Ongoing Clinical Trials for Superficial Spreading Melanoma Stage Unspecified

Currently, there is 1 ongoing clinical trial focused on superficial spreading melanoma stage unspecified. This trial is exploring a personalized immune cell therapy combined with an established immunotherapy drug to help the body fight this type of skin cancer. The trial is taking place in Spain and is designed to evaluate both safety and effectiveness of this treatment approach for patients whose melanoma has spread or returned after previous treatment.

Clinical trial locations

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

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

This clinical trial is testing a new treatment approach for patients whose melanoma has spread to other parts of the body or has returned after previous treatment. The study combines two treatments: a personalized immune cell therapy called ATL001 and an immunotherapy drug called nivolumab (also known by the brand name OPDIVO).

Main inclusion criteria:

• Adults aged 18 years or older
• Confirmed diagnosis of metastatic or recurrent melanoma
• Life expectancy of at least 6 months
• Previously received treatment with PD-1/PD-L1 inhibitor medications and experienced either disease progression or stable disease after at least 4 doses
• For patients with a specific BRAF V600 mutation, prior treatment with targeted therapy for this mutation is required
• Good enough overall health status to undergo study procedures, including blood and tissue collection
• Performance status of 0-1, meaning patients are fully active or have some symptoms but can still care for themselves
• Adequate organ function as shown by blood tests
• Women of childbearing potential and male patients must agree to 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
• Unable to provide informed consent
• Pregnancy or breastfeeding
• Currently participating in another clinical trial
• Recent major surgery or still recovering from surgery
• History of severe allergic reactions to similar treatments
• Active infection requiring treatment
• History of substance abuse that might interfere with the study
• Certain medical conditions that could be worsened by the study treatment

Focus and goal of the trial:

The main purpose of this study is to evaluate the safety and effectiveness of ATL001, both alone and in combination with nivolumab. ATL001 is a personalized therapy created using the patient’s own immune cells, specifically T cells, which are modified to better recognize and attack cancer cells. The process involves several steps:

1. Initial assessment: Medical history review and physical examination to confirm eligibility, including blood and tumor tissue sample collection
2. Tissue collection: A procedure (possibly requiring general anesthetic) to obtain tumor tissue, which is then used to create the personalized ATL001 therapy
3. Lymphodepletion: Before receiving ATL001, patients receive medications (fludarabine and cyclophosphamide) to temporarily reduce the number of immune cells in the body, preparing it for the new therapy
4. ATL001 infusion: The personalized therapy is delivered directly into the bloodstream through a vein
5. Combination therapy: In some cases, patients also receive nivolumab infusions, which help the immune system attack cancer cells by blocking a protein that normally stops this response
6. Regular monitoring: Follow-up visits with physical examinations, imaging tests, and laboratory tests to assess treatment response and side effects

The study will monitor how well the cancer responds to treatment, including changes in tumor size and overall survival rates. This research is expected to continue until July 31, 2027.

Investigational drugs being tested:

ATL001 is a personalized immunotherapy using specially modified T cells that are designed to recognize unique markers on cancer cells called neoantigens. These modified immune cells aim to enhance the body’s natural ability to target and destroy melanoma cells. The therapy is administered through intravenous infusion in a clinical setting.

Nivolumab is an established checkpoint inhibitor medication that works by blocking the PD-1 protein on T cells. By blocking this protein, nivolumab removes a brake on the immune system, allowing it to more effectively recognize and attack cancer cells. It is also given as an intravenous infusion in a hospital or clinic setting.

Summary

Currently, there is one clinical trial available for patients with superficial spreading melanoma stage unspecified, specifically focusing on cases where the disease has spread or returned after previous treatment. This trial is being conducted in Spain and represents a modern approach to cancer treatment by combining personalized immune cell therapy with an established immunotherapy drug. The study requires patients to have already received prior treatment with PD-1/PD-L1 inhibitors and focuses on those who have experienced disease progression or stable disease after such treatment. The personalized nature of ATL001, which is created specifically for each patient using their own tumor tissue, represents an innovative approach in melanoma treatment. Patients interested in this trial should discuss their eligibility with their healthcare provider, as the study involves multiple treatment steps and requires adequate organ function and overall health status.