Ongoing Clinical Trials for Malignant Melanoma Stage III
There are currently 13 clinical trials investigating new treatments for patients with Stage III malignant melanoma. These studies are testing various immunotherapies, targeted therapies, and combination treatments across multiple countries in Europe. The trials focus on preventing cancer recurrence after surgery, treating advanced disease, and improving patient outcomes through innovative approaches including personalized medicines and novel drug combinations.
Clinical trial locations
- Austria
- Belgium
- Study of Regorafenib with BRAF/MEK-Inhibitor Combination for Patients with Advanced Melanoma After Previous Treatment
- Study of Encorafenib, Binimetinib, and Pembrolizumab for Patients with Advanced Melanoma with BRAF V600E/K Mutation
- Study of Nivolumab and Relatlimab for Patients with Stage III-IV Melanoma After Surgery
- Study on Pembrolizumab for Patients with High-Risk Stage III Melanoma After Surgery
- Bulgaria
- Czechia
- Denmark
- Finland
- France
- Study Comparing Ipilimumab and Nivolumab with Standard Nivolumab for Patients with Stage III Melanoma
- Study on L19IL2 and L19TNF Treatment Before Surgery for Patients with Advanced Melanoma
- Study of Nivolumab and Relatlimab for Patients with Stage III-IV Melanoma After Surgery
- Study on Pembrolizumab for Patients with High-Risk Stage III Melanoma After Surgery
- Germany
- Study of Regorafenib with BRAF/MEK-Inhibitor Combination for Patients with Advanced Melanoma After Previous Treatment
- 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 L19IL2 and L19TNF Treatment Before Surgery for Patients with Advanced Melanoma
- Study of Nivolumab and Relatlimab for Patients with Stage III-IV Melanoma After Surgery
- Study on Pembrolizumab for Patients with High-Risk Stage III Melanoma After Surgery
- Study on the Effectiveness and Safety of RO7198457 and Pembrolizumab for Patients with Untreated Advanced Melanoma
- Greece
- Hungary
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Study of LTX-315 and Pembrolizumab for Patients with Resectable Stage III-IV Melanoma
This trial is testing a combination of two medications for patients whose Stage III or IV melanoma can be surgically removed. The treatment involves LTX-315, injected directly into the tumor, and pembrolizumab (also known as Keytruda), given through an intravenous infusion. This approach is called neoadjuvant therapy, meaning the treatment is given before surgery to help shrink the tumor.
Main inclusion criteria: Participants must be at least 18 years old with Stage III or IV melanoma confirmed by medical specialists. The cancer must be visible and measurable, and patients must be healthy enough for the planned surgery. They need at least one lesion suitable for injection (no larger than 3.0 cm) and must have adequate organ function, including acceptable blood counts, liver, and kidney function.
Main exclusion criteria: Patients with other types of cancer, those who have already received treatment that might affect the study results, people with serious health conditions, pregnant or breastfeeding women, and those unable to follow study procedures are excluded.
Study focus: The trial aims to see if the combination of LTX-315 and pembrolizumab can shrink tumors before surgery, making them easier to remove. The primary measure of success is the rate of complete pathological response, which indicates no remaining cancer cells after treatment and surgery.
Investigational drugs: LTX-315 is an experimental medication designed to disrupt tumor cells and stimulate an immune response. Pembrolizumab is an immune checkpoint inhibitor that blocks the PD-1 protein, helping the immune system recognize and destroy cancer cells.
Study of Regorafenib with BRAF/MEK-Inhibitor Combination for Patients with Advanced Melanoma After Previous Treatment
This trial is evaluating regorafenib when added to BRAF and MEK inhibitor treatment for patients with advanced melanoma who have already received previous therapy. The study specifically focuses on patients with the BRAF V600 mutation whose cancer has continued to grow despite treatment.
