Clinical trials on 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.

Complications

  • Vision loss: Uveal melanoma can cause partial or total loss of vision if it grows large enough to damage the eye’s structures.
  • Metastasis: The cancer can spread to other parts of the body, particularly the liver, leading to severe health issues.
  • Eye pain: As the tumor grows, it can cause increased pressure in the eye, leading to pain.
  • Enucleation: In advanced cases, removal of the eye may be necessary, resulting in significant physical and psychological impact.

Treatment Methods

  • Radiation therapy: Brachytherapy or external beam radiotherapy to target and kill cancer cells.
  • Surgery: Procedures such as enucleation (removal of the eye) or local resection to remove the tumor.
  • Laser therapy: Techniques like transpupillary thermotherapy (TTT) to destroy the tumor with heat.
  • Immunotherapy: Use of medications that stimulate the immune system to fight cancer cells, particularly in metastatic cases.

Prognosis

The prognosis for uveal melanoma depends on the size and location of the tumor, as well as whether the cancer has spread. Early detection and treatment can improve outcomes significantly. If the cancer is localized, the chances of successful treatment are higher. However, once the cancer has metastasized, especially to the liver, the prognosis becomes poorer, with a lower survival rate. Regular follow-ups and monitoring are crucial for managing the disease and its potential complications.
  • CT-EU-00120420

    Testing Tislelizumab and Spartalizumab for Various Cancers with High PD1 Levels

    This study focuses on the treatment of various types of cancer, including colorectal cancer, melanoma, anal carcinoma, mesothelioma, triple-negative breast cancer, lung adenocarcinoma, cholangiocarcinoma, cervical carcinoma, kidney clear cell carcinoma, stomach adenocarcinoma, esophageal adenocarcinoma, uterine adenocarcinoma, head and neck squamous cell carcinoma, sarcoma, lung squamous cell carcinoma, urothelial carcinoma, thyroid carcinoma, hepatocellular carcinoma, uveal melanoma, HER2-positive breast cancer, pancreatic adenocarcinoma, squamous esophageal carcinoma, epithelial ovarian cancer, uterine carcinosarcoma, small cell lung cancer, hormone receptor positive/HER2-negative breast cancer, lung adenocarcinoma with EGFR mutation or ALK translocation, colorectal adenocarcinoma, prostate adenocarcinoma, carcinoma of unknown primary, and other histologies.

    The therapy involves two drugs: Spartalizumab and Tislelizumab. Spartalizumab is administered at a dose of 400 mg intravenously every 28 days, while Tislelizumab is administered at a dose of 300mg intravenously every 28 days.

    The purpose of this study is to evaluate the effectiveness of these drugs in patients with tumors that express high levels of a protein called PD1 or lower levels in which PD1/PD-L1 inhibitors have been previously established to be effective. PD1 is a protein found on the surface of cells that helps keep the body’s immune responses in check and blocks cancer-fighting immune cells.

    The study is divided into three groups, called cohorts. Patients will first sign a consent form to allow a molecular test to determine the PD1 levels of their tumor. Patients with high PD1-expressing tumors will be placed into cohort 1 or cohort 3. Those with low PD1-expressing tumors, where the effectiveness of similar treatments has been previously established, will be placed into cohort 2.

    – Cohort 1 will receive Spartalizumab as monotherapy (single drug treatment).
    – Cohort 2, consisting of patients with PD1-low tumors, will also receive Spartalizumab as monotherapy.
    – Cohort 3 will receive Tislelizumab as monotherapy.

    Frequent evaluations will be conducted to monitor the patient’s response to the treatment. Participants will receive the drugs intravenously (through a vein) every 28 days and will be closely observed for any improvements or potential side effects.

    • Spartalizumab
    • Tislelizumab
  • Tebentafusp for the treatment of recurrent melanoma

    The study aims to investigate a new treatment for patients with cutaneous melanoma or uveal melanoma after surgery. Researchers want to see if a new drug called tebentafusp can help these patients live longer.

    Tebentafusp is a new drug that has already been studied in patients with advanced melanoma of the skin and uvea. In this study, this medicine will be administered to patients whose disease has relapsed at the molecular level using a special blood test. Patients will receive tebentafusp for up to 6 months as an intravenous infusion once a week and will then be followed for 12 months to check whether the disease has returned.

    • tebentafusp
  • Long-term melatonin intake and evaluation of the effect on melanoma patients

    The aim of this study is to test a new treatment for an eye cancer called uveal melanoma. This cancer can spread to other parts of the body, and once it does, it is extremely difficult to treat. Therefore, the aim of this study is to test whether melatonin for 5 years after the initial cancer diagnosis can help prevent or delay the spread of cancer.

    Half of the study participants will take melatonin tablets (20 mg) at bedtime every day for 5 years, and the other half will take nothing. Researchers will monitor both groups closely, checking for any signs of spread of the cancer with regular imaging and blood tests.

