Clinical trials on Melanoma

Melanoma is a type of skin cancer that begins in the melanocytes, the cells that produce the pigment melanin responsible for skin color. It is known for its ability to spread to other parts of the body if not treated early. Early detection and treatment are crucial for improving outcomes.

Complications

  • Metastasis: Melanoma can spread to other parts of the body, including the lymph nodes, lungs, liver, brain, and bones, leading to severe health issues.
  • Organ damage: If melanoma spreads to vital organs, it can impair their function and lead to life-threatening conditions.
  • Neurological effects: When melanoma spreads to the brain, it can cause headaches, seizures, and neurological deficits.
  • Lymphedema: If lymph nodes are affected or removed, it can lead to swelling and fluid retention in limbs.

Treatment Methods

  • Surgery: Removal of the melanoma and surrounding tissue is the primary treatment for early-stage melanoma.
  • Immunotherapy: Drugs like nivolumab and pembrolizumab stimulate the immune system to attack cancer cells.
  • Targeted therapy: Medications that target specific genetic mutations in melanoma cells, such as BRAF inhibitors.
  • Radiation therapy: High-energy rays are used to kill cancer cells, often used for melanoma that has spread.
  • Chemotherapy: Uses drugs to kill cancer cells, though less common now due to newer targeted treatments.

Prognosis

The prognosis of melanoma varies based on the stage at diagnosis. Early-stage melanoma, when detected and treated promptly, has a high survival rate. Advanced melanoma with metastasis has a lower survival rate but can still be managed with current therapies to extend life and improve quality of life. Regular follow-ups and monitoring are essential to manage potential recurrences or complications.
  • CT-EU-00121729

    Safety and efficacy study of BA3021 for patients with lung cancer, breast cancer, melanoma, or head and neck cancer

    This clinical trial targets various types of cancer such as Non-Small Cell Lung Cancer (NSCLC), Triple Negative Breast Cancer (TNBC), Melanoma, and Head and Neck Cancer. The therapy being assessed involves BA3021 (CAB-ROR2-ADC), a specialized drug designed to target cancer cells. Another drug, a PD-1 inhibitor, will also be used in one part of the study.

    The primary goal of this study is to evaluate the safety and effectiveness of BA3021, alone or in combination with a PD-1 inhibitor, in treating advanced solid tumors.

    This trial will be carried out in two phases:
    Phase 1 will focus on understanding the appropriate dose and its safety, while
    Phase 2 will evaluate how well the drug works alone or together with the PD-1 inhibitor.

    Participants will receive either BA3021 alone or BA3021 in combination with the PD-1 inhibitor. They will be monitored closely throughout the study to track their health and the drug’s effects on their cancer.

  • 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
  • Testing Vemurafenib and Cobimetinib for BRAF Positive Cancers

    This clinical trial is for patients with cancers that have a specific change in their cancer cells known as BRAF V600 mutation. It uses two drugs, vemurafenib and cobimetinib, to see if they can effectively treat various types of cancers such as solid tumors, haematological malignancies, melanoma, thyroid cancer, ovarian neoplasms, colorectal neoplasms, laryngeal neoplasms, non-small-cell lung carcinoma, glioma, multiple myeloma, and Erdheim-Chester disease. The purpose of this study is to determine if these drugs can help treat cancers with the BRAF V600 mutation.

    In the study, participants will receive both drugs until their disease progresses, they experience unacceptable side effects, or they decide to withdraw. Blood samples will be collected at different times during the treatment for research purposes. Participants will be monitored every three months for two years after completing the treatment.

    • Vemurafenib
    • Cobimetinib
  • 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
  • To evaluate a combination of 3 different drugs versus 2 other drugs in the treatment of patients with melanoma

    This study compares two different approaches to treating advanced melanoma, a type of skin cancer that has spread to other parts of the body. This study is specifically aimed at patients with a gene mutation called BRAF who have previously received treatment with drugs such as nivolumab or pembrolizumab.

    One therapeutic approach involves taking three study drugs: pembrolizumab administered intravenously every 3 weeks, along with encorafenib and binimetinib taken orally daily at home. The second approach involves taking two study drugs: ipilimumab and nivolumab administered intravenously every 3 weeks for the first 4 doses, followed by nivolumab alone every 4 weeks. Both treatments will last for approximately 2 years, but there is no time limit for treatment with encorafenib and binimetinib.

    The research team will closely monitor the patients’ health during regular clinic visits to see how they are responding to treatment. The main goal is to determine which treatment method is more effective in shrinking or eliminating melanoma tumors.

    • Nivolumab
    • Ipilimumab
    • Binimetinib
    • Encorafenib
    • Pembrolizumab
  • 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
  • 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
  • A study comparing biosimilar nivolumab and nivolumab in the treatment of resected melanoma

    The aim of this study is to test whether a new drug called ABP 206 (biosimilar nivolumab) works as well as the approved cancer drug OPDIVO® (nivolumab) in people with advanced cutaneous melanoma that has been surgically removed. The study divided people into 3 groups: one group will receive ABP 206, the second will receive real OPDIVO® approved in the US, and the third will receive the version of OPDIVO® approved in Europe. All of these medicines will be given through an intravenous drip every 4 weeks for up to 1 year, or until the cancer comes back or gets significantly worse.

