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Clinical Trials for Metastatic Malignant Melanoma

This article provides information about 29 ongoing clinical trials for metastatic malignant melanoma, a serious form of skin cancer that has spread beyond its original location. These trials are testing various treatment approaches including immunotherapy combinations, targeted therapies, and personalized treatments across multiple European countries and beyond.

Clinical trial locations

Long-Term Safety Study of Dabrafenib Mesylate and Trametinib Dimethyl Sulfoxide for Patients Benefiting from Previous Treatment in Multiple Indications

This trial is designed for patients with various types of cancer who are already receiving treatment with dabrafenib and/or trametinib and continue to benefit from these medications. The study focuses on evaluating the long-term safety of these treatments.

Inclusion criteria: Patients must be currently receiving treatment with dabrafenib and/or trametinib as part of a previous Novartis or GSK-sponsored study where the main study goals have been met. They must be willing and able to attend scheduled visits and follow treatment plans. Written informed consent is required before joining.

Exclusion criteria: The study excludes patients who are not within the specified age range, have unsuitable medical conditions, belong to vulnerable populations, have experienced certain serious side effects, cannot follow study procedures, are currently in another trial, have interfering medical history, or are pregnant or breastfeeding.

Main focus: The primary objective is to assess the long-term safety profile of dabrafenib and trametinib, monitoring for adverse events and serious adverse events. Regular check-ups will evaluate patient health and treatment effectiveness.

Investigational drugs: Tafinlar (dabrafenib) targets and blocks specific proteins in cancer cells to slow or stop cancer growth. Mekinist (trametinib) works alongside Tafinlar by inhibiting different proteins involved in cancer cell growth and spread, aiming to improve treatment effectiveness.

Study Comparing Subcutaneous and Intravenous Nivolumab and Relatlimab for Patients with Untreated Metastatic or Unresectable Melanoma

This trial compares two methods of administering nivolumab and relatlimab: subcutaneous injection under the skin versus intravenous infusion into a vein. The study aims to determine if the amount of medication in the body is similar between both methods.

Inclusion criteria: Patients must be 12 years or older with confirmed Stage III or IV melanoma. They should have an ECOG performance status of 0 or 1, not have received prior systemic anticancer therapy except for certain previous treatments, and have measurable disease according to RECIST v1.1 criteria.

Exclusion criteria: Patients who have already received treatment, have surgically removable melanoma, have certain medical conditions, are pregnant or breastfeeding, cannot give informed consent, or are participating in another trial cannot join.

Main focus: The primary goal is to evaluate if subcutaneous administration produces comparable medication levels to intravenous administration. The study will also assess cancer response to treatment, including tumor size reduction.

Investigational drugs: Nivolumab is an immune checkpoint inhibitor that helps the immune system recognize and attack cancer cells. Relatlimab enhances immune response by targeting a different pathway, working alongside nivolumab to improve treatment effectiveness.

Study of Tebentafusp and Pembrolizumab for Patients with Previously Treated Advanced Melanoma

This trial examines tebentafusp alone and in combination with pembrolizumab for patients with advanced melanoma who have received previous treatment. The study evaluates whether this combination can improve outcomes compared to other doctor-selected treatments.

Inclusion criteria: Patients must be 18 years or older with HLA-A*02:01-positive status and have unresectable Stage III or Stage IV non-ocular melanoma. They need measurable or non-measurable disease, an ECOG performance status of 0 or 1, and must provide tumor tissue samples.

Exclusion criteria: Patients who have received previous treatment for advanced melanoma outside the eye, are not within the age range, or belong to vulnerable populations cannot participate.

Main focus: The primary objective is to reduce cancer-related DNA in the blood and improve survival rates compared to investigator’s choice treatments. Regular monitoring will assess disease response and safety.

Investigational drugs: Tebentafusp is designed to help the immune system recognize and attack cancer cells in patients with the HLA-A*02:01 genetic marker. Pembrolizumab enhances immune response by blocking proteins that prevent the immune system from attacking cancer.

Study on Adding Diclofenac to PD-1 Inhibitor Therapy for Patients with Metastatic Melanoma

This trial tests whether adding diclofenac to ongoing PD-1 inhibitor therapy can improve outcomes for patients whose cancer has stabilized but not significantly improved.

Inclusion criteria: Patients must have metastatic melanoma that cannot be surgically removed and be receiving anti-PD-1 therapy with stable disease as their best response. They should have a BRAF-V600 mutation with prior targeted therapy if applicable, adequate tumor tissue for biopsy, ECOG performance status of 0 or 1, and sufficient organ function.

Exclusion criteria: Patients with different cancer types, those not receiving PD-1 inhibitors, those who haven’t achieved stable disease, those outside the age range, or vulnerable populations cannot participate.

Main focus: The study aims to determine if adding diclofenac can convert stable disease to partial or complete response by week 9, as measured by PET-CT imaging using RECIST 1.1 criteria.

