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Ongoing Clinical Trials for Uveal Melanoma

Uveal melanoma is a rare form of eye cancer that can spread to other parts of the body, most commonly the liver. Currently, 14 clinical trials are testing new treatments for this condition across multiple countries in Europe. These trials investigate various approaches, including targeted therapies, immunotherapies, and combination treatments, offering hope for patients at different stages of the disease. Trials are available for both localized eye tumors and cancer that has spread to other organs.

Clinical trial locations

Study of Darovasertib and Crizotinib for Patients with Metastatic Uveal Melanoma Who Are HLA-A2 Negative

This trial investigates a new treatment combination for patients with metastatic uveal melanoma who test negative for the HLA-A2 genetic marker. The study compares the combination of darovasertib and crizotinib against other doctor-selected treatments.

Inclusion criteria: Patients must be at least 18 years old with confirmed metastatic uveal melanoma and must test HLA-A2 negative. They should not have received previous systemic treatments for advanced cancer and must have at least one measurable tumor. Adequate organ function and an ECOG performance status of 0 or 1 are required. Women of childbearing age and sexually active men must use effective contraception.

Exclusion criteria: Patients who do not have HLA-A2 negative metastatic uveal melanoma, those outside the specified age range, or those considered part of a vulnerable population cannot participate.

Study focus: The trial aims to determine the optimal dose of the darovasertib and crizotinib combination and compare its effectiveness to standard treatments. The study measures progression-free survival and overall survival rates. Participants receive oral medications and undergo regular monitoring to assess treatment response and side effects.

Investigational drugs: Darovasertib is a protein kinase inhibitor designed to stop cancer cell growth. Crizotinib is a tyrosine kinase inhibitor that blocks specific proteins in cancer cells. Both medications are taken orally in tablet form.

Study of Darovasertib for Patients with Localized Uveal Melanoma

This study examines darovasertib as a treatment for localized uveal melanoma, testing whether it can shrink tumors before surgery or prevent cancer from returning after treatment.

Inclusion criteria: Patients must be at least 18 years old with a diagnosis of localized uveal melanoma that has not spread beyond the eye. They must be planning either eye removal surgery or radiation therapy. Tumor size requirements vary depending on the planned treatment. Patients must be able to swallow oral medication and have an ECOG performance status of 0 or 1. Women of childbearing potential must use effective birth control.

Exclusion criteria: Patients with other types of cancer, those who had a different cancer in the past 5 years, patients with serious heart problems, uncontrolled high blood pressure, active infections, or those who are pregnant or breastfeeding cannot participate. Patients unable to follow study procedures or with severe liver or kidney disease are also excluded.

Study focus: The trial evaluates how safe and tolerable darovasertib is when used before and after surgery or radiation treatment. It assesses whether the drug can shrink tumors before treatment and prevent cancer recurrence afterward. Regular eye examinations monitor tumor size and vision changes.

Investigational drugs: Darovasertib is administered orally in tablet form. It works by inhibiting certain proteins that promote cancer cell growth, potentially slowing or stopping tumor progression.

Study of Roginolisib for Patients with Advanced Uveal Melanoma

This trial tests roginolisib against other standard treatments for patients with advanced or metastatic uveal melanoma, particularly focusing on how it affects patient survival.

Inclusion criteria: Patients must be 18 years or older with confirmed advanced or metastatic ocular melanoma. They must have received at least one previous immunotherapy treatment. If HLA-A*02:01 positive, they should have been treated with tebentafusp if available. At least one lesion must be available for biopsy, and patients must have at least one measurable tumor. An ECOG performance status of 0 to 1 is required. Patients of childbearing potential must use highly effective birth control.

Exclusion criteria: Patients with different types of cancer, those unable to follow study procedures, pregnant or breastfeeding women, those who participated in another trial recently, or those with certain medical conditions that could affect study outcomes cannot participate.

Study focus: The study compares roginolisib with investigator-chosen treatments to assess overall survival rates. Roginolisib is taken orally as a tablet, while comparison treatments may include medications given through intravenous infusion. Regular monitoring includes biopsies, imaging studies, and health assessments.

Investigational drugs: Roginolisib is a targeted cancer therapy being studied for its ability to shrink tumors or stop their growth. It works by inhibiting pathways that promote tumor growth.

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

This study investigates tebentafusp, both alone and combined with pembrolizumab, for patients with advanced melanoma who have received previous treatment.

Inclusion criteria: Patients must be 18 years or older and HLA-A*02:01-positive. They must have unresectable Stage III or Stage IV non-ocular melanoma and provide a tumor tissue sample. Patients must have either measurable or non-measurable disease according to RECIST v1.1 criteria. An ECOG performance status of 0 or 1 is required. Sexually active patients of childbearing potential must use highly effective contraception and provide necessary biomarker samples.

