Clinical trials on Metastatic Melanoma

Metastatic melanoma is an advanced form of skin cancer that occurs when melanoma cells spread from the original tumor site to other parts of the body. This type of melanoma can affect various organs, such as the lungs, liver, brain, and bones, leading to significant health challenges. The spread of melanoma makes treatment more complex and requires comprehensive medical care. Complications:
  • Organ Dysfunction: When melanoma spreads to vital organs like the lungs, liver, and brain, it can impair their function, leading to respiratory issues, liver failure, or neurological problems.
  • Chronic Pain: Tumor growth and metastasis can cause severe and persistent pain, significantly affecting the patient’s quality of life.
  • Lymphatic Obstruction: The spread of melanoma to lymph nodes can cause lymphedema, resulting in swelling and discomfort in affected areas.
  • Neurological Issues: Metastasis to the brain can lead to cognitive impairments, seizures, and other serious neurological deficits.
  • Bone Fractures: Metastasis to the bones increases the risk of fractures and severe pain, impacting mobility and overall health.
  • Cachexia: Progressive weight loss and muscle wasting can occur, leading to overall physical decline and weakness.
Treatment Methods:
  • Immunotherapy: Uses drugs like pembrolizumab, nivolumab, and ipilimumab to boost the immune system’s ability to fight cancer cells.
  • Targeted Therapy: Involves medications such as vemurafenib, dabrafenib, and trametinib that target specific genetic mutations within melanoma cells.
  • Chemotherapy: Utilizes drugs like dacarbazine and temozolomide to kill rapidly dividing cancer cells.
  • Radiation Therapy: Employs high-energy radiation to destroy cancer cells and shrink tumors, often used for brain metastases.
  • Combination Therapy: Combines different treatments, such as targeted therapy and immunotherapy, to enhance effectiveness.
Prognosis: The prognosis for metastatic melanoma varies depending on the stage of the disease and the effectiveness of the treatments used. With advanced therapies, many patients experience improved survival rates and better quality of life. However, the disease remains serious and can be life-threatening if not managed properly. Without treatment, metastatic melanoma can progress rapidly, leading to significant health deterioration and reduced life expectancy. Early detection and aggressive treatment are crucial for improving outcomes and extending survival.
  • 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
  • A study on the use of the new drug NX-1607 for patients with advanced types of various cancers

    The main goal of this study is to test the safety and effectiveness of a new drug called NX-1607 in the treatment of various types of advanced cancers. NX-1607 is taken orally and works by blocking a protein called Cbl-b.

    The study consists of two parts. The first part, called Phase 1a, will study different doses of NX-1607 alone or in combination with paclitaxel to find the highest safe dose. This section includes patients with cancers such as ovarian, stomach, head and neck, melanoma, lung, prostate, mesothelioma, breast, bladder, cervical, colorectal and lymphoma.

    In the second part, called Phase 1b, selected doses from Phase 1a will be administered to separate groups of patients with the same type of cancer. The main goal is to see if NX-1607, alone or with paclitaxel, can shrink or control tumors. Patient safety will be continuously monitored by researchers.

    The goal of this study is to find the right dose of the experimental drug NX-1607 and see if it has promising anti-cancer effects in a variety of advanced cancers for which treatment options are limited. Patient safety is the highest priority throughout the entire examination.

    • NX-1607
    • Paclitaxel
  • Study ANV419 as monotherapy or in combination with pembrolizumab and ipilimumab in patients with metastatic melanoma

    The aim of this study is to test a new drug called ANV419. It will be given alone or in combination with other approved cancer medicines such as pembrolizumab or ipilimumab. The main goal is to see how well ANV419 works and whether it is safe for people with advanced cutaneous melanoma, which is a type of skin cancer that has spread or cannot be surgically removed.

    The trial is currently open to adult patients who have already been treated with drugs that target PD-1 or PD-L1 proteins, but whose cancer has continued to progress. The study will have different parts. First, doctors will find the right dose of ANV419 to use alone or in combination with other treatments. They will then check how many patients respond to treatment, which means their tumors shrink or stop spreading.

