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Ongoing Clinical Trials for Malignant Melanoma

This article provides detailed information about 71 ongoing clinical trials for malignant melanoma, a serious form of skin cancer. These trials are testing various treatments including immunotherapies, targeted therapies, cell therapies, and combination approaches across multiple countries in Europe and beyond.

Clinical trial locations

Long-Term Safety Study of MB-CART19.1, MB-CART20.1, and Zamtocabtagene Autoleucel for Patients with Advanced Melanoma or B-Cell Malignancies

This clinical trial focuses on the long-term safety monitoring of patients treated with Miltenyi cell and gene therapies. The study includes patients with stage III or IV melanoma that cannot be surgically removed.

Main inclusion criteria: Patients must have received Miltenyi CAR T cell therapy at least 12 months before joining this follow-up study. They must have recovered from previous treatment side effects and have adequate organ function. Patients must provide informed consent and be willing to follow study procedures.

Main exclusion criteria: Patients with other types of cancer not specified in the study, those who have not relapsed or whose cancer is not resistant to treatment, and patients unable to follow study procedures are excluded.

Trial focus: The study aims to evaluate the long-term safety of Miltenyi CAR T cell therapies by monitoring for late-onset side effects, serious health events, and cancer recurrence. Regular follow-up visits will include assessments of health status, blood tests, and monitoring for the presence of remaining modified cells from the therapy. The study will track disease progression and overall survival rates.

Investigational drugs: Miltenyi CAR T Cell Therapy uses the patient’s own immune cells modified to target and destroy cancer cells. The therapy involves collecting T cells from the patient, altering them to produce chimeric antigen receptors on their surface, and then infusing them back into the patient to enhance the body’s natural ability to fight cancer.

Study of brenetafusp with nivolumab compared to nivolumab alone in adults with untreated advanced melanoma who are HLA-A*02:01-positive

This trial compares two treatments for advanced melanoma: brenetafusp combined with nivolumab versus nivolumab alone. Participants must have the HLA-A*02:01 genetic marker and advanced melanoma that cannot be surgically removed or has spread to other parts of the body.

Main inclusion criteria: Patients must be HLA-A*02:01-positive, have unresectable or metastatic melanoma, and have measurable disease according to RECIST guidelines. They must have adequate organ function, an ECOG performance status of 0 or 1, and be willing to provide tumor tissue samples. Female patients of childbearing potential must have a negative pregnancy test and use effective contraception.

Main exclusion criteria: Patients with other types of cancer, severe medical conditions, active infections, pregnancy or breastfeeding, known allergies to study medications, recent major surgery, or active autoimmune diseases are excluded.

Trial focus: The study evaluates whether adding brenetafusp to nivolumab improves progression-free survival compared to nivolumab alone. Participants receive treatment through intravenous infusion, with regular monitoring of health status and tumor response using imaging tests. The trial measures how long patients live without disease progression and assesses safety and side effects.

Investigational drugs: Brenetafusp is a bispecific fusion protein targeting specific melanoma markers. Nivolumab is an established immunotherapy that blocks the PD-1 protein on immune cells, allowing them to better attack cancer cells. Both are administered through IV infusion.

Study of BT-001 and Pembrolizumab for Patients with Advanced Solid Tumors, Including Sarcoma, Merkel Cell Carcinoma, Melanoma, Breast, and Lung Cancer

This trial tests BT-001, an oncolytic virus injected directly into tumors, alone and in combination with pembrolizumab immunotherapy. The study includes patients with melanoma among other advanced solid tumors.

Main inclusion criteria: Patients must be 18 years or older with at least one measurable and injectable tumor lesion. They must have an ECOG performance status of 0-1, adequate organ and bone marrow function, and a life expectancy of at least 3 months. Patients must have received complete COVID-19 vaccination and meet specific requirements regarding previous treatments.

