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Study of Tebentafusp for Patients with Metastatic Uveal Melanoma and Resectable Liver Metastasis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of eye cancer called metastatic uveal melanoma, which has spread to the liver but not to other parts of the body. The treatment being tested is called tebentafusp, which is given as an infusion, meaning it is delivered directly into the bloodstream through a vein. The main goal of the study is to see if tebentafusp can help eliminate the cancer in the liver.

Participants in the study will receive tebentafusp and will be monitored over several months to see how their cancer responds to the treatment. The study will look at whether the cancer completely disappears, as well as other outcomes like how long patients live without the cancer coming back. The study will also check for any side effects from the treatment.

Throughout the study, researchers will collect samples from the liver and blood to better understand how tebentafusp works and to identify any markers that might predict how well the treatment will work. This information could help improve future treatments for metastatic uveal melanoma.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon joining the trial, the patient will receive a detailed explanation of the study, including its purpose and procedures. The patient will be required to provide written and signed informed consent, which confirms understanding and agreement to participate in the study.

  2. Step 2

    Initial assessment

    The patient will undergo an initial assessment to confirm eligibility. This includes verifying the presence of metastatic uveal melanoma with resectable liver metastasis and ensuring there is no disease outside the liver. The patient's health status will be evaluated, including organ function and performance status.

  3. Step 3

    Treatment with tebentafusp

    The patient will begin treatment with tebentafusp, administered as an intravenous infusion. The specific dosage and frequency will be determined by the medical team based on the patient's condition and response to treatment. The treatment aims to achieve a complete response, meaning no detectable cancer remains.

  4. Step 4

    Monitoring and follow-up

    Throughout the treatment, the patient will be closely monitored for any side effects or adverse reactions. Regular follow-up visits will be scheduled to assess the patient's response to the treatment and to perform necessary tests, such as blood samples and imaging studies.

  5. Step 5

    Evaluation of response

    After approximately 7 months, the patient's response to the treatment will be evaluated. This includes assessing whether there is any remaining cancer through biopsy or surgical resection. If the patient achieves a complete response, they may continue treatment with tebentafusp without proceeding to surgery.

  6. Step 6

    Completion of trial participation

    Upon completion of the trial, the patient will have a final assessment to determine the overall outcome of the treatment. The medical team will discuss the results and any further steps or follow-up care that may be necessary.

Who can join the trial?

15 criteria

  • Patients must have a confirmed diagnosis of metastatic uveal melanoma with liver metastasis that can be surgically removed, and no disease outside the liver.
  • Patients must test positive for Human leukocyte antigen-A*0201, which is a specific protein on the surface of cells, determined by a local test.
  • Patients must not have received any previous systemic treatment for advanced or metastatic disease, including chemotherapy, immunotherapy, or targeted therapy.
  • Patients must not have had any previous local treatments directed at the liver, such as chemotherapy, radiotherapy, radiofrequency ablation (RFA), or embolization.
  • Previous treatment given before surgery to shrink the tumor (neoadjuvant therapy) is allowed if it was given with the intent to cure localized disease.
  • Patients must provide a written and signed informed consent approved by an Institutional Review Board (IRB) or Independent Ethics Committee (IEC).
  • Patients must be male or female and at least 18 years old at the time of giving informed consent.
  • Patients must have an Eastern Cooperative Oncology Group Performance Status (ECOG-PS) of 0-1, which is a scale used to assess how a patient's disease is progressing and how the disease affects their daily living abilities.
  • Patients must have adequate organ function, which includes:
    • Hemoglobin levels of at least 9.0 g/dL.
    • An absolute neutrophil count (ANC) greater than 1.5 x 109/L.
    • A platelet count of at least 100 x 109/L.
    • Serum bilirubin levels no more than 1.5 times the institutional upper limit of normal, except for patients with Gilbert's syndrome, a condition with mild jaundice.
    • Both AST and ALT liver enzymes must be less than 5 times the upper limit of normal.
    • Creatinine clearance of at least 50 ml/min, which measures kidney function.
    • No significant abnormalities in potassium, magnesium, calcium, or phosphate levels.

Who cannot join the trial?

4 criteria

  • Patients with **extra-liver disease** cannot participate. This means if the cancer has spread outside the liver, you cannot join the study.
  • Patients with **unresectable liver metastasis** are excluded. This means if the liver tumors cannot be removed by surgery, you cannot join the study.
  • Patients who are not within the specified **age range** cannot participate. The study is open to certain age groups only.
  • Patients who are part of a **vulnerable population** are not eligible. This refers to groups who may need special protection or care.
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Investigated drugs

Tebentafusp is a medication being studied for its potential to treat a type of eye cancer called uveal melanoma, which has spread to the liver. This medication is designed to help the body's immune system recognize and attack cancer cells. In this clinical trial, researchers are looking to see if using tebentafusp alone can lead to a complete disappearance of cancer in the liver before surgery. The goal is to see if this treatment can help patients by reducing the cancer to a point where it can be completely removed.

What is already known about the treatment

Tebentafusp – Tebentafusp is administered as an injection, typically given under the skin. It is currently being studied in clinical trials for its effectiveness in treating metastatic uveal melanoma, specifically in patients with liver metastasis that can be surgically removed and no disease outside the liver. The main goal of using tebentafusp is to see if it can completely eliminate cancer cells in these patients. At the molecular level, tebentafusp works by helping the immune system recognize and attack cancer cells. It is classified as an immunotherapy, which means it uses the body's own immune system to fight cancer.

Investigated diseases

Metastatic Uveal Melanoma – This is a type of cancer that originates in the uveal tract of the eye, which includes the iris, ciliary body, and choroid. It is characterized by the spread of cancer cells from the eye to other parts of the body, most commonly the liver. In cases with resectable liver metastasis, the cancer has spread to the liver but can potentially be removed through surgery. The disease progresses as cancer cells grow and multiply, forming tumors in the liver. It typically does not involve other organs outside the liver in the absence of extra-liver disease. The progression can vary, but it often involves the growth of liver tumors and potential spread to other areas if not contained.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-509076-42-00Protocol codeGEM 2302Estimated enrolment19 patientsSponsorGrupo Espanol Multidisciplinar De Melanoma

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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