Superficial spreading melanoma stage IV Trials in Disease

Study on the Safety and Effects of ATL001 and Nivolumab for Adults with Metastatic or Recurrent Melanoma

This trial is testing a new personalized treatment approach for patients whose melanoma has spread to other parts of the body or has returned after previous treatment. The study is being conducted in Spain and will run until July 2027.

Main inclusion criteria:

• Patients must be at least 18 years old
• Confirmed diagnosis of metastatic or recurrent melanoma, meaning the cancer has spread or come back after treatment
• Life expectancy of at least 6 months
• Must have previously received treatment with a PD-1/PD-L1 inhibitor and either experienced disease progression or stable disease after at least 4 doses
• Patients with tumors carrying the BRAF V600 mutation must have previously received targeted therapy for this mutation
• Good overall health status, able to carry out normal activities or have only mild symptoms
• Adequate organ function as shown by blood tests
• Women of childbearing age and sexually active men must use effective birth control during the study and for several months after treatment

Main exclusion criteria:

• Other types of cancer besides metastatic or recurrent melanoma
• Pregnancy or breastfeeding
• Currently participating in another clinical trial
• Recent major surgery or still recovering from surgery
• Active infection requiring treatment
• History of severe allergic reactions to similar treatments
• Certain medical conditions that could interfere with the study or be made worse by the treatment
• Unable to understand the study and provide informed consent

Focus and goals of the trial:

The study aims to evaluate both the safety and effectiveness of a personalized cell therapy called ATL001, used alone and in combination with nivolumab. The trial follows a structured approach that begins with collecting tumor tissue from the patient, which is then used to create the personalized ATL001 treatment. Before receiving ATL001, patients undergo a process called lymphodepletion, where medications are given to temporarily reduce the number of immune cells in the body. This helps prepare the body to better accept and respond to the personalized therapy.

The ATL001 treatment is given through an infusion directly into the bloodstream. In some cases, it is combined with nivolumab, which is also given by infusion. Throughout the study, patients have regular check-ups including physical examinations, imaging tests, and blood tests to monitor how well the treatment is working and to watch for any side effects. The study will look at changes in tumor size and overall survival rates.

Investigational drugs:

ATL001 is a personalized immunotherapy that uses the patient's own immune cells, specifically T cells. These cells are modified to better recognize and attack cancer cells by targeting unique markers called neoantigens found on the surface of cancer cells. This approach is designed to enhance the body's natural immune response against melanoma.

Nivolumab, also known by the brand name OPDIVO, is a type of immunotherapy called a checkpoint inhibitor. It works by blocking a protein called PD-1 that normally prevents the immune system from attacking cancer cells. By blocking this protein, nivolumab helps the immune system recognize and fight cancer more effectively. This medication is already an established treatment for various types of cancer, including melanoma.