Stage IV Melanoma Clinical Trials 2023

What are Stage IV Melanoma Clinical Trials?

Stage IV (stage 4) melanoma is a melanoma that has spread to other body parts such as the lungs, liver, brain, and gastrointestinal tract. It is also called distant metastatic melanoma.

Melanoma is a type of skin cancer resulting from the abnormal growth of melanocytes, the skin cells that produce the skin pigment melanin. This type of skin cancer has been linked to ultraviolet radiation in sunlight or tanning beds, which damages the melanocytes and leads to tumor growth.

It is one of the deadliest forms of skin cancer because of the speed at which it can spread, unlike other common skin cancers like squamous or basal cell carcinoma.

Once a patient reaches stage 4, it is challenging to treat as there are now growths in multiple areas of the body. Healthcare providers use a combination of therapies to stop cancer and prolong a patient's life.

Why Is Stage IV Melanoma Being Studied Through Clinical Trials?

Melanoma is one of the top 10 prevalent cancers in the US, with nearly 100,000 diagnosed in 2023 and approximately 7,600 dying from complications.

Even though it is commonly seen in lighter-skinned individuals, people with dark skin tones can still be diagnosed with it. Estimates suggest that 1 in every 50 Americans will be diagnosed with melanoma.

If diagnosed early, a patient has a 70 – 90% chance of five-year survival. However, once it has reached stage IV and metastases, this rate drops to 32%. For patients at this late stage, clinical trials are their last hope as they provide treatment options when standard ones have failed.

These trials also give healthcare providers vital information about the safety and effectiveness of new therapies that can treat melanomas in their early stages.

What Treatment is Available for Stage IV Melanoma?

As stage IV melanoma has spread to other organs, the treatment is focused on slowing the spread and shrinking tumors. Enlarged lymph nodes and skin tumors causing symptoms are removed via surgery, but it may not be possible for growth in other organs.

In such cases, a combination of radiation, immunotherapy, targeted therapy, or chemotherapy is used. Doctors often recommend that patients with stage IV melanoma enroll in clinical trials.

The side effects of these aggressive treatments are severe and can drastically affect a patient's quality of life. Some may find it too difficult to bear and instead opt to just focus on pain management and other palliative care.

What are Some Recent Stage IV Melanoma Clinical Trial Breakthroughs?

2023: This clinical trial studied the effects of pembrolizumab as an adjuvant therapy in resected distant metastatic melanoma. 976 patients were enrolled to test the effects and safety of this immunotherapy against a placebo. Pembrolizumab was found to be effective when compared to a placebo.

2018: This long-term clinical trial studied the effectiveness of the combination nivolumab + ipilimumab against two control groups, nivolumab + placebo, and double placebo, as a post-surgical/post-radiation treatment for stage IV melanoma with no remission. Five-year findings showed the active regimen significantly improved recurrence-free survival.