Exclusion criteria: Patients who already received treatment for advanced non-ocular melanoma, those outside the specified age range, or those belonging to vulnerable populations cannot participate.

Study focus: The trial compares the tebentafusp regimen against investigator-chosen treatments to determine if it can reduce cancer DNA in the blood and improve survival rates. Tebentafusp and pembrolizumab are given through intravenous infusion. The study monitors participants for up to 24 months, tracking cancer markers and overall health.

Investigational drugs: Tebentafusp is an immunotherapy that helps the immune system recognize and attack cancer cells by targeting specific proteins. Pembrolizumab blocks a protein on cancer cells, allowing the immune system to better detect and destroy them. Both are immunotherapy medications given by infusion.

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

This trial examines whether tebentafusp alone can completely eliminate cancer in the liver before surgery for patients with metastatic uveal melanoma that has spread only to the liver.

Inclusion criteria: Patients must have confirmed metastatic uveal melanoma with liver metastasis that can be surgically removed, with no disease outside the liver. They must test positive for HLA-A*0201 and not have received any previous systemic treatment for advanced disease. Previous local liver treatments are not allowed, though neoadjuvant therapy for localized disease is permitted. Patients must be at least 18 years old with an ECOG performance status of 0-1 and have adequate organ function, including specific blood count and liver function requirements.

Exclusion criteria: Patients with disease outside the liver, unresectable liver tumors, those outside the specified age range, or those considered part of a vulnerable population cannot participate.

Study focus: The trial aims to achieve complete disappearance of cancer in the liver using tebentafusp before surgery. After approximately 7 months, response is evaluated through biopsy or surgical resection. If complete response is achieved, patients may continue treatment without surgery. Regular monitoring includes blood samples and imaging studies.

Investigational drugs: Tebentafusp is administered as an injection and works by helping the immune system recognize and attack cancer cells. It is classified as an immunotherapy.

Study on Melatonin for Patients with Uveal Melanoma to Prevent Metastasis

This Swedish trial investigates whether taking melatonin daily for five years can reduce the risk of cancer spreading in patients with uveal melanoma.

Inclusion criteria: Patients must be at least 18 years old with a confirmed diagnosis of uveal melanoma. The tumor must be classified as T3d or higher, or “large” according to modified COMS criteria. Specific tumor characteristics are required, including epithelioid cell type, low BAP-1 protein levels, 9 or more mitoses per 40 hpf, or a 60% or higher risk of metastasis within 5 years. Patients already taking melatonin must stop for at least two weeks before joining.

Exclusion criteria: Patients with other types of cancer, those currently receiving cancer treatment, those with severe melatonin allergies, pregnant or breastfeeding women, those unable to take oral medication, those with severe liver or kidney disease, or those who participated in another trial within 30 days cannot join.

Study focus: Participants receive 20 mg of melatonin (four 5 mg tablets) orally every evening for 5 years or a placebo. The study tracks the occurrence of cancer spread over 5 years, overall survival rates, and the risk of developing other cancers. Regular check-ups monitor health and treatment effects.

Investigational drugs: Melatonin is a naturally occurring hormone that regulates sleep-wake cycles. In this trial, it is being tested for potential antioxidant properties that may help prevent cancer spread.

Study on Melphalan, Ipilimumab, and Nivolumab for Patients with Uveal Melanoma Liver Metastases

This Swedish study compares percutaneous hepatic perfusion combined with immunotherapy medications against immunotherapy alone for patients whose uveal melanoma has spread to the liver.

Inclusion criteria: Patients must be at least 18 years old with an ECOG performance status of 0 or 1. They must have liver metastasis from uveal melanoma confirmed by tissue examination and at least one measurable disease area in the liver. Patients should not have had previous treatment for metastases, except if disease progressed after certain treatments. They must be suitable for the percutaneous hepatic perfusion procedure. Women of childbearing potential must have a negative pregnancy test and use effective birth control. Men must also agree to use contraception.

Exclusion criteria: Patients with different cancer types, those outside the specified age range, vulnerable populations, those ineligible for specific treatment groups, or those with medical conditions making participation unsafe cannot join.

Study focus: The trial evaluates whether adding percutaneous hepatic perfusion to ipilimumab and nivolumab treatment improves outcomes compared to immunotherapy alone. Ipilimumab and nivolumab are given as infusions to help the immune system fight cancer. Regular monitoring assesses disease progression, health status, and quality of life.

Investigational drugs: Ipilimumab and nivolumab are immune checkpoint inhibitors given intravenously that enhance the body’s immune response against cancer cells. Percutaneous hepatic perfusion delivers high-dose chemotherapy directly to the liver while protecting the rest of the body.

