Desmoplastic melanoma Trials in Disease

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

This clinical trial is being conducted in Spain and focuses on testing a new treatment approach for patients with metastatic or recurrent melanoma, which means the cancer has either spread to other parts of the body or has returned after previous treatment.

Main inclusion criteria:

• Patients must be at least 18 years old
• Must have confirmed metastatic or recurrent melanoma with measurable disease
• Life expectancy of at least 6 months at the time of tissue collection
• Must have previously received treatment with a PD-1/PD-L1 inhibitor medication and experienced either disease progression or stable disease after at least 4 doses
• For patients with a BRAF V600 mutation, must have received targeted therapy for this mutation
• Must have adequate organ function based on blood test results
• Performance status of 0-1, meaning patients are either fully active or have some symptoms but can carry out daily activities without help
• Must be medically fit to undergo tumor tissue collection and receive the required treatments
• Patients of childbearing potential must agree to use effective birth control methods during the study and for several months after treatment

Main exclusion criteria:

• Having other types of cancer besides metastatic or recurrent melanoma
• Being pregnant or breastfeeding
• Currently participating in another clinical trial
• Having had recent major surgery or still recovering from major surgery
• History of severe allergic reactions to similar treatments
• Active infection requiring treatment
• Certain medical conditions that might interfere with the study or be worsened by the treatment
• Unable to give informed consent or understand the study requirements
• History of substance abuse that might interfere with participation

Focus and goal of the trial:

The trial is evaluating the safety and effectiveness of a personalized treatment called ATL001, used both alone and in combination with nivolumab. ATL001 is a form of cell therapy that uses the patient's own immune cells, specifically T cells, which are modified to better recognize and attack cancer cells. The therapy is personalized because it targets specific markers unique to each patient's cancer.

The study involves several steps. First, tumor tissue is collected from the patient to create the personalized ATL001 therapy. Before receiving ATL001, patients undergo a process called lymphodepletion, which involves medications to temporarily reduce the number of immune cells in the body. Then ATL001 is given through an infusion directly into the bloodstream. Some patients will also receive nivolumab in combination with ATL001.

Throughout the study, participants have regular check-ups and tests to monitor their health, assess any side effects, and evaluate how the cancer responds to treatment. The researchers will look at changes in tumor size and overall survival rates.

Investigational drugs being tested:

ATL001 is an experimental immunotherapy that uses specially designed T cells to recognize and attack cancer cells. These T cells target neoantigens, which are unique markers found on cancer cells. The therapy aims to enhance the immune system's ability to fight cancer.

Nivolumab (brand name OPDIVO) is an established immunotherapy medication classified as a checkpoint inhibitor. It works by blocking a protein called PD-1 on T cells, which helps the immune system better recognize and attack cancer cells. In this trial, nivolumab is being studied in combination with ATL001 to see if the two treatments together are more effective than ATL001 alone.

Summary

Currently, there is one clinical trial available for patients with desmoplastic melanoma, located in Spain. This trial represents an innovative approach to cancer treatment by combining personalized cell therapy with an established immunotherapy medication. The study is particularly focused on patients who have already received prior treatment with PD-1/PD-L1 inhibitors, offering a potential option for those whose cancer has progressed or remained stable despite previous therapy.

The trial uses advanced immunotherapy techniques, including personalized T cell therapy tailored to each patient's specific cancer characteristics. This approach reflects the growing trend in cancer treatment toward precision medicine that targets the unique features of individual tumors. The combination of ATL001 with nivolumab aims to maximize the immune system's ability to fight cancer through complementary mechanisms.