Clinical trials on Unresectable Melanoma

Unresectable melanoma is a form of skin cancer that cannot be removed surgically due to its size, location, or extent of spread. This type of melanoma often involves advanced stages of the disease where the cancer has spread to other parts of the body, making surgical removal impractical or impossible. It requires alternative treatment approaches to manage the disease and improve patient outcomes. Complications:
  • Metastasis: The spread of cancer cells to other organs such as the lungs, liver, brain, and bones, leading to organ dysfunction and failure.
  • Chronic Pain: Persistent pain caused by tumor growth and metastasis, affecting quality of life.
  • Lymphedema: Swelling due to lymphatic obstruction, often resulting from the spread of melanoma to lymph nodes.
  • Neurological Issues: Cognitive impairments, seizures, and other neurological deficits if the cancer spreads to the brain.
  • Respiratory Problems: Difficulty breathing and reduced lung function if melanoma spreads to the lungs.
  • Liver Dysfunction: Jaundice and other liver-related issues if the cancer affects the liver.
  • Bone Fractures: Increased risk of fractures and severe pain if cancer spreads to the bones.
Treatment Methods:
  • Immunotherapy: Uses drugs like pembrolizumab, nivolumab, and ipilimumab to stimulate the immune system to attack cancer cells.
  • Targeted Therapy: Involves drugs like vemurafenib, dabrafenib, and trametinib that target specific genetic mutations within cancer cells.
  • Chemotherapy: Utilizes drugs such as dacarbazine and temozolomide to kill rapidly dividing cancer cells.
  • Radiation Therapy: Uses high-energy radiation to destroy cancer cells and shrink tumors, often used for brain metastases.
  • Combination Therapy: Combines two or more treatments, such as targeted therapy and immunotherapy, to increase effectiveness.
Prognosis: The prognosis for unresectable melanoma varies based 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, melanoma can rapidly progress, leading to significant health deterioration and reduced life expectancy. Early detection and aggressive treatment are critical 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
  • 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