    • ANV419
    • Ipilimumab
    • Pembrolizumab
  • Testing of a new antibody (RO7247669) in patients with metastatic cancers

    This clinical trial is testing a new drug called RO7247669. This is a special type of antibody that targets two proteins in cancer cells, PD-1 and LAG-3. The goal is to see if this new drug can help fight advanced or metastatic solid tumors such as melanoma, lung cancer and esophageal cancer.

    In the first part of the study, researchers will administer different doses of RO7247669 to patients every 2 or 3 weeks through a drip. They will watch closely for any side effects and toxicities that may occur. Once they determine the highest safe dose, they will move on to the next section.

    In the second part, they will give the highest safe dose to more patients with a specific type of cancer. The most important thing they will look for will be how well the drug works against the tumors, such as whether they shrink for a while or stop growing. They will also monitor you for any side effects for up to 2 years.

    The aim of this study is to find the best and safest dose of this new dual-acting antibody drug and whether it will be able to effectively fight advanced solid tumors.

    • RO7247669
  • Personalized T-cell therapy (NEO-PTC-01) for the treatment of patients with unresectable melanoma or metastatic melanoma

    This clinical trial aims to investigate the safety and activity of NEO-PTC-01, which is an autologous personalized T-cell (PTC) product for adoptive cell therapy. Adoptive cell therapy is a type of immunotherapy that uses cells from a patient’s immune system to fight diseases such as cancer. This therapy involves isolating, modifying and multiplying specific immune cells and then administering them to the patient. NEO-PTC-01 is produced outside the body and targets neoantigens displayed on and within the patient’s tumor.

    The study will be conducted in two parts: Part 1 (dose finding) and Part 2 (dose expansion). Two doses of NEO-PTC-01 will be tested in the dose finding portion. Additionally, interleukin (IL)-2 administration and anti-PD-1 antibody therapy are planned.

    Researchers will primarily observe how many patients experience any side effects or adverse events, whether they are mild or serious. To ensure patient safety, they will be under constant care of specialists.

    • An Anti-Programmed Death-1 Antibody (αPD-1)
    • NEO-PTC-01
    • IL-2
  • A study comparing the combination of lifileucel plus pembrolizumab with pembrolizumab alone in the treatment of unresectable, advanced melanoma

    The aim of this study is to test a new treatment for people with advanced melanoma, a serious form of skin cancer that has spread to other parts of the body. The new treatment combines two different therapies: lifileucel, made from the patient’s own immune cells called tumor-infiltrating lymphocytes, and pembrolizumab, a type of immunotherapy drug that helps the body’s immune system fight cancer.

    The study will compare the effectiveness and safety of this combination treatment with pembrolizumab alone. Patients who initially received only pembrolizumab and whose cancer worsened will have the option to switch treatment and receive lifileucel monotherapy.

    The main goals of the study are to see whether the combination treatment can improve the objective response rate, which measures how many patients have had their tumors shrink, and progression-free survival, which is how long patients live without their cancer getting worse. To evaluate the results of the study, patients will be followed for up to 5 years.

    To be eligible for this trial, patients must have advanced melanoma that cannot be surgically removed or has spread to other organs. Additionally, patients cannot be previously treated for metastatic disease, although some prior therapies for earlier stages of melanoma are permitted.

    • Lifileucel
    • Pembrolizumab
  • To evaluate the effectiveness of nivolumab used alone and in combination with HBI-8000 in the treatment of unresectable or metastatic melanoma

    This is a study comparing two treatment options for patients with melanoma that cannot be surgically removed or has spread to other parts of the body. One treatment option is an investigational drug called Tucidinostat (HBI-8000) taken by mouth twice a week in combination with an approved drug called nivolumab given by intravenous infusion. Another option is a placebo taken orally twice a week, also in combination with nivolumab given by intravenous infusion.

    The primary goal of the study is to determine whether the combination of HBI-8000 and nivolumab is more effective than nivolumab alone in shrinking the tumor or preventing further tumor progression. The study will also assess the safety of the treatment combinations.

    Patients enrolled in the main study will be randomly assigned to receive either the HBI-8000 combination or a placebo combination. Treatment will continue for up to 2 years or until the cancer progresses, side effects worsen or the patient decides to withdraw from the study. The study will last up to 4 years and will include regular monitoring and follow-up visits.

    • Placebo
    • Tudicdinostat/HBI-8000