Main exclusion criteria: Patients with active or untreated brain metastases, autoimmune diseases, organ transplants requiring immunosuppression, active infections, pregnancy or breastfeeding, and those taking immunosuppressive medications are excluded.

Trial focus: The study evaluates the safety and effectiveness of BT-001 both alone and combined with pembrolizumab. BT-001 is injected directly into tumors to kill cancer cells and stimulate immune response. Pembrolizumab is given as an IV infusion to enhance immune system activity against cancer. The trial monitors tumor response, safety, and duration of treatment effects.

Investigational drugs: BT-001 is an oncolytic virus therapy injected directly into tumors to destroy cancer cells while stimulating immune response. Pembrolizumab is an established immunotherapy given by IV infusion that helps the immune system recognize and attack cancer cells by blocking the PD-1 protein.

Study of IMC-F106C alone and with checkpoint inhibitors in patients with advanced PRAME-positive cancers who have HLA-A*02:01

This trial studies IMC-F106C (brenetafusp), a bispecific molecule targeting PRAME-positive cancers, including melanoma, in patients with the HLA-A*02:01 genetic marker. The treatment is tested alone and in combination with checkpoint inhibitors.

Main inclusion criteria: Patients must be 18 years or older with HLA-A*02:01-positive status and PRAME-positive tumors. They must have measurable disease, an ECOG performance status of 0 or 1, a life expectancy of at least 12 weeks, and adequate organ and bone marrow function. Patients must provide tumor tissue samples and be willing to follow study procedures.

Main exclusion criteria: Patients with prior PRAME-targeted therapy, active or untreated brain metastases, severe allergic reactions to antibody treatments, uncontrolled heart disease, active infections, HIV/Hepatitis B/Hepatitis C infection, pregnancy or breastfeeding, and other active cancers requiring treatment are excluded.

Trial focus: The study evaluates the safety, tolerability, and optimal dosing of IMC-F106C when used alone and with checkpoint inhibitors. The drug is designed to help the immune system recognize and attack PRAME-positive cancer cells. Participants receive treatment through IV and SC injections with regular monitoring for side effects and tumor response.

Investigational drugs: IMC-F106C is an investigational immunotherapy administered through IV and SC injection. It targets PRAME proteins on cancer cells, helping the immune system recognize and attack them. The medication is being evaluated in Phase 1/2 trials as both monotherapy and in combination with checkpoint inhibitors.

Study of IPN01194 for Adults with Advanced Solid Tumors, Including Melanoma, Head and Neck Cancer, Pancreatic Cancer, and Colorectal Cancer

This study tests IPN01194, an ERK1/2 inhibitor, in patients with advanced solid tumors including melanoma. The trial is divided into two phases: Phase 1 determines the safest effective dose, and Phase 2 evaluates how well the treatment works.

Main inclusion criteria: Participants must be at least 18 years old with confirmed metastatic solid tumor diagnosis, including melanoma. They must have measurable disease according to RECIST 1.1, an ECOG performance status of 0 or 1, and tumors with specific MAPK mutations. Patients must provide tumor tissue samples and agree to use contraception.

Main exclusion criteria: Patients with different cancer types than specified, those outside the age range, members of vulnerable populations, those with interfering medical conditions or medications, pregnant or breastfeeding women, and recent clinical trial participants are excluded.

Trial focus: The study evaluates IPN01194’s safety and effectiveness in reducing tumor size in patients with advanced melanoma and other solid tumors. Participants receive the medication orally in capsule form. Regular assessments monitor tumor response, side effects, and overall health through check-ups, blood tests, and imaging studies.

Investigational drugs: IPN01194 is an oral medication in early-phase research (Phase I/II) that works by inhibiting ERK1/2 proteins involved in cancer cell growth. It is being studied for various advanced solid tumors including melanoma with specific genetic mutations.

