week after treatment
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Charité - Universitätsmedizin Berlin
Berlin, State of Berlin, Germany, 10117
Actively Recruiting
2
Institut Catala d'Oncologia (ICO) Hospitalet
L'Hospitalet de Llobregat, Barcelona, Spain, 08908
Not Yet Recruiting
3
Hospital La Paz
Madrid, Madrid, Spain, 28046
Actively Recruiting
4
Consorcio Hospital General Universitario de Valencia
Valencia, Valencia, Spain, 46014
Actively Recruiting
Research Team
F
Federico Nepote
CONTACT
J
Josep Maria Piulats, M.D., Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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