Ongoing Clinical Trials for Recurrent Melanoma
There are currently 5 ongoing clinical trials investigating new treatment approaches for recurrent melanoma. These studies are testing various combinations of immunotherapy drugs and targeted therapies across multiple European countries, offering opportunities for patients whose cancer has returned or progressed after previous treatment.
Clinical trial locations
- Belgium
- Bulgaria
- Czechia
- Denmark
- Finland
- France
- Germany
- Study of Cobolimab and Dostarlimab for Children and Young Adults with Newly Diagnosed or Relapsed/Refractory Tumors
- 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 Effectiveness and Safety of RO7198457 and Pembrolizumab for Patients with Untreated Advanced Melanoma
- Greece
- Hungary
- Italy
- Study of Cobolimab and Dostarlimab for Children and Young Adults with Newly Diagnosed or Relapsed/Refractory Tumors
- 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
- Poland
- Slovakia
- Spain
- Study of Cobolimab and Dostarlimab for Children and Young Adults with Newly Diagnosed or Relapsed/Refractory Tumors
- 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 Effectiveness and Safety of RO7198457 and Pembrolizumab for Patients with Untreated Advanced Melanoma
- Study on the Safety and Effects of ATL001 and Nivolumab for Adults with Metastatic or Recurrent Melanoma
Study of Cobolimab and Dostarlimab for Children and Young Adults with Newly Diagnosed or Relapsed/Refractory Tumors
This trial is designed to study two immunotherapy medications, cobolimab and dostarlimab, in children and young adults with tumors that have returned after treatment or have not responded to previous therapies. The study includes patients with recurrent melanoma as well as other types of tumors, such as Hodgkin lymphoma.
Main inclusion criteria: Participants must be between 0 and 21 years old, depending on the study cohort. They need to have advanced or metastatic solid tumors that have worsened despite available treatments. At least one measurable tumor must be present, and participants must have adequate organ function based on blood test results. Adolescents who have entered puberty must agree to use contraception, and female participants must not be pregnant or breastfeeding.
Main exclusion criteria: Patients who have not recovered from previous treatments or surgeries, those with uncontrolled serious illnesses, pregnant or breastfeeding patients, and those with a recent history of another cancer are excluded. Patients with organ transplants, active infections requiring treatment, certain heart or lung conditions, or a history of autoimmune diseases or substance abuse are also not eligible.
Focus of the trial: The study aims to understand how safe and tolerable these medications are when used together and to determine the best dose for treatment. It is conducted in two parts: the first assesses safety and dosage in patients with advanced solid tumors, while the second focuses on specific cancer types to evaluate treatment effectiveness.
Investigational drugs: Cobolimab and dostarlimab are both given through intravenous infusion. These immunotherapy agents work by helping the body’s immune system recognize and attack cancer cells more effectively.
Study of Encorafenib, Binimetinib, and Pembrolizumab for Patients with Advanced Melanoma with BRAF V600E/K Mutation
This trial focuses on patients with advanced melanoma that has spread to other parts of the body or cannot be removed by surgery. The study specifically targets patients with a BRAF V600E/K mutation, a genetic change that makes the cancer more aggressive.
Main inclusion criteria: Participants must be at least 18 years old with confirmed metastatic or unresectable melanoma. They must have the BRAF V600E or V600K mutation confirmed by laboratory testing and provide adequate tumor tissue for testing. For the Safety Lead-In phase, patients should not have received more than one previous treatment, while Phase 3 participants should have received no prior treatment for advanced disease. Patients must have at least one measurable tumor and good general health with adequate organ and heart function.
Main exclusion criteria: Patients with other types of cancer, recent treatments for their condition, serious heart or liver/kidney problems, pregnancy or breastfeeding, uncontrolled infections, or other serious illnesses are excluded. Those unable to follow study procedures are also not eligible.
Focus of the trial: The study compares the effectiveness of a three-drug combination of encorafenib, binimetinib, and pembrolizumab against a placebo combined with pembrolizumab. The trial will last up to 24 months and aims to determine if the combination can improve outcomes for patients with this specific type of melanoma.
Investigational drugs: Encorafenib and binimetinib are taken as capsules and tablets, respectively, while pembrolizumab is given through intravenous infusion. Encorafenib and binimetinib target specific proteins in cancer cells to slow their growth, while pembrolizumab helps the immune system recognize and attack cancer cells.
Study of Encorafenib, Binimetinib, and Pembrolizumab for Patients with BRAF V600E/K Mutation-Positive Melanoma After Anti-PD-1 Therapy
This clinical trial is designed for patients with BRAF V600E/K mutation-positive melanoma that has either spread to other parts of the body or cannot be removed surgically. These patients have already received anti-PD-1 therapy, a type of immunotherapy, but their cancer has continued to grow.
Main inclusion criteria: Participants must be at least 18 years old with confirmed metastatic or unresectable melanoma. They must have the BRAF V600E or V600K mutation and provide tumor tissue for laboratory testing. Patients should have received only one previous treatment for advanced disease, which must have been anti-PD-1 monotherapy such as nivolumab or pembrolizumab. The cancer must be resistant to anti-PD-1 treatment, meaning it did not respond or stopped responding. Participants must have at least one measurable tumor and good general health with adequate organ and heart function.
