Pre- and Post-Surgery Pembrolizumab for Melanoma

This trial tests the effectiveness of pembrolizumab, an immunotherapy, when used before and after surgery for individuals with high-risk melanoma, a type of skin cancer. The goal is to determine if using pembrolizumab both before and after surgery is more effective than using it only after surgery. Participants with stage III or IV melanoma that hasn't spread to the brain and is visible on scans or exams may be suitable candidates. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

The trial protocol does not specify if you need to stop taking your current medications. However, you must not receive any other biologic therapy, hormonal therapy, or chemotherapy while on the study. It's best to discuss your specific medications with the trial team.

Research shows that pembrolizumab, a treatment for melanoma, is generally safe. Studies have found that it remains safe for long-term use when given alone for advanced melanoma, with serious side effects uncommon for most patients.

The FDA has approved pembrolizumab for treating advanced melanoma, further confirming its safety. In a large study, most participants tolerated pembrolizumab well, indicating that severe problems are rare.

Unlike the standard care for melanoma, which often involves surgery followed by adjuvant treatment, pembrolizumab offers a unique approach by acting as both a neoadjuvant and adjuvant therapy. Pembrolizumab is a type of immunotherapy that works by unleashing the immune system to attack cancer cells, targeting the PD-1 pathway, which is different from traditional treatments like chemotherapy. Researchers are excited about this treatment because it could potentially shrink tumors before surgery, making them easier to remove, and help prevent the cancer from coming back after surgery. This dual approach aims to improve outcomes for patients with melanoma by using the body's own defenses in a more strategic manner.

Research has shown that pembrolizumab can help treat advanced melanoma. In one study, over one-third of patients with advanced melanoma were still alive 10 years after receiving pembrolizumab, outperforming those treated with ipilimumab. Another study found that pembrolizumab halted cancer progression in 43% of patients, compared to 32% with ipilimumab. Additionally, more patients experienced tumor shrinkage with pembrolizumab. In this trial, participants in Arm I will receive adjuvant pembrolizumab, while those in Arm II will receive both adjuvant and neoadjuvant pembrolizumab. The drug is also known to improve long-term survival and reduce the chance of cancer returning or spreading. Overall, pembrolizumab has shown promising results in aiding the body's immune system to fight melanoma.¹⁵⁶⁷⁸