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Study of Tebentafusp and Pembrolizumab for Patients with Previously Treated Advanced Melanoma

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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 treatments for advanced melanoma, a type of skin cancer that has spread to other parts of the body. The study will explore the effectiveness of a medication called tebentafusp, both on its own and in combination with another medication called pembrolizumab (also known as Keytruda). Participants in the study will have previously received treatment for their melanoma. The purpose of the study is to see if these treatments can help reduce the cancer and improve survival rates compared to other treatments chosen by the doctors involved in the study.

During the study, participants will receive either the tebentafusp regimen or a treatment selected by their doctor, which may include medications like diphenhydramine, dexamethasone, or paracetamol. Tebentafusp and pembrolizumab are given through an intravenous infusion, which means they are administered directly into the bloodstream through a vein. The study will last for a period of up to 24 months, during which the participants' health and response to the treatment will be closely monitored.

The study aims to determine if the tebentafusp regimen can lead to a greater reduction in cancer markers and improve overall survival compared to the other treatments. Participants will be monitored for any side effects and changes in their health throughout the study. The results will help researchers understand the potential benefits of tebentafusp for people with advanced melanoma and guide future treatment options.

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, participants will be informed about the trial's objectives and procedures. Participants must provide informed consent, agreeing to comply with the study requirements.

  2. Step 2

    Initial assessment

    Participants will undergo an initial assessment to confirm eligibility. This includes providing a tumor tissue sample and undergoing tests to measure disease status and overall health.

  3. Step 3

    Treatment assignment

    Participants will be randomly assigned to receive either the tebentafusp regimen or the investigator's choice of treatment. The assignment is random to ensure unbiased results.

  4. Step 4

    Treatment administration

    Participants receiving tebentafusp will have it administered as an intravenous infusion. The frequency and dosage will be determined by the study protocol.

    Participants may also receive pembrolizumab as an intravenous infusion, depending on their treatment group.

    Other medications such as diphenhydramine, dexamethasone, and paracetamol may be administered orally or intravenously to manage side effects.

  5. Step 5

    Monitoring and follow-up

    Participants will have regular follow-up visits to monitor their health and the effects of the treatment. This includes blood tests, imaging studies, and assessments of side effects.

    The study team will evaluate the reduction of ctDNA, a marker in the blood, and overall survival rates.

  6. Step 6

    Completion of the study

    Upon completion of the treatment period, participants will have a final assessment to evaluate the outcomes of the study.

    Participants may be asked to provide feedback on their experience and any changes in their quality of life.

Who can join the trial?

9 criteria

  • You must be 18 years of age or older.
  • You must have a specific genetic marker called HLA-A*02:01-positive.
  • You must have unresectable Stage III or Stage IV non-ocular melanoma. This means the melanoma cannot be removed by surgery and is in an advanced stage.
  • You need to provide a tumor tissue sample, either newly obtained or from previous tests.
  • You must have either measurable or non-measurable disease according to specific medical guidelines (RECIST v1.1).
  • Your performance status must be 0 or 1 on the ECOG scale, which measures your ability to perform daily activities.
  • If you are of childbearing potential and sexually active with a non-sterilized partner, you must agree to use highly effective methods of contraception.
  • You must be able to give informed consent, meaning you understand and agree to the study's requirements and restrictions.
  • You must agree to provide all necessary samples for biomarker analysis, which are tests to study specific biological markers in your body.

Who cannot join the trial?

3 criteria

  • Patients who have already received treatment for advanced melanoma that is not in the eye.
  • Patients who are not within the specified age range for the study.
  • Patients who belong to a vulnerable population, which means they might need special protection or care.
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Investigated drugs

  • Tebentafusp

    is a medication being studied for its potential to treat advanced melanoma, a type of skin cancer. It works by helping the immune system recognize and attack cancer cells. This medication is specifically designed for patients who have a certain genetic marker called HLA-A*02:01. The goal of using Tebentafusp in this trial is to see if it can reduce the amount of cancer DNA in the blood and improve the overall survival of patients compared to other treatments chosen by the doctors.

  • Pembrolizumab

    is another medication being tested in combination with Tebentafusp. It is an immunotherapy drug that helps the body's immune system fight cancer. Pembrolizumab works by blocking a specific protein on cancer cells, which allows the immune system to better detect and destroy these cells. In this trial, researchers are exploring whether combining Pembrolizumab with Tebentafusp can enhance the treatment's effectiveness in patients with advanced melanoma.

What is already known about the treatment

Tebentafusp – Tebentafusp is administered as an injection and is currently being studied in clinical trials for its effectiveness in treating advanced melanoma, a type of skin cancer, in patients who have already received other treatments. It is being tested both alone and in combination with another medication called Pembrolizumab. The main goal of these trials is to see if Tebentafusp can help reduce cancer-related DNA in the blood and improve survival rates. At the molecular level, Tebentafusp works by targeting specific proteins on cancer cells, helping the immune system recognize and attack these cells. It is classified as an immunotherapy, which means it helps the body's immune system fight cancer.

Investigated diseases

Advanced Melanoma – Advanced melanoma is a type of skin cancer that has spread beyond the original site to other parts of the body. It begins in the melanocytes, which are the cells responsible for producing melanin, the pigment that gives skin its color. As the disease progresses, it can invade nearby tissues and organs, leading to more complex symptoms. The progression often involves the lymph nodes, lungs, liver, brain, and bones. Symptoms may include changes in existing moles, the appearance of new pigmented or unusual-looking growths on the skin, and systemic symptoms like fatigue or weight loss. The disease can be aggressive, with the potential for rapid spread and significant impact on the body's systems.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2022-502732-39-00Protocol codeIMCgp100-203Estimated enrolment540 patientsSponsorImmunocore Limited

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