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Study on Tebentafusp and Drug Combination for Patients with Advanced Uveal Melanoma

Verified siteRegistered drugNo placebo
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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 advanced uveal melanoma, which has not been treated before. The study is comparing the effects of a new treatment called tebentafusp (also known by its code name IMCgp100) with other treatments chosen by doctors. The main goal is to see how well patients do with tebentafusp compared to other treatments, especially looking at how long patients live and how they respond to the treatment.

Participants in the study will receive their assigned treatment through an intravenous infusion, which means the medicine is given directly into a vein. The study will last for up to 24 months, during which time patients will be monitored for their overall health and any side effects they might experience. The study will also look at how the body processes the medicine and any changes in the patient's condition over time.

In addition to tebentafusp, the study involves other medications such as dacarbazine, pembrolizumab (known as Keytruda), and ipilimumab (known as Yervoy). These medications are also given through intravenous infusion and are part of the treatment options that doctors may choose for patients in the study. The study aims to provide valuable information on the safety and effectiveness of these treatments for patients with advanced 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 study

    Upon joining the study, eligibility is confirmed. This includes being 18 years or older, having a confirmed diagnosis of advanced uveal melanoma, and meeting specific health criteria.

    No prior systemic therapy for advanced melanoma is allowed. Previous surgical resection or localized treatment is acceptable.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of two groups: tebentafusp monotherapy or investigator's choice monotherapy.

    The objective is to compare overall survival between these groups.

  3. Step 3

    Treatment administration

    For those receiving tebentafusp, the medication is administered via intravenous infusion.

    Participants in the investigator's choice group may receive one of the following medications: dacarbazine, pembrolizumab (Keytruda), or ipilimumab (Yervoy), all administered through intravenous infusion.

  4. Step 4

    Monitoring and assessments

    Regular monitoring of health status, including laboratory tests, vital signs, and electrocardiograms, is conducted to ensure safety and tolerability.

    Participants are assessed for any side effects or adverse events related to the treatment.

  5. Step 5

    Evaluation of treatment response

    The effectiveness of the treatment is evaluated through various measures, including overall survival and progression-free survival.

    Quality of life assessments are conducted using standardized questionnaires.

  6. Step 6

    Study completion

    The study is expected to conclude by July 31, 2025.

    Final evaluations are conducted to assess the long-term outcomes of the treatments.

Who can join the trial?

12 criteria

  • Patients must be **18 years of age or older**.
  • Patients must be able to **provide and understand written informed consent**. This means they agree to participate and understand what the study involves.
  • Patients must have **metastatic uveal melanoma (UM)** confirmed by tests. This means the cancer has spread from the eye to other parts of the body.
  • Patients must not have had any **prior systemic therapy** for their advanced cancer. This includes treatments like chemotherapy, immunotherapy, or targeted therapy.
  • Patients must not have had any **prior regional, liver-directed therapy**. This includes treatments like chemotherapy, radiotherapy, or embolization directed at the liver.
  • Patients may have had **prior surgical removal of limited metastatic disease**. This means surgery to remove small areas where the cancer has spread is allowed.
  • Patients may have had **prior neoadjuvant or adjuvant therapy** if it was given to cure localized disease. These are treatments given before or after the main treatment to help cure the cancer.
  • Patients must be **HLA-A*0201 positive**. This is a specific genetic marker that must be present.
  • Patients must have a **life expectancy of more than 3 months**.
  • Patients must have an **ECOG Performance Status of 0 or 1**. This is a scale that measures how well patients can perform daily activities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to carry out light work.
  • Patients must have **measurable or non-measurable disease** according to **RECIST v1.1**. This is a set of guidelines used to measure how well a cancer treatment is working.
  • All other relevant medical conditions must be **well-managed and stable**. This means any other health issues should be under control.

Who cannot join the trial?

5 criteria

  • Patients who have already received treatment for their advanced uveal melanoma cannot participate.
  • Patients who do not have the specific genetic marker called HLA-A*0201 are excluded. This marker is a type of protein found on the surface of cells that helps the immune system recognize foreign substances.
  • Patients who are not able to develop a rash within the first week of treatment with tebentafusp are excluded. A rash is a noticeable change in the texture or color of the skin.
  • Patients who are not within the specified age range for the study cannot participate. The study includes adults and older adults.
  • Patients who are part of a vulnerable population, which means they might have additional health or social challenges, are excluded.
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Investigated drugs

  • IMCgp100

    is a medication being studied for its safety and effectiveness in treating advanced uveal melanoma, a type of eye cancer. It is being compared to other treatments chosen by the investigator. This medication is specifically for patients who have not received any prior treatment for their metastatic cancer and have a specific genetic marker called HLA-A*0201.

  • Tebentafusp

    is another name for the medication IMCgp100. It is being tested to see if it can improve overall survival in patients with advanced uveal melanoma. The study is also looking at how patients who develop a rash within the first week of treatment respond to this medication compared to other treatments chosen by the investigator.

What is already known about the treatment

Tebentafusp – Tebentafusp is administered as an intravenous infusion and is currently being studied in clinical trials for its effectiveness in treating advanced uveal melanoma, particularly in patients who have not received prior treatment. It is a promising therapy in the field of oncology, with ongoing research to establish its safety and efficacy. The medication works by targeting specific proteins on cancer cells, helping the immune system recognize and attack these cells. Tebentafusp is classified as an immunotherapy, which is a type of treatment that uses the body's immune system to fight cancer.

Investigated diseases

Uveal Melanoma – Uveal melanoma is a rare type of cancer that occurs in the eye, specifically in the uvea, which includes the iris, ciliary body, and choroid. It is the most common primary intraocular malignancy in adults. The disease often progresses silently, with symptoms such as visual disturbances or changes in the appearance of the eye appearing only in advanced stages. As the melanoma grows, it can lead to complications such as retinal detachment or glaucoma. If the cancer spreads beyond the eye, it typically affects the liver, lungs, or bones. Early detection is challenging due to the lack of symptoms in the initial stages.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-517290-24-00Protocol codeIMCgp100-202Estimated enrolment193 patientsSponsorImmunocore Limited

sourced from the EU Clinical Trials Register and site verification

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