Study on Tebentafusp and Liver Radiotherapy for Patients with Metastatic Uveal Melanoma HLA A*02:01 Positive

This Italian trial examines whether adding liver-directed radiation therapy to standard tebentafusp treatment can prolong the time before cancer progresses in patients with metastatic uveal melanoma.

Inclusion criteria: Patients must have HLA-A*02:01 positive metastatic uveal melanoma with liver metastases. At least one measurable liver tumor is required, with the largest being 8 cm or smaller. Patients must be 18 years or older with an ECOG score of 0 or 1, indicating good physical function. Adequate bone marrow, kidney, and liver function is required based on specific blood test values. Patients must provide written informed consent and be able to follow the study protocol. Women of childbearing potential and men with female partners who can become pregnant must use effective birth control during the study and for at least 1 week after treatment.

Exclusion criteria: Previous treatment with certain immunotherapies targeting specific proteins, prior liver-directed therapies, active autoimmune disease requiring treatment, history of severe immune-related side effects, uncontrolled brain metastases, significant heart disease, serious infections, pregnancy or breastfeeding, known HIV or hepatitis infections, or inability to comply with study procedures.

Study focus: The study combines tebentafusp immunotherapy with hepatic radiotherapy targeting liver tumors. Regular assessments monitor cancer response, treatment effectiveness, and side effects. Blood samples are collected to analyze circulating tumor DNA and immune markers. The trial aims to determine if adding radiation therapy improves outcomes compared to tebentafusp alone.

Investigational drugs: Tebentafusp is a bispecific protein that connects T cells to melanoma cells, helping the immune system recognize and attack cancer. Hepatic radiotherapy uses radiation to target liver tumors while minimizing damage to healthy tissue.

Study on the Effectiveness and Safety of Belzupacap Sarotalocan for Patients with Small Choroidal Melanoma or Indeterminate Lesions

This multi-country trial tests belzupacap sarotalocan for patients with small choroidal melanoma or indeterminate lesions, examining whether it can slow or stop tumor growth while preserving vision.

Inclusion criteria: Patients must have a clinical diagnosis of primary indeterminate lesion or small choroidal melanoma with documented early growth and no evidence of cancer spread confirmed by imaging. They must be treatment naïve, meaning they have not received previous treatment for their condition, though photodynamic therapy more than 12 months ago may be acceptable after expert consultation. Both male and female patients can participate, including those from vulnerable populations.

Exclusion criteria: Patients with other eye diseases that could affect study results, those who had previous treatments for eye tumors, those with a history of severe allergic reactions to medications, pregnant or breastfeeding women, those with uncontrolled medical conditions, those unable to follow study procedures or attend follow-up visits, or those participating in another trial simultaneously cannot join.

Study focus: The trial compares belzupacap sarotalocan with a placebo (sham injection). The medication is injected into the suprachoroidal space of the eye using a special device. Regular monitoring assesses tumor size changes, visual acuity, and treatment safety. The primary endpoint measures time to tumor progression at Week 65.

Investigational drugs: Belzupacap sarotalocan is a targeted cancer therapy administered by eye injection. It works through photodynamic therapy, binding to cancer cells and using light activation to destroy them while sparing healthy tissue.

Comparing tebentafusp treatment versus observation in patients with high-risk eye melanoma after initial treatment

This large multi-country trial examines whether tebentafusp treatment after initial surgery or radiation therapy helps prevent cancer recurrence in high-risk uveal melanoma patients.

Inclusion criteria: Patients must be 18 years or older with primary uveal melanoma that has not spread, excluding iris melanoma, and have completed either surgery or radiation therapy. They must be considered high-risk based on either Stage III cancer or specific genetic tumor features. Primary treatment must be completed within 11 weeks before joining. Patients must be HLA-A*02:01 positive with an ECOG performance status of 0 or 1. Adequate organ function is required, including normal kidney, liver, and blood cell counts. Women who can become pregnant must have a negative pregnancy test and use effective birth control during treatment and for 6 months after. Breastfeeding women must stop breastfeeding during and for 6 months after treatment. Medical imaging must show no signs of cancer recurrence within 4 weeks before starting.

Exclusion criteria: Prior systemic treatment for uveal melanoma, history of other cancers within the past 3 years (except adequately treated non-melanoma skin cancer or cervical cancer), presence of active or untreated brain metastases, severe heart conditions, uncontrolled high blood pressure, severe liver or kidney disease, active infections, autoimmune conditions requiring systemic treatment, pregnancy or breastfeeding, known allergies to the study medication, participation in another trial within 30 days, mental conditions interfering with compliance, or any condition making the patient unsuitable.

Study focus: Patients are randomly assigned to receive either tebentafusp treatment or observation only. Those receiving treatment get KIMMTRAK infusions for up to 6 months. Regular follow-up monitors for cancer recurrence, with the study continuing until 2032.