Study of mRNA-4157 and Pembrolizumab for Patients with Metastatic Melanoma

This Phase 2 trial compares V940 (mRNA-4157), an mRNA-based cancer vaccine, combined with pembrolizumab immunotherapy versus pembrolizumab with placebo in patients with newly diagnosed metastatic melanoma.

Main inclusion criteria: Patients must be at least 18 years old with unresectable Stage III or IV melanoma confirmed by tissue examination. They must not have received prior treatment for metastatic disease except in specific circumstances. Patients need documented BRAF mutation status, at least one measurable tumor, adequate organ function, and an ECOG performance status of 0-1. They must provide tumor tissue samples and use effective contraception if applicable.

Main exclusion criteria: Patients with prior immunotherapy for melanoma, active autoimmune disease requiring treatment, other recent cancers, active brain metastases, recent live vaccines, pregnancy or breastfeeding, active infections, history of pneumonitis, severe heart disease, or other serious medical conditions are excluded.

Trial focus: The study evaluates whether adding V940 to pembrolizumab improves progression-free survival compared to pembrolizumab alone. V940 is created from the patient’s tumor tissue to help the immune system target specific cancer cells. Participants receive treatment through IV infusion and SC injection with regular monitoring through imaging and blood tests.

Investigational drugs: V940 (mRNA-4157) is an investigational mRNA cancer vaccine administered by injection that encodes for neoantigens specific to the patient’s tumor. Pembrolizumab is an FDA-approved immunotherapy given by IV infusion that blocks the PD-1 pathway to help the immune system attack cancer cells.

Study of Pembrolizumab for Children with Advanced Melanoma or PD-L1 Positive Solid Tumors and Lymphoma

This trial studies pembrolizumab (Keytruda) immunotherapy in children with advanced melanoma or other solid tumors and lymphomas that have returned or not responded to treatment.

Main inclusion criteria: Participants must be between 6 months and less than 18 years old with advanced, relapsed, or refractory cancer confirmed by tissue examination. They must have at least one measurable tumor according to RECIST 1.1 criteria, a performance status of 50 or higher (Lansky or Karnofsky scale), adequate organ function, and recovered from previous treatment side effects. Adolescents who have entered puberty must agree to use contraception.

Main exclusion criteria: Patients with different cancer types than specified, those with specific genetic features (MSI-H or dMMR in certain conditions), inability to tolerate treatment, other interfering medical conditions, inability to provide informed consent, or inability to follow study procedures are excluded.

Trial focus: The study evaluates pembrolizumab’s safety, tolerability, and effectiveness in children with advanced melanoma and other cancers. Participants receive the medication through IV infusion with regular monitoring for side effects and tumor response. The trial measures antitumor activity, progression-free survival, and overall survival.

Investigational drugs: Pembrolizumab is an immunotherapy medication given by IV infusion that blocks the PD-1 protein on immune cells, enhancing the body’s immune response against cancer cells. It is classified as an immune checkpoint inhibitor.

Study of Vemurafenib, Cobimetinib, and Atezolizumab for Patients with High-Risk, Surgically Removable BRAF Mutated and Wild-Type Melanoma

This study tests a combination of three medications for high-risk melanoma that can be surgically removed. Patients receive vemurafenib and cobimetinib (oral tablets) followed by atezolizumab (IV injection) before and after surgery.

Main inclusion criteria: Patients must be at least 18 years old with confirmed Stage IIIB, IIIC, or IIID resectable melanoma. The melanoma must be surgically removable without involving major blood vessels, nerves, or bones. Women of childbearing potential and men must use reliable contraception during and after treatment. Patients must have adequate organ function and recovered from previous treatment side effects.

Main exclusion criteria: Patients with non-high-risk melanoma, unsuitable BRAF mutations, incorrect age range, or members of vulnerable populations are excluded.

Trial focus: The study evaluates whether this three-drug combination can effectively shrink tumors before surgery and prevent cancer recurrence. Vemurafenib targets mutated BRAF protein, cobimetinib blocks the MEK protein pathway, and atezolizumab helps the immune system fight cancer. Patients undergo regular monitoring with imaging, blood tests, and follow-up visits.