Investigational drugs: Diclofenac is an anti-inflammatory medication being tested to see if it enhances PD-1 inhibitor effectiveness. PD-1 Inhibitor Therapy helps the immune system attack cancer cells by blocking proteins that suppress immune response.

Study on Detecting Untreated Brain Metastases in Lung, Breast, and Melanoma Cancer Patients Using Fluorodopa (18F)

This trial evaluates PET-DOPA imaging using fluorodopa (18F) to detect newly diagnosed brain metastases from non-small cell lung cancer, breast cancer, and melanoma that are at least 5 mm in size.

Inclusion criteria: Patients must have confirmed primary cancer diagnosis and brain metastases larger than 5 mm visible on MRI. They must be 18 years or older.

Exclusion criteria: Patients with brain metastases larger than 5 mm as seen on MRI scans.

Main focus: The primary objective is to define PET-DOPA sensitivity in detecting brain metastases compared to MRI, characterizing lesions based on metabolic activity measurements.

Investigational drugs: PET-DOPA is a special imaging agent that highlights brain areas with cancerous growths on PET scans, helping doctors detect new untreated metastases at least 5 mm in size.

Study on the Effectiveness of Enfortumab Vedotin and Pembrolizumab for Patients with Advanced Melanoma

This trial tests the combination of enfortumab vedotin and pembrolizumab for advanced melanoma patients who have already received other treatments. Both medications are administered through intravenous infusion.

Inclusion criteria: Patients must be at least 18 years old with confirmed unresectable or metastatic melanoma, adequate organ function, measurable disease, and must have recovered from previous treatment side effects. They need tumor tissue available for PD-L1 testing.

Exclusion criteria: Patients with other cancer types, age under 18 or over 65, or belonging to vulnerable populations cannot participate.

Main focus: The study evaluates the objective response rate, progression-free survival, overall survival, and clinical benefit rate. It monitors safety by tracking adverse events throughout the 24-month study period.

Investigational drugs: Enfortumab Vedotin is an antibody-drug conjugate that targets and kills cancer cells. Pembrolizumab is an immunotherapy drug that enhances immune response by helping the immune system recognize and attack cancer cells.

Study Comparing Relatlimab and Nivolumab Combination vs. Nivolumab Alone for Patients with Advanced Melanoma

This double-blind trial compares the combination of relatlimab and nivolumab versus nivolumab alone for patients with previously untreated Stage III unresectable or Stage IV melanoma.

Inclusion criteria: Patients must have confirmed Stage III or IV melanoma without prior systemic anticancer therapy. They need tumor tissue from an unresectable or metastatic site for biomarker analyses.

Exclusion criteria: Patients who have received prior treatment, have surgically removable melanoma, have serious health conditions, are pregnant or breastfeeding, cannot follow procedures, have recent cancer history, certain infections, organ transplants, or allergies to study drugs cannot participate.

Main focus: The primary objective is to assess progression-free survival through Blinded Independent Central Review, comparing how long the disease doesn’t worsen between treatment groups.

Investigational drugs: Relatlimab is being tested in combination with nivolumab to see if it slows disease progression in untreated patients. Nivolumab helps the immune system recognize and attack cancer cells by blocking proteins that prevent immune response.

Study of TIL therapy combined with peginterferon alfa-2a and nivolumab for patients with metastatic melanoma

This study evaluates a combination treatment using TIL cells (tumor-infiltrating lymphocytes), peginterferon alfa-2a, and nivolumab for metastatic melanoma patients. The research focuses on safety and tolerability.

Inclusion criteria: Patients must be at least 18 years old with metastatic melanoma that has progressed despite previous treatments. They must have stopped immunotherapy at least 4 weeks and BRAF/MEK inhibitors at least 2 weeks before starting. Brain metastases patients must be stable for 2 months without dexamethasone. Good organ and bone marrow function is required.

Exclusion criteria: Age under 18 or over 75, autoimmune diseases, active brain metastases, active infections (HIV, hepatitis B or C), severe heart conditions, uncontrolled blood pressure, pregnancy, breastfeeding, organ transplant recipients, current participation in other trials, severe kidney or liver problems, recent cancer history, mental conditions affecting compliance, medication allergies, immunosuppressive drug use, or life expectancy less than 3 months.

Main focus: The study assesses safety and tolerability of the combination treatment, monitoring disease response through regular check-ups, imaging studies, and quality of life assessments until December 2027.

Investigational drugs: TIL (Tumor Infiltrating Lymphocytes) are immune cells extracted from tumors, grown in a laboratory, and reintroduced to fight cancer. Nivolumab blocks proteins preventing immune system cancer cell attacks. PEG-IFNa (Pegylated Interferon alpha) is a modified protein that boosts immune system cancer-fighting ability with longer activity duration.

Study of BI-1607, Ipilimumab, and Pembrolizumab for Patients with Advanced Melanoma

This Phase 1b/2a trial tests BI-1607 in combination with ipilimumab and pembrolizumab for unresectable or metastatic melanoma. The study determines recommended doses and assesses treatment effectiveness.

