A Study of Neoadjuvant Therapy With BCD-217 (Nurulimab + Prolgolimab) in Patients With Resectable Stage III Skin Melanoma — NEO-MIMAJOR  

Melanoma (Skin) Clinical Trial

Official title: A Randomized Study of the Efficacy and Safety of Neoadjuvant Therapy With BCD-217 (Nurulimab + Prolgolimab) Versus Standard Adjuvant Therapy With Pembrolizumab in Patients With Resectable Stage III Skin Melanoma.

Status Recruiting

Clinical Trial Summary

This study is an open-label, randomized, comparative phase III study, which will include subjects with resectable stage III skin melanoma (up to 3 resectable transient metastases are acceptable).

Clinical Trial Description

In both study groups, adjuvant therapy is possible until melanoma progresses to unresectable stage III-IV, unacceptable toxicity, withdrawal of ICF or the end of the therapy period (12 months).

In case of postoperative relapse of the disease, at the decision of the investigator and if the lesion is resectable, radical surgical treatment can be carried out (R0 - resection) in accordance with current clinical guidelines without withdrawing the patient from the study. ;

Related Conditions & MeSH terms

• Melanoma
• Melanoma (Skin)
• Melanoma Stage III

• NCT number: NCT05751928
• Study type: Interventional
• Source: Biocad
• Contact: Fedor B Kriukov, MD PhD
• Phone: +7 (812) 380 49 33
• Email: biocad@biocad.ru
• Status: Recruiting
• Phase: Phase 3
• Start date: March 2023
• Completion date: June 2027