Investigational drugs: Vemurafenib (oral tablet) is a BRAF inhibitor that blocks the BRAF protein involved in cancer cell growth. Cobimetinib (oral tablet) is a MEK inhibitor that blocks another protein in the cell growth pathway. Atezolizumab (IV infusion) is an immune checkpoint inhibitor that blocks PD-L1, allowing immune cells to attack cancer cells.

Study on [68Ga]Ga-FAPI-46 and Fludeoxyglucose (18F) PET/CT Imaging for Evaluating Treatment Response in Patients with Advanced Malignant Melanoma

This trial uses [68Ga]Ga-FAPI-46 PET/CT imaging, a specialized scanning technique, to evaluate how well patients with advanced melanoma respond to immune checkpoint inhibitor therapy.

Main inclusion criteria: Patients must be over 18 years old with confirmed metastatic or locally advanced melanoma that is inoperable. They must have visible cancer on imaging scans, be medically suitable for immune checkpoint inhibitor therapy (pembrolizumab or ipilimumab+nivolumab), and be able to read and understand the patient information in Danish to give informed consent.

Main exclusion criteria: Patients without advanced stage melanoma, those not receiving immune checkpoint inhibitor therapy, those outside the age range, and those unable to give consent are excluded.

Trial focus: The study compares [68Ga]Ga-FAPI-46 PET/CT imaging with standard [18F]FDG imaging to evaluate treatment response. The new imaging method may detect changes in cancerous lesions more effectively. Researchers monitor how the tracer uptake in tumors relates to clinical response and potential side effects. Blood samples are analyzed to identify biomarkers that predict treatment outcomes.

Investigational drugs: [68Ga]Ga-FAPI-46 is a radiopharmaceutical imaging agent given by injection that binds to fibroblast activation protein in cancer tissues, enabling detailed PET/CT imaging of melanoma response to treatment.

Study on Early Detection of Side Effects in Metastatic Melanoma Patients Using Zirconium (89Zr) Crefmirlimab Berdoxam Imaging

This study uses [89Zr]Zr-Df-IAB22M2C PET imaging to detect potential side effects early in patients with metastatic melanoma receiving immune checkpoint inhibitor therapy.

Main inclusion criteria: Patients must be 18 years or older with metastatic or irresectable melanoma confirmed by biopsy, scheduled for immune checkpoint therapy, and have an ECOG Status of 2 or less. They must be able to understand and sign informed consent, follow the study schedule, and agree to use double-barrier contraception until 28 days after the last study injection.

Main exclusion criteria: Patients without melanoma diagnosis, those outside the age range, those not in the clinical trial group, and vulnerable populations are excluded.

Trial focus: The study evaluates whether PET imaging with [89Zr]Zr-Df-IAB22M2C can detect immune-related side effects before and after immune checkpoint inhibitor therapy. The imaging agent helps visualize CD8+ T-cells (immune cells) in the body. Participants receive an IV injection of the imaging agent with regular PET scans and health monitoring.

Investigational drugs: [89Zr]Zr-Df-IAB22M2C is a radiopharmaceutical imaging agent administered by IV that binds to CD8+ T-cells, allowing visualization through PET scans to detect immune-mediated side effects early in melanoma patients undergoing immunotherapy.

Study on Encorafenib, Binimetinib, Cemiplimab, and Fianlimab for Patients with BRAF-Mutated Melanoma and Brain Metastases

This trial tests a four-drug combination for patients with BRAF-mutated melanoma that has spread to the brain causing symptoms. Participants receive encorafenib and binimetinib (oral tablets) followed by cemiplimab and fianlimab (IV infusions).