Main inclusion criteria: Participants must be at least 18 years old and able to take oral medication. They must have advanced melanoma that is either unresectable or has spread, with confirmed BRAF V600E or V600K mutation. Patients must have measurable tumors and adequate organ and heart function.
Main exclusion criteria: Patients without melanoma, those not treated with BRAF-MEK inhibitors, patients whose cancer has not worsened on these therapies, and vulnerable populations are excluded.
Study focus: The trial evaluates whether adding regorafenib to existing BRAF-MEK inhibitor treatment can better control the disease in patients who have specific genetic mutations and have already been treated with other therapies.
Investigational drugs: Regorafenib is a multikinase inhibitor that blocks multiple proteins involved in tumor growth. It is taken as oral tablets and is being studied for its ability to control advanced melanoma with BRAF V600 mutations.
Study on the Safety of Continued Treatment with GME751 (Pembrolizumab Biosimilar) for Patients with Melanoma or Non-Small Cell Lung Cancer
This study assesses the safety of continuing treatment with GME751, a proposed biosimilar to pembrolizumab, for patients who have previously participated in earlier studies and are eligible to continue therapy. The trial is open to patients with both melanoma and non-small-cell lung cancer.
Main inclusion criteria: Participants must be at least 18 years old and have participated in either Study 101 or Study 301, with their doctor determining they would benefit from continued pembrolizumab treatment. They must have followed the rules of the previous studies.
Main exclusion criteria: Patients with cancer types other than melanoma or non-small-cell lung cancer, those outside the specified age range, and those not part of the specified clinical trial groups cannot participate.
Study focus: The main objective is to assess the safety of continued treatment with GME751 by monitoring serious adverse events for up to 6-12 months for melanoma patients and up to 12-24 months for lung cancer patients.
Investigational drugs: GME751 is a proposed biosimilar to pembrolizumab, an immune checkpoint inhibitor that enhances the immune system’s ability to fight cancer by blocking the PD-1 pathway.
Study Comparing Ipilimumab and Nivolumab to Nivolumab Alone for Patients with Resectable Stage III Melanoma
This trial compares two treatment approaches for Stage III melanoma that can be surgically removed. One group receives a combination of YERVOY (ipilimumab) and OPDIVO (nivolumab), while the other receives OPDIVO alone. Both medications are given through intravenous infusion.
Main inclusion criteria: Participants must be at least 18 years old with Stage III melanoma confirmed by doctors. The cancer must be completely removable by surgery. Patients need a WHO Performance Status of 0 or 1. Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control.
Main exclusion criteria: Patients who have not had their melanoma surgically removed, those unable to receive immune checkpoint inhibitors, patients with serious health conditions, and pregnant or breastfeeding women are excluded.
Study focus: The trial aims to determine how well the combination therapy prevents cancer from returning or worsening compared to single-agent therapy, measuring progression-free survival and overall survival.
Investigational drugs: Nivolumab blocks the PD-1 protein on immune cells, while ipilimumab blocks the CTLA-4 protein. Both help the immune system better recognize and attack cancer cells.
Study Comparing Ipilimumab and Nivolumab with Standard Nivolumab for Patients with Stage III Melanoma
This study compares neoadjuvant treatment (before surgery) with ipilimumab and nivolumab followed by surgery, versus surgery followed by adjuvant nivolumab (after surgery) for Stage III melanoma patients.
Main inclusion criteria: Participants must be at least 16 years old with resectable Stage III melanoma confirmed by doctors. They must have WHO Performance Status of 0 or 1, adequate organ function, and measurable disease. Women of childbearing potential must use reliable birth control and have negative pregnancy tests.
Main exclusion criteria: Patients with other cancers (except successfully treated ones with life expectancy over 5 years), those who received previous immunotherapy targeting CTLA-4, PD-1, or PD-L1, and those who took immunosuppressive medications within 6 months are excluded.