    • Melatonin
  • Study of pembrolizumab in combination with lenvatinib in the treatment of metastatic uveal melanoma

    This study aims to evaluate a new combination of two anticancer drugs: pembrolizumab and lenvatinib in the treatment of metastatic uveal melanoma. The study is divided into two groups of patients – those who have not previously received tebentafusp and those who have already been treated with it. Doctors suspect that the benefits of anticancer drugs in patients with metastatic uveal melanoma may vary depending on prior exposure to Tebentafusp.

    Participants will receive pembrolizumab for up to 35 cycles, as well as lenvatinib, until disease progression or serious side effects occur. The study aims to assess progression-free survival after 27 weeks of treatment. Regular imaging tests, such as MRI of the liver and CT scan of the chest, abdomen and pelvis, will be performed every 9 weeks to monitor your response to treatment. After completion of treatment, patients will be followed to assess overall survival.

    • Pembrolizumab
  • Infusion of tumor-infiltrating lymphocytes into the liver of melanoma patients with liver metastases

    This is a clinical trial for a new type of treatment — tumor-infiltrating lymphocytes (TIL). This study will test whether this treatment can help fight melanoma that has spread to the liver. Tumor infiltrating lymphocytes (TILs) are immune system cells that accumxulate around and inside the tumor. They can recognize and attack cancer cells, as well as prevent cancer cells from spreading to other organs. Scientists plan to multiply them in the laboratory and then introduce them back into the patient’s body through the main artery supplying the liver.

    Before this, patients will receive a single dose of melphalan chemotherapy to help prepare their body. After lymphocyte infusion (TIL), patients will also receive interleukin-2, a protein that helps lymphocytes do their job better. The goal is to see if this treatment is safe and effective. Doctors will watch closely for any side effects or serious problems that may arise during treatment.

    • Melphalan
    • Interleukin-2
    • Autologous Tumor Infiltrating Lymphocytes
  • Treatment with Bel-Sar for patients with uveal melanoma

    The aim of this clinical trial is to test a new drug called Belzupacap Sarotalocan, or Bel-sar for short, for people with uveal melanoma.

    The main aim of this study is to test whether bel-sar is safe and effective compared to a dummy treatment, which acts as a placebo. The Bel-sar treatment involves injecting the drug (microinjection) into the eye space and then activating it with a special laser.

    The most important thing researchers want to know is how long it takes for the tumor to start growing again after treatment with bel-sar compared with sham treatment. They will closely monitor participants for up to 52 weeks to see how the situation progresses.

    • Placebo
    • Belzupacap Sarotalocan
  • Study of darovasertib in patients with uveal melanoma

    This is a study of a new drug called darovasertib (also known as IDE196 or LXS196) in patients with primary choroidal melanoma. Darovasertib is an oral, potent and selective protein kinase C inhibitor that will be used to treat uveal melanoma.

    The aim of this study is to see if darovasertib can help reduce the size of the tumor before local treatment, such as removal of the eyeball or radiation. Patients will receive darovasertib for a maximum of 6 months before local treatment, and then for a further 6 months after local treatment. Doctors will watch to see if the drug helps avoid having to remove the eyeball or reduce the dose of radiation needed to treat the tumor.

    It is important to monitor for any side effects and changes in laboratory tests while taking darovasertib. Doctors will closely monitor the patient’s health throughout the study, which may last up to 3 years.

    • Darovasertib
  • Study of a new drug – DYP688 for patients with uveal melanoma and other melanomas with the GNAQ/11 mutation

    This study is testing a new drug called DYP688 for people with metastatic uveal melanoma. It is a type of eye cancer that has spread to other parts of the body. Other types of cutaneous melanoma that have certain gene mutations called GNAQ/11 are also being studied.

    The process consists of two main parts. The first part, called the dose escalation phase, aims to find the highest safe dose of DYP688 that can be given without too many side effects. This section includes patients with metastatic uveal melanoma and other melanomas with a GNAQ/11 mutation.

    Once the right dose is determined in the second part, called Phase II, DYP688 will be tested in three groups of patients: people with metastatic uveal melanoma who have previously received another medicine called tebentafusp, people with metastatic uveal melanoma who has not received tebentafusp before, and the third group with melanomas with the GNAQ/11 mutation.

    The main goal is to see how well DYP688 works at reducing or stopping the development of these cancers and to see if there are any serious side effects.

    • DYP688
  • Study of DYP688 in patients with metastatic uveal melanoma

    The aim of this study is to test a new drug combination to treat metastatic uveal melanoma, a type of cancer that starts in the eye and spreads to other parts of the body. The main drugs being tested are IDE196 (also called darovasertib) and crizotinib, both taken by mouth twice daily.

    Currently, this process is divided into several stages. In the first part, investigators will test two different doses of IDE196 in combination with crizotinib and compare them to other approved therapies such as pembrolizumab, ipilimumab + nivolumab, or dacarbazine. Once they determine the best dose of IDE196, they will move to the next step in which everyone will receive that dose along with crizotinib or one of the other treatments.

    Researchers will primarily look at how long the cancer stays under control without getting worse and how long patients live. It could take about 4 years to get all the answers you need.

    • Darovasertib/IDE196
    • Dacarbazine
    • Nivolumab
    • Crizotinib
    • Ipilimumab
    • Pembrolizumab