Main inclusion criteria: Patients must have symptomatic brain metastases from BRAF V600-mutated melanoma, adequate liver and kidney function, known BRAF V600 mutation status, and an ECOG performance status of 0-2. Previous immunotherapy is allowed if severe side effects have resolved. Female patients must have a negative pregnancy test and agree to use contraception for 6 months after treatment. Male patients must also use contraception for 6 months.

Main exclusion criteria: Patients without BRAF V600 mutation, those without symptomatic brain metastases, and those outside the specified criteria are excluded.

Trial focus: The study evaluates whether this four-drug combination improves progression-free survival in patients with BRAF-mutated melanoma and brain metastases. Encorafenib blocks BRAF protein, binimetinib blocks MEK protein, cemiplimab blocks PD-1, and fianlimab targets another immune checkpoint. Treatment continues with regular monitoring for up to 24 months.

Investigational drugs: Encorafenib (oral) is a BRAF inhibitor. Binimetinib (oral) is a MEK inhibitor. Cemiplimab (IV) is a PD-1 checkpoint inhibitor. Fianlimab (IV) is an experimental checkpoint inhibitor. All work together to block cancer cell growth and enhance immune response.

Summary

This overview presents 71 ongoing clinical trials for malignant melanoma across Europe and beyond. The trials span multiple countries, with significant activity in Germany, France, Italy, Spain, Belgium, and the Netherlands. Several trials are also being conducted in the United States and other regions.

The research covers various treatment approaches including immunotherapies (pembrolizumab, nivolumab, ipilimumab), targeted therapies for BRAF-mutated melanoma (encorafenib, binimetinib), cell therapies (CAR-T, TIL therapy), and novel agents like bispecific molecules and mRNA vaccines. Many trials test combination approaches to improve treatment outcomes.

The studies address different stages of melanoma, from high-risk resectable disease to advanced metastatic melanoma. Several trials focus on specific patient populations such as those with brain metastases, BRAF mutations, or PD-1 refractory disease. Notable innovations include personalized cell therapies, imaging studies to predict treatment response, and strategies to optimize treatment duration and dosing.

These trials represent significant efforts to improve outcomes for melanoma patients through diverse therapeutic strategies and careful evaluation of safety and effectiveness across different disease stages and patient populations.

Ongoing Clinical Trials on Malignant melanoma

  • Study of Heart and Blood Vessel Side Effects in Cancer Patients Receiving Immune Checkpoint Inhibitor Drug Combination Treatment

    Recruiting

    1 1 1 1
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    Hungary

  • Vusolimogene Oderparepvec with Nivolumab for Advanced Melanoma Patients Whose Cancer Progressed After Previous Immunotherapy Treatments

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Greece Italy Poland Spain

  • Study on the Use of Indocyanine Green and Technetium (99mTc) Nanocolloid for Sentinel Node Biopsy in Patients with Melanoma, Oral Cancer, or Penile Cancer

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

  • Study on [68Ga]Ga-FAPI-46 and Fludeoxyglucose (18F) PET/CT Imaging for Evaluating Treatment Response in Patients with Advanced Malignant Melanoma

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark

  • Study of MC2 TCR T Cell Therapy and Epigenetic Drug Treatment for Patients with Advanced Melanoma or Head and Neck Cancer

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

  • Study on PET Imaging with Fianlimab and Cemiplimab for Patients with Advanced Solid Tumors, with or without Platinum-Based Chemotherapy

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

  • Study of Vemurafenib, Cobimetinib, and Atezolizumab for Patients with High-Risk, Surgically Removable BRAF Mutated and Wild-Type Melanoma

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Italy

  • Study on the Effect of Nivolumab and Melphalan in Patients with In-Transit Melanoma Metastases

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands Sweden

  • Study on Early Detection of Side Effects in Metastatic Melanoma Patients Using Zirconium (89Zr) Crefmirlimab Berdoxam Imaging

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Germany

  • Study on Reducing Bleomycin Dose in Electrochemotherapy for Patients with Skin Cancer

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark

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