Study focus: The trial compares the effectiveness of giving immunotherapy before surgery versus after surgery in preventing cancer recurrence, measuring recurrence-free survival, local recurrence-free survival, and distant metastasis-free survival.
Investigational drugs: The study uses ipilimumab (anti-CTLA-4), nivolumab (anti-PD-1), and in some cases dabrafenib and trametinib (BRAF and MEK inhibitors) for patients who do not respond to initial treatment.
Study to Evaluate IOpener-Melanoma Test for Predicting Response to Immunotherapy in Stage III or IV Skin Melanoma Patients
This trial evaluates the IOpener-melanoma test, which predicts how patients with unresectable Stage III or Stage IV melanoma will respond to immune checkpoint inhibitors. The test results guide treatment selection between combination therapy and monotherapy.
Main inclusion criteria: Participants must be at least 18 years old with unresectable Stage III or Stage IV cutaneous melanoma. Doctors must be considering immune checkpoint inhibitor treatment. Patients with brain metastases can participate if the metastases are asymptomatic or treated. Life expectancy must be more than 3 months.
Main exclusion criteria: Patients with uveal or mucosal melanoma, those who received prior treatment for advanced melanoma, inability to provide sufficient tumor tissue, serious medical conditions, pregnancy, breastfeeding, and participation in other interventional trials are excluded.
Study focus: The trial aims to determine if the IOpener-melanoma test can accurately predict which patients will benefit from combination immunotherapy versus monotherapy, measuring progression-free survival, overall survival, and quality of life.
Investigational drugs: The study uses various immunotherapy combinations including pembrolizumab (Keytruda), nivolumab (Opdivo), ipilimumab, or PHF00230MIG, based on test results.
Study of Encorafenib, Binimetinib, and Pembrolizumab for Patients with Advanced Melanoma with BRAF V600E/K Mutation
This trial tests a three-drug combination for patients with advanced melanoma that has specific BRAF V600E/K mutations. The study compares treatment with encorafenib, binimetinib, and pembrolizumab against pembrolizumab with placebo.
Main inclusion criteria: Participants must be at least 18 years old with metastatic or unresectable melanoma confirmed by histology. They must have BRAF V600E or V600K mutation confirmed by laboratory testing and provide adequate tumor tissue. Patients must have measurable disease and ECOG Performance Status of 0 or 1.
Main exclusion criteria: Patients with other cancers, recent different cancer treatments, serious heart, liver, or kidney problems, pregnant or breastfeeding women, uncontrolled infections, and those unable to follow study procedures are excluded.
Study focus: The trial evaluates whether the combination of three medications can improve outcomes compared to immunotherapy alone in patients with BRAF-mutated advanced melanoma, measuring tumor response, progression-free survival, and overall survival.
Investigational drugs: Encorafenib is a BRAF inhibitor taken orally, binimetinib is a MEK inhibitor taken orally, and pembrolizumab is an immune checkpoint inhibitor given by infusion. Together they target both the cancer’s growth pathway and enhance immune response.
Study of Encorafenib, Binimetinib, and Pembrolizumab for Patients with BRAF V600E/K Mutation-Positive Melanoma After Anti-PD-1 Therapy
This study is for patients whose BRAF V600E/K mutation-positive melanoma has continued to grow despite treatment with anti-PD-1 therapy. It compares a three-drug combination (encorafenib, binimetinib, and pembrolizumab) with a two-drug combination (nivolumab and ipilimumab).
Main inclusion criteria: Participants must be at least 18 years old with metastatic or unresectable melanoma confirmed by histology and BRAF V600E or V600K mutation. They must have received only one previous treatment and have melanoma resistant to anti-PD-1 treatment. Patients must have measurable disease and ECOG Performance Status of 0 or 1.
Main exclusion criteria: Patients with cancer types other than melanoma, those not previously treated with BRAF-MEK inhibitors, cancer that has not worsened on BRAF-MEK inhibitor therapy, and vulnerable populations are excluded.
