Study of Daromun Neoadjuvant Intratumoral Treatment with Surgery and Adjuvant Therapy Versus Surgery and Adjuvant Therapy Alone in Patients with Stage IIIB, IIIC, or IIID Melanoma

What this Trial Is About

Researchers are evaluating the effectiveness of Daromun, a neoadjuvant intratumoral treatment, combined with surgery and adjuvant therapy compared to surgery and adjuvant therapy alone in patients with Stage IIIB, IIIC, or IIID melanoma. The study aims to determine if Daromun can significantly improve recurrence-free survival RFS in these patients. This is a Phase 3, open-label, randomized, controlled, multi-center trial involving 186 participants. Participants will be randomly assigned to one of two groups Arm 1 will receive Daromun injections directly into melanoma lesions once weekly for up to four weeks, followed by surgery within four weeks and then adjuvant therapy. Arm 2 will undergo surgery within four weeks after randomization followed by adjuvant therapy. Post-surgery adjuvant therapies are decided by the investigator and may include immunotherapy or targeted treatments. Throughout the study, participants will be followed for up to five years to assess recurrence-free survival, with additional survival data collected up to six years after randomization. Safety assessments include monitoring adverse events, laboratory tests, electrocardiograms, echocardiograms, physical exams, and vital signs. Tumor response will be evaluated during surgery. Participants will attend scheduled visits for treatment, monitoring, and follow-up to evaluate both the primary and secondary outcomes.

Efficacy of Daromun Neoadjuvant Intratumoral Treatment in Clinical Stage IIIB/C/D Melanoma Patients