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Study on the Effects of Sitravatinib and Tislelizumab for Patients with Metastatic Uveal Melanoma and Liver Metastases

Verified siteInvestigationalNo 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 cancer called metastatic uveal melanoma, which is a rare eye cancer that has spread to other parts of the body, particularly the liver. The study is testing a combination of two treatments: Sitravatinib and Tislelizumab. Sitravatinib, also known by its code name MGCD516, is a medication taken as a capsule that works by blocking certain proteins involved in cancer cell growth. Tislelizumab, known by its code name BGB-A317, is an immunotherapy given through an infusion, which helps the immune system recognize and attack cancer cells.

The purpose of this study is to evaluate how effective the combination of Sitravatinib and Tislelizumab is in treating patients with metastatic uveal melanoma that has spread to the liver. Participants in the study will receive these treatments and will be monitored over a period of time to see how their cancer responds. The study will look at how well the cancer shrinks or stops growing, as well as how long patients live without the cancer getting worse.

Throughout the study, participants will have regular visits to the clinic for treatment and check-ups. These visits will include various tests and examinations to monitor the effects of the treatment. The study aims to provide valuable information on the potential benefits of combining Sitravatinib and Tislelizumab for patients with this specific type of cancer.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    Upon joining the study, you will begin the initial treatment phase. This involves taking two medications: Sitravatinib and Tislelizumab.

    Sitravatinib is administered orally in the form of a hard capsule. The specific dosage and frequency will be provided by the study team.

    Tislelizumab is given as an intravenous infusion, which means it is delivered directly into your bloodstream through a vein. The study team will inform you about the schedule for these infusions.

  2. Step 2

    Ongoing treatment and monitoring

    Throughout the study, you will continue to receive Sitravatinib and Tislelizumab as per the schedule provided.

    Regular visits to the study site will be necessary for monitoring your health and the effectiveness of the treatment. This includes physical examinations, blood tests, and imaging studies such as CT or MRI scans.

    You will be required to donate liver metastasis biopsies on day 0 and day 42 since the start of the treatment.

  3. Step 3

    Follow-up phase

    After completing the treatment phase, you will enter a follow-up phase. This involves periodic visits to assess your health status and any long-term effects of the treatment.

    The study team will provide a schedule for these follow-up visits, which may include additional tests and assessments.

Who can join the trial?

17 criteria

  • Patients must have a confirmed diagnosis of metastatic uveal melanoma, which means the cancer has spread from the eye to other parts of the body, and it must be measurable.
  • Patients must be 18 years of age or older.
  • Patients must have a life expectancy of at least 4 months.
  • Patients must be able to swallow pills and not have any serious stomach or intestinal issues that would prevent the absorption of the medication.
  • Patients must have controlled blood pressure, with a systolic (upper number) of 140 mmHg or lower and a diastolic (lower number) of 90 mmHg or lower, with or without medication.
  • Patients must have at least one liver tumor that can be biopsied, which means a small sample can be taken for testing.
  • Patients who are HLA-A02:01 positive can have received one prior treatment with Tebentafusp for metastatic disease.
  • Patients must have an ECOG Performance Status of 0-1, which means they are fully active or have some symptoms but do not require bed rest during the day.
  • Patients must be able to give written informed consent, agreeing to the study's requirements and restrictions.
  • Patients must have normal organ and bone marrow function, including:
    • Hemoglobin levels of at least 9.0 g/dL.
    • White blood cell count (neutrophils) above 1.5 x 109/L.
    • Platelet count of at least 100 x 109/L.
    • Normal liver function tests, unless they have a condition called Gilbert’s syndrome.
    • Kidney function with creatinine clearance of at least 40 ml/min.
    • Low levels of protein in urine.
    • Females of childbearing potential must use a highly effective method of birth control during the study and for a specified time after the last dose of the study drugs. They must also have a negative pregnancy test before starting the study.
    • Males must use a highly effective method of birth control during the study and for a specified time after the last dose of the study drugs.

Who cannot join the trial?

6 criteria

  • Patients who do not have uveal melanoma. Uveal melanoma is a type of cancer that occurs in the eye.
  • Patients who do not have liver metastases. Liver metastases mean that the cancer has spread to the liver.
  • Patients who do not have a biopsiable disease. A biopsiable disease means that a sample of the tumor can be taken for testing.
  • Patients who have not received first-line systemic therapy with Tebentafusp. First-line systemic therapy is the initial treatment given for a disease.
  • Patients who are not HLA-A02:01 positive. HLA-A02:01 is a specific genetic marker that some people have.
  • Patients who have not received liver-directed therapy. Liver-directed therapy is a treatment specifically targeting the liver.
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Investigated drugs

  • Sitravatinib

    is a medication being studied for its potential to help treat a type of eye cancer that has spread to the liver, known as metastatic uveal melanoma. It works by blocking certain proteins that help cancer cells grow and spread. By doing this, Sitravatinib may help slow down or stop the growth of the cancer.

  • Tislelizumab

    is another medication being tested in this study. It is designed to help the body's immune system recognize and attack cancer cells. Tislelizumab works by blocking a protein that usually helps cancer cells hide from the immune system. By blocking this protein, Tislelizumab may help the immune system find and destroy the cancer cells more effectively.

What is already known about the treatment

  • Sitravatinib

    Sitravatinib is administered orally in the form of tablets. It is currently being studied in clinical trials for its potential use in treating metastatic uveal melanoma, particularly in patients with liver metastases. The medication works by inhibiting certain proteins that promote tumor growth and spread, thereby potentially slowing down or stopping the progression of cancer. Sitravatinib is classified as a tyrosine kinase inhibitor, a type of drug that blocks specific enzymes involved in cancer cell signaling.

  • Tislelizumab

    Tislelizumab is given through an intravenous infusion, meaning it is delivered directly into the bloodstream via a vein. It is being investigated in clinical trials for its effectiveness in treating metastatic uveal melanoma with liver metastases. This medication functions by blocking a protein that prevents the immune system from attacking cancer cells, thereby enhancing the body's natural ability to fight cancer. Tislelizumab is part of a class of drugs known as immune checkpoint inhibitors, which help to boost the immune response against cancer cells.

Investigated diseases

Uveal melanoma – Uveal melanoma is a type of cancer that occurs in the eye, specifically in the uvea, which includes the iris, ciliary body, and choroid. It begins when the pigment-producing cells in the uvea start to grow uncontrollably. As the disease progresses, it can lead to changes in vision or cause visible dark spots on the eye. The tumor may grow and invade nearby structures, potentially leading to complications within the eye. In some cases, the cancer cells can spread to other parts of the body, such as the liver. The progression of the disease can vary, with some tumors growing slowly while others may advance more rapidly.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-519451-29-00Protocol codeGEM-2101Estimated enrolment16 patientsSponsorGrupo Espanol Multidisciplinar De Melanoma

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