Clinical trial locations
- Austria
- Belgium
- Bulgaria
- Czechia
- Denmark
- Espagne
- Finland
- France
- Germany
- Greece
- Hungary
- Italy
- Latvia
- Netherlands
- Norway
- Poland
- Romania
- Slovakia
- Spain
- Long-Term Safety Study of Dabrafenib Mesylate and Trametinib Dimethyl Sulfoxide for Patients Benefiting from Previous Treatment in Multiple Indications
- Study Comparing Subcutaneous and Intravenous Nivolumab and Relatlimab for Patients with Untreated Metastatic or Unresectable Melanoma
- Study of Tebentafusp and Pembrolizumab for Patients with Previously Treated Advanced Melanoma
- Study on the Effectiveness of Enfortumab Vedotin and Pembrolizumab for Patients with Advanced Melanoma
- Study Comparing Relatlimab and Nivolumab Combination vs. Nivolumab Alone for Patients with Advanced Melanoma
- Study of BI-1607, Ipilimumab, and Pembrolizumab for Patients with Advanced Melanoma
- Study of Encorafenib, Binimetinib, and Pembrolizumab for Patients with Advanced Melanoma with BRAF V600E/K Mutation
- Study of Encorafenib, Binimetinib, and Pembrolizumab for Patients with BRAF V600E/K Mutation-Positive Melanoma After Anti-PD-1 Therapy
- Study of Subcutaneous Nivolumab with or without Recombinant Human Hyaluronidase PH20 for Patients with Lung, Kidney, Melanoma, Liver, Colorectal, or Bladder Cancer
- Study of Tucidinostat and Nivolumab for Patients with Advanced Melanoma Not Treated with PD-1 or PD-L1 Inhibitors
- Sweden
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 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 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 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.
France