Study focus: The trial aims to determine which treatment combination works better for patients whose cancer has progressed after anti-PD-1 therapy, measuring overall response rate, progression-free survival, and overall survival.
Investigational drugs: The study uses encorafenib (BRAF inhibitor), binimetinib (MEK inhibitor), pembrolizumab (anti-PD-1), nivolumab (anti-PD-1), and ipilimumab (anti-CTLA-4), combining targeted therapy and immunotherapy approaches.
Study of Nivolumab and Relatlimab for Patients with Stage III-IV Melanoma After Surgery
This trial compares a combination of nivolumab and relatlimab with nivolumab alone for patients with Stage III-IV melanoma that has been completely removed by surgery. The study aims to prevent cancer recurrence after surgical removal.
Main inclusion criteria: Participants must have Stage IIIA (with tumor larger than 1 mm in lymph node), IIIB, IIIC, IIID, or Stage IV melanoma completely removed by surgery with clear margins. They must have no signs of disease confirmed by physical examination and imaging. Participants must be at least 12 years old (or 18 where local rules require).
Main exclusion criteria: Patients who have not had their Stage III or Stage IV melanoma completely removed by surgery cannot participate.
Study focus: The trial evaluates whether the combination of nivolumab and relatlimab is more effective than nivolumab alone in preventing cancer recurrence, measuring time to recurrence or death, and overall survival.
Investigational drugs: Nivolumab blocks the PD-1 protein on immune cells, while relatlimab targets the LAG-3 protein. Both are immune checkpoint inhibitors that enhance the immune system’s ability to attack cancer cells.
Study on L19IL2 and L19TNF Treatment Before Surgery for Patients with Advanced Melanoma
This trial tests whether giving Fibromun and Darleukin (containing L19IL2 and L19TNF) before surgery improves outcomes compared to surgery alone for patients with locally advanced Stage III B or III C melanoma.
Main inclusion criteria: Participants must be at least 18 years old with Stage III B or III C malignant melanoma of the skin eligible for complete surgical removal. They must have WHO Performance Status of 0 or 1, life expectancy of at least 24 months, and adequate organ function. Patients need at least one injectable melanoma lesion of 10 mm or larger.
Main exclusion criteria: Patients with other cancer types, melanoma that cannot be surgically removed, no injectable skin or subcutaneous lumps, outside the specified age range, or vulnerable populations are excluded.
Study focus: The study aims to determine if neoadjuvant treatment with L19IL2 and L19TNF before surgery significantly improves recurrence-free survival compared to surgery alone, also evaluating safety and biomarker changes.
Investigational drugs: L19IL2 and L19TNF are immunotherapy agents administered by intratumoral injection to stimulate the immune system to attack cancer cells before surgical removal.
Summary
The 13 ongoing clinical trials for Stage III malignant melanoma demonstrate a strong focus on immunotherapy approaches across Europe, with notable concentration in countries like Germany, France, Italy, Spain, Poland, and Belgium. Several studies are investigating combinations of immune checkpoint inhibitors such as nivolumab, pembrolizumab, ipilimumab, and relatlimab, reflecting the medical community’s interest in enhancing immune system response against melanoma.
A significant number of trials specifically target patients with BRAF V600E/K mutations, testing combinations of targeted therapies (encorafenib, binimetinib) with immunotherapy (pembrolizumab). This highlights the importance of personalized medicine approaches based on genetic characteristics of the cancer.
Many studies focus on the neoadjuvant setting, giving treatment before surgery to shrink tumors, as well as adjuvant treatment after surgery to prevent recurrence. The trials explore various treatment sequences and combinations to optimize outcomes for patients with resectable disease.
The geographic distribution shows strong participation from Western and Central European countries, with limited representation from Eastern Europe and Scandinavia. This may reflect differences in healthcare infrastructure, research funding, and clinical trial networks across European regions.
