Phase II Study of Intratumoral Ipilimumab and Nivolumab as Neoadjuvant Treatment for Resectable Stage III Cutaneous and Mucosal Melanoma

What this Trial Is About

Researchers are investigating a new approach for treating patients with localized stage III resectable cutaneous or mucosal melanoma. This phase II clinical trial tests the safety and effectiveness of combining two immunotherapy drugs, ipilimumab and nivolumab, administered directly into the tumor before surgery. This approach aims to stimulate the immune system to attack the cancer while reducing the side effects often seen with standard intravenous treatments. In this study, participants will receive up to three doses of ipilimumab and nivolumab through intratumoral injections spaced about three weeks apart, over a period of up to six weeks before their surgery. The injections use image guidance, preferably ultrasound, to precisely deliver the drugs into the tumor. This method intends to increase drug concentration at the tumor site and minimize systemic exposure that can cause adverse events. Participants will provide fresh blood and tumor samples at the beginning and during treatment to help researchers understand the immune response and identify biomarkers predicting treatment success. The main outcomes measured include how well the tumor responds to the treatment and the tolerability of the drug combination, assessed between 6 and 8 weeks after treatment ends. The total study duration spans from initial dosing through surgery and follow-up assessments.

Neo-adjuvant Immunotherapy in Patients With Localized Melanoma