Main exclusion criteria: The trial excludes patients with other types of cancer, those who have received multiple previous treatments, serious medical conditions, pregnancy or breastfeeding, or inability to follow study procedures.
Focus of the trial: The study compares two different treatment combinations: one group receives encorafenib, binimetinib, and pembrolizumab, while the other receives nivolumab and ipilimumab. The goal is to see which combination is more effective in controlling cancer that has not responded to previous immunotherapy.
Investigational drugs: Encorafenib and binimetinib are taken as tablets, while pembrolizumab, nivolumab, and ipilimumab are given through intravenous infusion. These medications work together to target cancer cells and boost the immune system’s ability to fight the disease.
Study on the Effectiveness and Safety of RO7198457 and Pembrolizumab for Patients with Untreated Advanced Melanoma
This trial evaluates the combination of RO7198457, also known as Autogene Cevumeran, and pembrolizumab in patients with advanced melanoma who have not yet received treatment for their condition. RO7198457 uses mRNA technology, while pembrolizumab is an established immunotherapy medication.
Main inclusion criteria: Patients must have advanced melanoma that is either metastatic or cannot be surgically removed. They must have a confirmed diagnosis of either recurrent or newly diagnosed Stage IV, or locally advanced Stage IIIC or IIID melanoma. Participants must be at least 18 years old with a good performance status and a life expectancy of at least 12 weeks. Adequate blood and organ function is required, and patients must have measurable disease. Importantly, patients should not have received prior systemic anti-cancer therapy for advanced disease, except in certain specified cases.
Main exclusion criteria: Patients with other types of cancer, those not within the specified age range, vulnerable populations unable to give consent, those with medical conditions or taking medications that could interfere with treatment, and those with serious health conditions that could affect safety are excluded.
Focus of the trial: The study compares the combination of RO7198457 and pembrolizumab against pembrolizumab alone. The main goal is to measure how long patients live without their cancer worsening, known as progression-free survival. The trial will run for up to 24 months and will closely monitor effectiveness, safety, and quality of life.
Investigational drugs: Both RO7198457 and pembrolizumab are administered through intravenous infusion. RO7198457 stimulates the immune system to recognize and attack cancer cells, while pembrolizumab blocks a specific protein on immune cells, allowing them to better attack cancer cells.
Study on the Safety and Effects of ATL001 and Nivolumab for Adults with Metastatic or Recurrent Melanoma
This trial tests a personalized cell therapy called ATL001, which uses the patient’s own immune cells modified to better recognize and attack cancer cells. The study also involves nivolumab, a medication that helps the immune system fight cancer.
Main inclusion criteria: Patients must be at least 18 years old with metastatic or recurrent melanoma. They must agree to use effective birth control during the study and for specific periods afterward. Participants must have a life expectancy of at least 6 months at the time of tissue collection and measurable disease according to specific criteria. Before receiving ATL001, patients must have received a PD-1/PD-L1 inhibitor and experienced either disease progression or stable disease after at least 4 doses. Patients with BRAF V600 mutation must have received targeted therapy for this mutation. Participants must be medically fit to undergo all study procedures and have adequate organ function based on blood test results.
Main exclusion criteria: Patients with other types of cancer, those outside the specified age range, those unable to give informed consent, pregnant or breastfeeding patients, those with medical conditions that might interfere with the study, those currently in another trial, those with recent major surgery, severe allergic reactions to similar treatments, active infections requiring treatment, or a history of substance abuse are excluded.
Focus of the trial: The study evaluates the safety and effectiveness of ATL001 both alone and in combination with nivolumab. Participants receive these treatments through infusion and are monitored over time to observe side effects, tumor response, and overall survival rates.
Investigational drugs: ATL001 involves using specially modified T cells that target specific mutations in cancer cells. Before receiving ATL001, patients undergo lymphodepletion with fludarabine and cyclophosphamide to prepare the body. Nivolumab is administered intravenously and works by blocking a protein that prevents the immune system from attacking cancer cells.
Summary
The five ongoing clinical trials for recurrent melanoma demonstrate significant focus on combination immunotherapy approaches, particularly involving pembrolizumab and nivolumab. A notable concentration of trials is occurring in Spain and Germany, with Spain hosting all five studies and Germany participating in four. Many trials specifically target patients with the BRAF V600E/K mutation, reflecting the importance of this genetic marker in treatment decisions.
The trials range from studies for children and young adults to adult-focused research, with varying requirements regarding previous treatments. Some trials specifically recruit patients who have not responded to prior anti-PD-1 therapy, while others focus on treatment-naive patients. The combination of targeted therapies with immunotherapy agents represents a key theme across multiple studies, aiming to improve outcomes for patients with this challenging disease. All trials are carefully designed to monitor both effectiveness and safety, with regular assessments throughout the treatment period.
