NCT05751928

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

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: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 411 (actual)
• Sponsor: Biocad · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Melanoma Stage III
• Melanoma (Skin)

Interventions

Type	Name	Description
BIOLOGICAL	BCD-217	BCD-217 (anti-CTLA4 agent nurulimab + anti-PD1) once every 3 weeks in the neoadjuvant setting
BIOLOGICAL	anti-PD1	anti-PD1 agent in the adjuvant setting
PROCEDURE	Excision of the primary lesion	Excision of the primary lesion will be performed per standard of care.
PROCEDURE	Regional lymphadenectomy	Regional lymphadenectomy will be performed per standard of care.

Timeline

• Start date: 2023-04-05
• Primary completion: 2027-01-01
• Completion: 2027-06-01
• First posted: 2023-03-02
• Last updated: 2025-07-08

Locations

36 sites across 2 countries: Belarus, Russia