Phase 2 Study of One Dose of Pembrolizumab Before Surgery in Adults With High-Risk Melanoma Without Signs of Spread

What this Trial Is About

Researchers are investigating whether a single dose of the immunotherapy drug pembrolizumab given before surgery can help the immune system better fight high-risk melanoma. This study focuses on adults whose melanoma has no visible signs of spreading on scans, aiming to see if early treatment can reduce microscopic cancer cells in the lymph nodes. The study is a Phase 2 clinical trial exploring the potential benefits of this neoadjuvant pre-surgery approach compared to standard post-surgery treatment. Participants receive one intravenous infusion of pembrolizumab six weeks before their scheduled sentinel lymph node biopsy and surgery. After surgery, patients with stage IIB, IIC, or III melanoma continue with standard immunotherapy every six weeks for one year. Those with stage IB or IIA melanoma proceed directly to follow-up care. The treatment plan includes surgery to remove the melanoma and check lymph nodes for cancer spread. During the five-year follow-up period, participants undergo regular physical exams, blood tests, and full-body imaging scans every four months to detect any recurrence of melanoma. Optional quality of life and cognitive function questionnaires are also included. Some participants may have blood tests to measure circulating tumor DNA, which could help predict relapse risk. Safety and treatment effects are closely monitored throughout the study.

A Phase II Clinical Trial on Neo-adjuvant Pembrolizumab in Patients With pT3b-T4a/b cN0M0 Melanoma.