Clinical trials on Advanced Melanoma

Melanoma is a type of skin cancer that begins in the cells called melanocytes, which produce the pigment that gives skin its color. When melanoma is described as “advanced,” it means the cancer has spread beyond the original site to other parts of the body. This stage of melanoma is also known as metastatic melanoma. The spread of cancer makes it more challenging to treat and manage. Complications
  • Metastasis: Cancer cells can spread to other organs such as the liver, lungs, brain, and bones, leading to serious health issues.
  • Organ Dysfunction: When melanoma spreads to major organs, it can impair their function. For example, if it spreads to the liver, it can cause liver failure.
  • Neurological Issues: If melanoma reaches the brain, it can cause seizures, headaches, and other neurological problems.
  • Bone Damage: Metastasis to the bones can result in fractures and severe pain.
  • Lymphatic System Involvement: Cancer can spread through the lymphatic system, causing swelling and affecting immune function.
  • Skin Ulceration: Tumors can cause the skin to break down, leading to infections and non-healing wounds.
Treatment Methods
  • Surgery: Removal of tumors is a common approach, especially if melanoma is detected early.
  • Immunotherapy: Medications like checkpoint inhibitors (e.g., pembrolizumab, nivolumab) help the immune system recognize and attack cancer cells.
  • Targeted Therapy: Drugs targeting specific genetic changes in melanoma cells (e.g., BRAF inhibitors like vemurafenib and MEK inhibitors like trametinib) are used.
  • Chemotherapy: While less common now, it involves using drugs to kill cancer cells, usually when other treatments are not suitable.
  • Radiation Therapy: This uses high-energy rays to destroy cancer cells, often used when melanoma has spread to the brain or bones.
Prognosis The prognosis for advanced melanoma varies widely depending on several factors, including how far the cancer has spread and how well it responds to treatment. Without treatment, advanced melanoma can rapidly progress and lead to life-threatening complications. However, with current treatments, many patients experience significant improvement and prolonged survival. Immunotherapy and targeted therapies have improved the outlook for many patients, sometimes leading to long-term remission. Regular monitoring and follow-up are essential to manage and treat any recurrence of the disease effectively.
  • CT-EU-00117814

    Study comparing the new drug combination Nurulimab + Prolgolimab with standard therapy in the treatment of advanced melanoma

    The aim of this study is to test a new drug combination called BCD-217 (consisting of nurulimab and prolgolimab) against prolgolimab alone. The goal is to see if the combination works better than prolgolimab alone as first-line treatment in people with unresectable melanoma or metastatic melanoma.

    Half of the patients will receive BCD-217 for the first four doses, followed by prolgolimab alone. The other half will receive prolgolimab alone from the beginning. The most important thing researchers will focus on is the time it takes for the tumor to start growing again, which they call progression-free survival. They will be watching this closely for up to 24 months.

    Additionally, researchers will check whether these drugs are safe to use. This is a double-blind study, which means neither participants nor researchers know exactly who is receiving what treatment. This way, the test result will be completely unbiased.

    • Nurulimab + Prolgolimab
    • Placebo
    • Prolgolimab
  • Intravenous treatment with ANV419 — a new therapy for patients with advanced melanoma

    The aim of this clinical trial is to test a new combination treatment for advanced melanoma. The treatment involves taking special immune cells called tumor-infiltrating lymphocytes (TILs for short) from a patient’s tumor and growing them in the laboratory. These TILs are then returned to the patient via intravenous infusion along with a new drug called ANV419.

    ANV419 is designed to help TILs grow and multiply even more once they are back in the patient’s body. Researchers predict that these special TIL cells will be able to better recognize and attack cancer cells, helping the patient’s immune system fight melanoma.

    Doctors will closely monitor any side effects patients experience with the new therapy. They will check whether any adverse events occur, and if they do occur, how often they occur and how serious they may be. The entire study will last about a year, with regular follow-up visits to monitor the effectiveness of the treatment and the patient’s well-being.

    • Tumor-infiltrating lymphocytes (TILs)
    • ANV419
  • Study assessing the effectiveness of Tebentafusp administered alone and in combination with Pembrolizumab in the treatment of advanced melanoma

    The aim of this study is to test new treatments for people with advanced skin melanoma that does not respond well to other therapies. The main focus was on a new experimental drug called tebentafusp, which is a special type of protein that helps the body’s immune system recognize and attack cancer cells.

    The study divided patients into three different groups. One group will receive tebentafusp alone. Another group will receive tebentafusp in combination with another immunotherapy drug called pembrolizumab. The third group will receive the treatment that the doctor thinks is best for the patient – this could be another experimental drug, standard therapy, or simply supportive care.

    Scientists are primarily focusing on the effectiveness of these treatments in shrinking tumors and extending patient survival. They will also monitor closely for any side effects to make sure the treatment is safe. The study is expected to last about two years and will include frequent check-ins to monitor patient responses.

    • Tebentafusp
    • Pembrolizumab