Neo-adjuvant Intratumoral Anti-CTLA4 and Anti-PD1 Immunotherapy in Patients With Localized Resectable Stage III Melanoma

What this Trial Is About

Researchers are evaluating a new approach to treat patients with resectable stage III cutaneous or mucosal melanoma using intratumoral injections of ipilimumab (an anti-CTLA-4 antibody) combined with nivolumab (an anti-PD-1 antibody). This phase II, open-label, multicenter trial aims to maximize the effectiveness of this combined immunotherapy while minimizing systemic side effects seen with intravenous administration. The NEO-1 study uses a neoadjuvant strategy, meaning treatment is given before surgery, and includes detailed immune profiling to better understand patient responses. Participants will receive up to three doses of ipilimumab and nivolumab directly into their tumors at three-week intervals, over a period of about six weeks before surgery. The injections are guided by imaging, primarily ultrasound, to target the tumor precisely. This intratumoral delivery is expected to increase drug concentration at the tumor site and reduce systemic toxicity. The study is a sub-protocol of the larger NEOREM master protocol, which supports comprehensive immune monitoring. During the study, patients will undergo blood and tumor sample collection at baseline and throughout treatment to profile their immune status and tumor environment. Researchers will assess the primary outcomes of treatment effectiveness, focusing on complete or major pathological response, and tolerability by monitoring adverse events between six and eight weeks after treatment ends. Participation involves close monitoring and follow-up to evaluate both safety and the biological effects of the therapy.

Neo-adjuvant Immunotherapy in Patients With Localized Melanoma