In short
There are currently 3 ongoing clinical trials investigating treatments for malignant melanoma of eyelid. These studies focus on testing combination therapies involving targeted drugs and immunotherapies, particularly for patients with specific genetic mutations or those who have received previous treatments. Trials are being conducted across multiple European countries.
Clinical trial locations
- Belgium
- Bulgaria
- Czechia
- Finland
- Germany
- Greece
- Hungary
- Italy
- Poland
- Slovakia
- Spain
- 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 on the Safety and Effects of ATL001 and Nivolumab for Adults with Metastatic or Recurrent Melanoma
Study of Encorafenib, Binimetinib, and Pembrolizumab for Patients with Advanced Melanoma with BRAF V600E/K Mutation
This clinical trial is testing a combination treatment for patients with advanced melanoma that has either spread to other parts of the body or cannot be removed by surgery. The study specifically targets patients whose cancer cells have a genetic change known as the BRAF V600E/K mutation.
Main inclusion criteria: Participants must be at least 18 years old and have confirmed melanoma with the BRAF V600E or V600K mutation. For the main phase of the study, patients should not have received any previous treatment for their advanced melanoma. Participants must have at least one tumor that can be measured and be in good general health with an ECOG Performance Status of 0 or 1. Adequate organ function and heart health are also required, with a heart test showing a Left Ventricular Ejection Fraction of 50% or higher.
Main exclusion criteria: Patients with other types of cancer not related to the study, those who have had recent treatments for cancer, individuals with serious heart, liver, or kidney problems, pregnant or breastfeeding women, and those with uncontrolled infections are excluded. Patients unable to follow the study procedures are also not eligible.
Focus and goal: The trial compares the effectiveness of the three-drug combination of encorafenib, binimetinib, and pembrolizumab against a placebo combined with pembrolizumab. The study aims to determine if this triple therapy can improve outcomes for patients with this specific type of melanoma. The trial will last up to 24 months and will closely monitor participants for safety and treatment response.
Investigational drugs: Encorafenib is taken as a capsule and works by blocking a protein that promotes cancer cell growth. Binimetinib is taken as a tablet and targets a different protein in the cancer growth pathway, enhancing the effect of encorafenib. Pembrolizumab is an immunotherapy drug given through an infusion that helps the immune system recognize and attack cancer cells by blocking a protein that prevents immune response.
Study of Encorafenib, Binimetinib, and Pembrolizumab for Patients with BRAF V600E/K Mutation-Positive Melanoma After Anti-PD-1 Therapy
This trial focuses on patients whose melanoma has continued to grow despite previous treatment with anti-PD-1 therapy, a type of immunotherapy. Like the first study, it targets patients with the BRAF V600E/K mutation.
Main inclusion criteria: Participants must be at least 18 years old with confirmed melanoma that is either not removable by surgery or has spread to other parts of the body. They must have the BRAF V600E or V600K mutation confirmed through testing. Importantly, patients must have received only one previous treatment, which should have been anti-PD-1 monotherapy such as nivolumab or pembrolizumab, and their cancer must have shown resistance to this treatment. Patients must have at least one measurable tumor and be in good general health with an ECOG Performance Status of 0 or 1.
Main exclusion criteria: Similar to the first trial, patients with other types of cancer, those outside the specified age range, pregnant or breastfeeding women, individuals with certain medical conditions that might interfere with the study, those currently in another clinical trial, patients with recent major surgery, history of severe allergic reactions to similar treatments, active infections requiring treatment, or history of substance abuse are excluded.
Focus and goal: The study compares two different treatment combinations. One group receives encorafenib, binimetinib, and pembrolizumab, while the other receives nivolumab and ipilimumab. The trial aims to see which combination is more effective in controlling cancer that has proven resistant to previous immunotherapy. The study will measure overall response rate, progression-free survival, and overall survival.
Investigational drugs: In addition to encorafenib, binimetinib, and pembrolizumab described above, this trial also uses nivolumab and ipilimumab. Both are immunotherapy medications given through intravenous infusion. Nivolumab helps the immune system fight cancer by inhibiting the PD-1 protein on immune cells, while ipilimumab works by targeting the CTLA-4 protein on T-cells, both enhancing the body's natural defense against cancer.
Study on the Safety and Effects of ATL001 and Nivolumab for Adults with Metastatic or Recurrent Melanoma
This trial represents a different approach to treating advanced melanoma, using a personalized cell therapy combined with immunotherapy.
Main inclusion criteria: Patients must be at least 18 years old with confirmed metastatic or recurrent melanoma and a life expectancy of at least 6 months. They must have received previous treatment with a PD-1/PD-L1 inhibitor and experienced either disease progression or stable disease after at least 4 doses. Patients with the BRAF V600 mutation must have received targeted therapy for this mutation as well. Participants must be medically fit to undergo all study procedures, including tissue collection, and have a performance status of 0-1. Adequate organ function shown through blood tests is required. Both male and female patients must agree to use effective birth control methods during and after the study.
Main exclusion criteria: Patients with other types of cancer besides metastatic or recurrent melanoma, those unable to give informed consent, pregnant or breastfeeding women, individuals with certain medical conditions that might interfere with the study or be worsened by treatment, those currently in another clinical trial, patients with recent major surgery, history of severe allergic reactions to similar treatments, active infections requiring treatment, or history of substance abuse are not eligible.
Focus and goal: The study evaluates the safety and effectiveness of ATL001, a personalized therapy using the patient's own modified immune cells, both alone and in combination with nivolumab. The trial involves collecting tissue from the patient's tumor to manufacture the personalized treatment. Before receiving ATL001, patients undergo a process called lymphodepletion to reduce the number of immune cells in the body, making room for the modified cells to work more effectively.
Investigational drugs: ATL001 is a personalized cell therapy using T cells designed to recognize and attack cancer cells. These T cells are modified to target specific markers found on the patient's own cancer cells. The therapy is given as an infusion. Nivolumab, used in combination with ATL001, works by blocking the PD-1 protein on immune cells, enhancing the immune response against cancer.
Summary
Three ongoing clinical trials are investigating treatments for malignant melanoma of the eyelid across multiple European countries. Two of the trials focus on combination therapies using encorafenib, binimetinib, and pembrolizumab, specifically targeting patients with the BRAF V600E/K mutation. These trials differ in their patient populations, with one accepting treatment-naive patients and another focusing on those who have received prior anti-PD-1 therapy.
Germany, Italy, Poland, Slovakia, and Spain are conducting multiple trials, offering more options for patients in these countries. The third trial, conducted only in Spain, explores a novel personalized cell therapy approach using ATL001 combined with nivolumab, representing an innovative direction in treatment.
All three trials emphasize the importance of genetic testing, particularly for BRAF mutations, and target patients with advanced disease. The studies reflect current treatment strategies combining targeted therapies and immunotherapies, as well as exploring new personalized medicine approaches for patients with this challenging disease.