Inclusion criteria: Patients must be 18 or older with confirmed advanced melanoma and disease progression. They need at least one measurable lesion, ECOG performance status 0 or 1, life expectancy of at least 12 weeks, and adequate organ function. A tumor biopsy is required unless a recent sample is available.

Exclusion criteria: Patients with other cancer types, outside the age range, belonging to vulnerable populations, unable to receive combination therapy, or unable to give informed consent cannot participate.

Main focus: Phase 1b determines appropriate medication doses while assessing safety and tolerability. Phase 2a evaluates anti-tumor activity through regular monitoring of tumor response and progression.

Investigational drugs: BI-1607 is an experimental monoclonal antibody targeting specific immune cell proteins to enhance cancer-fighting ability. Ipilimumab blocks proteins that suppress immune response, boosting cancer cell attack. Pembrolizumab blocks proteins on cancer cells, helping immune system detection and attack.

Study of Encorafenib, Binimetinib, and Pembrolizumab for Patients with Advanced Melanoma with BRAF V600E/K Mutation

This trial compares the combination of encorafenib, binimetinib, and pembrolizumab against placebo with pembrolizumab for previously untreated BRAF V600E/K mutation-positive melanoma.

Inclusion criteria: Patients must be 18 or older with confirmed diagnosis and BRAF V600E/K mutation. They need adequate tumor tissue for testing, at least one measurable lesion, life expectancy of at least 12 weeks, ECOG performance status 0 or 1, and adequate organ and heart function.

Exclusion criteria: Patients with other cancer types, outside the age range, not safely able to receive medications, pregnant, breastfeeding, recently in another trial, with interfering medical conditions, or unable to follow procedures cannot participate.

Main focus: The safety lead-in phase determines recommended doses, while Phase 3 evaluates treatment effectiveness through regular monitoring of tumor response and progression using imaging and assessments.

Investigational drugs: Encorafenib blocks BRAF protein activity promoting cancer cell growth. Binimetinib targets a different protein in the cancer cell pathway, enhancing encorafenib’s effect. Pembrolizumab blocks proteins preventing immune system cancer cell attack, boosting natural defenses.

Study of Encorafenib, Binimetinib, and Pembrolizumab for Patients with BRAF V600E/K Mutation-Positive Melanoma After Anti-PD-1 Therapy

This trial compares the triplet combination of encorafenib, binimetinib, and pembrolizumab versus the combination of nivolumab and ipilimumab for patients whose melanoma has progressed after anti-PD-1 therapy.

Inclusion criteria: Patients must be 18 or older with confirmed BRAF V600E/K mutation-positive metastatic or unresectable melanoma. They must have received only one previous treatment line and show resistance to anti-PD-1 therapy. At least one measurable tumor is required, along with ECOG performance status 0 or 1, adequate organ and heart function, and tumor tissue availability for testing.

Exclusion criteria: Patients with other cancer types, outside the age range, or belonging to vulnerable populations cannot participate.

Main focus: The primary goal is to measure overall response rate at week 14, comparing the proportion of patients with significant tumor size reduction between treatment groups. Secondary evaluations include progression-free survival, overall survival, and duration of response.

Investigational drugs: Encorafenib and binimetinib target specific proteins in cancer cells to slow growth. Pembrolizumab, nivolumab, and ipilimumab are immunotherapy drugs that help the immune system fight cancer by activating different immune pathways.

Summary

The 29 clinical trials for metastatic malignant melanoma demonstrate a diverse range of treatment approaches being tested across multiple European countries. A significant concentration of trials is taking place in Germany, France, Spain, and Italy, with many studies also recruiting in Belgium, Poland, and the Netherlands.

Several key treatment strategies emerge from these trials. Immunotherapy combinations are heavily featured, with multiple studies testing pembrolizumab, nivolumab, and ipilimumab in various combinations. Targeted therapies for BRAF V600 mutations are also prominent, particularly combinations of encorafenib and binimetinib with immunotherapy. Novel approaches include TIL (tumor-infiltrating lymphocyte) therapy, personalized treatments, and experimental medications like tebentafusp, botensilimab, and various investigational compounds.

Many trials focus on patients who have previously received treatment and whose disease has progressed, while others specifically recruit treatment-naive patients. Several studies address challenging scenarios such as brain metastases or resistance to checkpoint inhibitors. The trials range from early-phase safety studies to large randomized Phase 3 trials comparing different treatment combinations.

The geographic distribution suggests strong research infrastructure and patient access across Western and Central Europe, with some countries like Germany participating in a particularly high number of studies. This broad international collaboration may help ensure diverse patient representation and faster enrollment.

Ongoing Clinical Trials on Metastatic malignant melanoma

  • Study on Detecting Untreated Brain Metastases in Lung, Breast, and Melanoma Cancer Patients Using Fluorodopa (18F)

    Not recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study of INCB099280 for Patients with Advanced Solid Tumors Who Have Not Received Immunotherapy

    Not recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Greece Hungary Romania

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