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Title: Comparing tebentafusp treatment versus observation in patients with high-risk eye melanoma (uveal melanoma) after initial treatment

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 study focuses on uveal melanoma, a type of eye cancer that develops in a part of the eye called the uvea. The research examines the effectiveness of a medication called tebentafusp (KIMMTRAK) given through intravenous infusion after patients have completed their initial treatment with surgery or radiation therapy.

The study aims to determine if using tebentafusp after initial treatment helps prevent the cancer from returning. Patients who participate will either receive tebentafusp treatment or be placed in an observation group. The treatment period may last up to 6 months, during which patients receiving the medication will get infusions of tebentafusp.

The medication being studied, tebentafusp, is designed specifically for patients whose cancer cells have a particular genetic marker called HLA-A*02:01. During the treatment, doctors will monitor patients for any changes in their condition and keep track of how long patients remain free from cancer recurrence. Regular check-ups and medical tests will be performed to ensure patient safety throughout the study period.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial medical assessment

    You have been diagnosed with uveal melanoma (eye melanoma) and have completed either surgery or radiation therapy within the last 11 weeks

    Your doctor will assess if you are at high risk based on either stage III cancer or specific genetic test results

    Your physical condition will be evaluated using the ECOG scale, which must be 0 or 1 (able to perform daily activities)

  2. Step 2

    Screening tests

    A test will be performed to confirm if you are HLA-A*02:01 positive

    Imaging tests will be conducted to confirm there is no cancer recurrence

    Blood tests will check your organ function, including liver, kidney, and blood cell counts

    For women of childbearing age, a pregnancy test will be performed

  3. Step 3

    Treatment assignment

    You will be randomly assigned to one of two groups:

    Group 1: Receiving tebentafusp treatment

    Group 2: Observation only (no treatment)

  4. Step 4

    Treatment period

    If assigned to the treatment group, you will receive KIMMTRAK (tebentafusp) through infusion

    The medication contains 100 micrograms per 0.5 mL

    Treatment will continue until medical assessment determines it should stop

  5. Step 5

    Follow-up period

    Regular check-ups will monitor for any cancer recurrence

    Your overall health status will be tracked

    The study will continue until 2032

Who can join the trial?

11 criteria

  • Must be 18 years or older
  • Must have primary uveal melanoma (cancer in the eye) that has not spread, excluding iris melanoma, and have completed either surgery or radiation therapy
  • Must be considered high-risk based on either: - Stage III cancer, or - Specific genetic features of the tumor
  • Must have completed primary treatment within 11 weeks before joining the study
  • Must be HLA-A*02:01 positive (a specific genetic marker)
  • Must have good physical function (ECOG performance status of 0 or 1, meaning able to perform daily activities)
  • Must have adequate organ function, including: - Normal kidney function - Normal liver function - Normal blood cell counts
  • For women who can become pregnant: - Must have a negative pregnancy test - Must use effective birth control during treatment and for 6 months after
  • For breastfeeding women: - Must agree to stop breastfeeding during treatment and for 6 months after
  • Must show no signs of cancer returning on medical imaging within 4 weeks before starting the study
  • Must provide written informed consent to participate in the study

Who cannot join the trial?

13 criteria

  • Prior systemic treatment for uveal melanoma (cancer of the eye)
  • History of other cancers within the past 3 years, except for adequately treated non-melanoma skin cancer or cervical cancer
  • Presence of active or untreated brain metastases (cancer spread to the brain)
  • Severe heart conditions including heart failure, unstable angina, or recent heart attack
  • Uncontrolled high blood pressure
  • Severe liver or kidney disease
  • Active or chronic infections including hepatitis B, hepatitis C, or HIV
  • Autoimmune conditions requiring systemic treatment
  • Pregnancy or breastfeeding
  • Known allergy or sensitivity to the study medication or its components
  • Participation in another clinical trial within 30 days before starting this study
  • Mental conditions that could interfere with study compliance
  • Any condition that, in the investigator's opinion, makes the patient unsuitable for the trial
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Investigated drugs

Tebentafusp (also known as IMCgp100) is a bispecific protein drug that helps the immune system recognize and fight cancer cells. It is specifically designed for patients who have a certain genetic marker called HLA-A*02:01 and are diagnosed with uveal melanoma (a type of eye cancer). This medication works by connecting immune cells to cancer cells, enabling the immune system to better target and destroy the cancer. It is given to patients after their initial cancer treatment to help prevent the cancer from coming back. Observation is the standard approach where patients are regularly monitored by their healthcare team without receiving active treatment. During observation, doctors perform regular check-ups and tests to watch for any signs that the cancer might be returning.

What is already known about the treatment

Tebentafusp - A novel bispecific fusion protein medication administered through intravenous infusion, specifically designed for patients with HLA-A*02:01-positive uveal melanoma. This immunotherapy agent works by simultaneously binding to both T-cells and melanoma cells, redirecting the immune system to target and destroy cancer cells. Tebentafusp belongs to the class of biologic immunotherapeutic agents and represents a significant advancement in treating uveal melanoma, particularly in the adjuvant setting following primary treatment. The medication functions by creating a bridge between the patient's T-cells and melanoma cells, enabling the immune system to recognize and attack the cancer cells more effectively.

Investigated diseases

Uveal Melanoma - A rare type of cancer that develops in the uvea, the middle layer of the eye that contains blood vessels and pigment cells. The disease begins when pigment-producing cells called melanocytes in the uvea start growing abnormally and form a tumor. These tumors typically develop in one eye and can affect any part of the uveal tract, including the iris, ciliary body, or choroid. As the tumor grows, it can cause changes in vision or visible changes to the eye's appearance. The disease can spread from its original location to other parts of the body through the bloodstream.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-510333-28-00Protocol codeEORTC 2022-MGEstimated enrolment310 patientsSponsorEuropean Organisation For Research And Treatment Of Cancer

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