Investigational drugs: Tebentafusp is a bispecific fusion protein that connects T-cells to melanoma cells, enabling the immune system to recognize and attack cancer cells more effectively. It is specifically designed for HLA-A*02:01-positive patients and represents a significant advancement in adjuvant treatment following primary therapy.

Study of Darovasertib and Crizotinib for Patients with HLA-A2 Negative Metastatic Uveal Melanoma

This Belgian trial tests the combination of darovasertib and crizotinib against standard treatments for patients with HLA-A2 negative metastatic uveal melanoma.

Inclusion criteria: Patients must be at least 18 years old with confirmed uveal melanoma that has spread and must be HLA-A2 negative. They should not have received previous chemotherapy or immunotherapy for advanced cancer. A tumor sample must be available for testing, and at least one measurable tumor is required. Patients must be able to safely receive and absorb the study treatment with an ECOG performance status of 0 or 1 and life expectancy of at least 3 months. Adequate organ function is required, including specific blood cell counts, normal liver and kidney function, and normal blood clotting times. Women of childbearing potential must use effective birth control during the study and for 6 months after, and men must be surgically sterile or use double barrier contraception during and for 6 months after treatment.

Exclusion criteria: Patients who do not have HLA-A2 negative metastatic uveal melanoma cannot participate.

Study focus: The study compares the darovasertib and crizotinib combination against investigator-chosen treatments to assess progression-free survival and overall survival. Both study medications are taken orally. Regular monitoring tracks treatment response, side effects, and disease progression. The treatment continues until disease progression or unacceptable side effects occur.

Investigational drugs: Darovasertib is a protein kinase inhibitor that blocks proteins involved in cancer cell growth and spread. Crizotinib is a tyrosine kinase inhibitor that targets specific proteins contributing to cancer growth. Both medications are oral agents being evaluated in combination.

Summary

The 14 ongoing clinical trials for uveal melanoma reflect the global effort to find more effective treatments for this rare eye cancer. Several notable patterns emerge from this collection of studies.

A significant concentration of trials is taking place in Spain, which hosts 9 different studies, followed by Germany and Italy with 7 trials each. Belgium, France, and the Netherlands also show substantial participation with 5-6 trials each. This geographic distribution demonstrates strong European research commitment to advancing treatment options for this condition.

The trials can be broadly categorized into three groups: studies for localized disease that has not spread, studies for metastatic disease particularly involving the liver, and prevention studies aimed at stopping cancer spread. Several medications appear across multiple trials, most notably tebentafusp, which is being tested in 4 different studies for various stages and presentations of the disease. Darovasertib appears in 3 trials, reflecting intensive investigation of this protein kinase inhibitor.

Many studies focus specifically on patients with certain genetic markers, particularly HLA-A*02:01 status, which has become an important factor in treatment selection. This personalized approach represents a significant advancement in targeting therapy to individual patient characteristics.

The trials employ diverse treatment approaches, including immunotherapies that help the immune system fight cancer, targeted therapies that block specific proteins involved in cancer growth, combination treatments using multiple medications, and innovative local treatments like liver-directed radiation or hepatic perfusion. One unique study even investigates melatonin, a naturally occurring hormone, for its potential to prevent cancer spread.

Most trials require patients to have good overall physical function, with ECOG performance status of 0 or 1 being a common requirement. This ensures participants can safely undergo treatment and complete the study protocol. The studies typically include careful monitoring through regular check-ups, imaging studies, biopsies, and blood tests to track treatment response and safety.

These ongoing clinical trials offer hope for improved outcomes for patients with uveal melanoma at all stages of the disease, from small localized tumors to cancer that has spread throughout the body.

Ongoing Clinical Trials on Uveal melanoma

  • A Study of Darovasertib Before Surgery or Radiation Therapy for Patients with Early-Stage Uveal Melanoma That Has Not Spread

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Czechia Denmark France Germany +4

  • Study on Tebentafusp and Liver Radiotherapy for Patients with Metastatic Uveal Melanoma HLA A*02:01 Positive

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Italy

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

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany Spain

  • Study of Roginolisib for Patients with Advanced Uveal Melanoma

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Italy Spain

  • Study of Darovasertib and Crizotinib for Patients with Metastatic Uveal Melanoma Who Are HLA-A2 Negative

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Germany Italy The Netherlands Poland +1

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

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Germany Ireland Italy The Netherlands +3

  • Study on Melphalan, Ipilimumab, and Nivolumab for Patients with Uveal Melanoma Liver Metastases

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Norway Sweden

  • Study on Melatonin for Patients with Uveal Melanoma to Prevent Metastasis

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Sweden

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

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium France Germany Italy Poland +1

  • A study comparing RP2 with nivolumab versus ipilimumab with nivolumab in adults with metastatic uveal melanoma not previously treated with immune checkpoint inhibitors

    Not yet recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Italy Poland Spain

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