Nodular melanoma Trials in Disease

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

This trial is investigating a new approach to treating advanced melanoma that has spread to other parts of the body or has come back after previous treatment. The study combines a personalized immune cell therapy called ATL001 with a medication called nivolumab (known by the brand name OPDIVO).

Who can participate:

• Adults aged 18 years or older with metastatic or recurrent melanoma
• Patients with measurable disease and a life expectancy of at least 6 months
• Those who have previously received treatment with a PD-1/PD-L1 inhibitor and experienced either disease progression or stable disease after at least 4 doses
• Patients with a BRAF V600 mutation must have previously received targeted therapy for this mutation
• Performance status of 0-1, meaning patients are fully active or have some symptoms but can manage daily activities independently
• Adequate organ function confirmed through blood tests
• Women of childbearing potential must agree to use effective birth control during the study and for 12 months after receiving ATL001
• Patients must be medically fit to undergo all study procedures, including tissue collection and receiving the required medications

Who cannot participate:

• Patients with other types of cancer besides metastatic or recurrent melanoma
• Those who are pregnant or breastfeeding
• Patients unable to give informed consent or understand the study requirements
• Those currently participating in another clinical trial
• Patients who have recently had major surgery or are still recovering from it
• Those with a history of severe allergic reactions to similar treatments
• Patients with active infections requiring treatment
• Those with certain medical conditions that might interfere with the study or be worsened by the treatment
• Patients with a history of substance abuse that might interfere with the study

What the trial involves:

The study evaluates the safety and effectiveness of ATL001, a personalized therapy that uses a patient's own immune cells (specifically T cells) that have been modified to better recognize and attack cancer cells. These modified T cells are designed to target specific mutations found on cancer cells called neoantigens.

ATL001 is tested both alone and in combination with nivolumab. Nivolumab is a checkpoint inhibitor that works by blocking a protein called PD-1 on T cells, which helps the immune system recognize and attack cancer cells more effectively. Both medications are given through infusion directly into the bloodstream.

The trial follows a structured process. After confirming eligibility through medical history review and physical examination, tissue is collected from the tumor to create the personalized ATL001 therapy. Before receiving ATL001, patients undergo a process called lymphodepletion, which involves medications (fludarabine and cyclophosphamide) to temporarily reduce the number of immune cells in the body. This prepares the body to better accept the modified T cells.

Participants receive regular follow-up visits that include physical examinations, imaging tests, and laboratory tests to monitor their response to treatment and check for any side effects. The study monitors changes in tumor size and overall health throughout the treatment period.

Investigational drugs:

ATL001 is an immunotherapy agent that uses specially designed T cells to target and destroy melanoma cells. It aims to enhance the immune system's ability to fight cancer by activating T cells that recognize unique markers on cancer cells.

Nivolumab is an established checkpoint inhibitor used to treat various types of cancer, including melanoma. It helps the immune system fight cancer by blocking the PD-1 protein, which normally prevents immune cells from attacking cancer cells.

Summary

Currently, there is one clinical trial available for patients with nodular melanoma, specifically focusing on advanced cases where the disease has spread or returned. This trial is being conducted in Spain and represents an innovative approach combining personalized immune cell therapy with established checkpoint inhibitor treatment.

The study is particularly notable for its use of personalized medicine, where treatment is tailored to each individual patient using their own modified immune cells. This approach, combined with nivolumab, aims to provide a more targeted and potentially more effective treatment option for patients who have already received previous therapy with PD-1/PD-L1 inhibitors.

Patients interested in participating should discuss eligibility requirements with their healthcare provider, as the trial has specific criteria regarding previous treatments and overall health status.