    The main goal is to check whether ABP 206 (biosimilar nivolumab) is absorbed and maintained in the body in the same way as OPDIVO®. Researchers will also closely monitor how well it works, what the side effects are, and whether the body produces antibodies against it. The entire study will last approximately 13 months for each person joining.

    • Nivolumab biosimilar
    • Nivolumab
  • Safety and efficacy of pembrolizumab in combination with investigational drugs in the first-line treatment of patients with melanoma

    The aim of this study is to test new experimental treatments for melanoma, which is a type of skin cancer. The main goal is to test whether these new treatments are safe and effective when used alone or in combination with the drug pembrolizumab.

    The current study includes several different treatment groups. Some groups receive pembrolizumab in combination with other investigational drugs such as vibostolimab, quavonlimab, lenvatinib, favezelimab, or Tretynoina (ATRA). Other groups simply receive pembrolizumab alone.

    Scientists will carefully look at factors such as dose-limiting toxicities and adverse events to make sure the treatment is safe. They will also check the effectiveness of the therapy by measuring, for example, the objective response rate, which shows whether tumors are shrinking or disappearing.

    • Tretynoina
    • Vibostolimab
    • Quavonlimab
    • Favezelimab
    • Pembrolizumab
    • Lenvatinib
  • Study on combining two drugs – Fianlimab and Cemiplimab in patients with previously untreated melanoma

    This study examines two drugs, fianlimab and cemiplimab, given together for the treatment of melanoma. The main goal is to see how effective this drug combination is in treating melanoma compared with pembrolizumab, which is already approved for the treatment of melanoma in adults. The study will also look at whether there are any differences in the effects of these experimental drugs in adolescents and adults.

    Scientists also want to learn about other key issues: what side effects may occur from taking these experimental drugs, how much of the drugs enter the bloodstream over time, and whether the body produces antibodies to the drugs that could make them less effective or cause side effects. They will also check whether taking medications improves patients’ quality of life. Fianlimab and cemiplimab will be administered by intravenous infusion, and pembrolizumab will be administered by intravenous infusion.

    • placebo
    • Fianlimab
    • Cemiplimab
    • Pembrolizumab
  • Study of melanoma patients using cell therapy – ATL001

    This is a study to test a cell therapy called ATL001 in melanoma patients. ATL001 consists of immune cells taken from the patient that can recognize and attack cancer cells. The study consists of two parts:

    First, part of the cancer tissue will be removed to produce ATL001 specifically for the patient. The subject will then receive chemotherapy to temporarily suppress the immune system before being infused with ATL001 cells. This makes it easier for ATL001 cells to find and fight cancer cells.

    The main goal is to evaluate the safety of ATL001 and any side effects that may occur. The study will also test whether ATL001 can help shrink or control melanoma. The patient will be monitored closely for 24 months after receiving ATL001, and then followed for at least 5 years to detect any long-term effects.

    • Niwolumab
    • ATL001
  • Study of a new drug – RO7247669 for patients with untreated melanoma

    The aim of this study is to investigate a new drug called RO7247669 for people suffering from melanoma, which is a type of skin cancer that has spread and cannot be surgically removed. The main goal is to see how well this drug works at stopping the cancer from growing and spreading, which is called progression-free survival. Researchers will give different doses of the drug through a drip every 3 weeks to find the best dose.

    Currently, this drug is still being tested, so researchers will be closely watching for any side effects or problems that may arise while taking the drug. They will also look at how the drug moves through the body, something they call pharmacokinetics.

    • RO7247669
  • Study of the drug combination mRNA-4157/V940 and Pembrolizumab in the treatment of melanoma

    The aim of this clinical trial is to test whether a new drug called mRNA-4157/V940 in combination with pembrolizumab can help prevent the recurrence of melanoma in people who have already had it. Currently, mRNA-4157/V940 is what is called “individualized neoantigen therapy,” which means it is a therapy created specifically for each patient based on their cancer cells. Doctors give this drug along with pembrolizumab, a drug that helps the immune system fight cancer cells.

    The main goal of this study is to determine whether taking V940 and pembrolizumab together is more effective in preventing melanoma recurrence than taking pembrolizumab alone. Researchers will closely monitor how long it takes for the cancer to return or spread. The study will last for approximately 74 months.

    • mRNA-4157/V940
    • placebo
    • Pembrolizumab
  • Comparing methods of medication delivery for melanoma patients: A study on nivolumab and relatlimab treatments

    This clinical trial investigates treatment options for patients with advanced melanoma, comparing subcutaneous and intravenous administration of nivolumab and a fixed-dose combination of nivolumab and relatlimab. The study is designed to determine which method of administration is preferred by patients. Participants will receive either nivolumab alone or in combination with relatlimab, with treatment methods alternating between subcutaneous and intravenous routes. The trial aims to assess not only the safety and effectiveness of these treatments but also gather comprehensive data on patient experiences and preferences regarding the two methods of drug administration. The study will involve regular monitoring and assessments to evaluate treatment outcomes and any potential side effects.

    • rHuPH20
    • Relatlimab
    • Nivolumab