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

NCT05751928 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 411

Last updated 2025-07-08

No results posted yet for this study

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).

Conditions

  • Melanoma Stage III
  • Melanoma (Skin)

Interventions

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.

Sponsors & Collaborators

  • Biocad

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-05
Primary Completion
2027-01-31
Completion
2027-06-30

Countries

  • Belarus
  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05751928 on ClinicalTrials.gov