NCT05751928

Brief 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).

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
411

participants targeted

Target at P50-P75 for phase_3

Timeline
13mo left

Started Apr 2023

Typical duration for phase_3

Geographic Reach
2 countries

36 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress74%
Apr 2023Jun 2027

First Submitted

Initial submission to the registry

February 21, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 2, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

April 5, 2023

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

July 8, 2025

Status Verified

July 1, 2025

Enrollment Period

3.7 years

First QC Date

February 21, 2023

Last Update Submit

July 7, 2025

Conditions

Melanoma Stage IIIMelanoma (Skin)

Keywords

PD-1CTLA-4prolgolimabnurulimabimmunotherapycheckpoint inhibitorsCPIprogramm deathcytotoxic T-lymphocyte-associated proteinNeoadjuvant MelanomaAdjuvant Melanoma

Outcome Measures

Primary Outcomes (1)

  • event free survival (EFS)

    24 months

Secondary Outcomes (10)

  • overall survival (OS)

    24 months

  • distant metastases-free survival (DMFS)

    24 months

  • pathologic response rate (pRR)

    24 months

  • The proportion of subjects with treatment-related adverse events;

    24 months

  • The proportion of subjects experiencing any grade 3 or higher adverse events

    24 months

  • +5 more secondary outcomes

Study Arms (3)

Subjects with pCR and pnCR (Group 1A)

EXPERIMENTAL

Subjects will receive 2 cycles of BCD-217 neoadjuvant therapy, followed by index lymph node removal. Subjects with pathological complete (pCR) and near complete response (pnCR) (Group 1A): excision of the primary lesion (if not previously performed) without regional lymphadenectomy, followed by up to 12 months of anti-PD1 agent in the adjuvant setting.

Biological: BCD-217Biological: anti-PD1Procedure: Excision of the primary lesion

Subjects with a pPR or pNR to neoadjuvant therapy (Group 1B)

EXPERIMENTAL

Subjects will receive 2 cycles of BCD-217 neoadjuvant therapy, followed by index lymph node removal. Subjects with a pathological partial response (pPR) or non-responders (pNR) to neoadjuvant therapy (Group 1B): excision of the primary lesion (if not performed earlier), regional lymphadenectomy, then up to 12 months of adjuvant therapy with anti-PD1 agent.

Biological: BCD-217Biological: anti-PD1Procedure: Excision of the primary lesionProcedure: Regional lymphadenectomy

Control Group (Group 2)

ACTIVE COMPARATOR

Subjects start treatment with excision of the primary lesion (if not previously performed), regional lymphadenectomy followed by adjuvant therapy with anti-PD1 agent (up to 12 months). This approach is considered the standard therapy for patients in the target population.

Procedure: Excision of the primary lesionProcedure: Regional lymphadenectomy

Interventions

BCD-217BIOLOGICAL

BCD-217 (anti-CTLA4 agent nurulimab + anti-PD1) once every 3 weeks in the neoadjuvant setting

Also known as: nurulimab+prolgolimab
Subjects with a pPR or pNR to neoadjuvant therapy (Group 1B)Subjects with pCR and pnCR (Group 1A)
anti-PD1BIOLOGICAL

anti-PD1 agent in the adjuvant setting

Subjects with a pPR or pNR to neoadjuvant therapy (Group 1B)Subjects with pCR and pnCR (Group 1A)
Excision of the primary lesionPROCEDURE

Excision of the primary lesion will be performed per standard of care.

Control Group (Group 2)Subjects with a pPR or pNR to neoadjuvant therapy (Group 1B)Subjects with pCR and pnCR (Group 1A)
Regional lymphadenectomyPROCEDURE

Regional lymphadenectomy will be performed per standard of care.

Control Group (Group 2)Subjects with a pPR or pNR to neoadjuvant therapy (Group 1B)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed informed consent and the subject's ability to comply with the requirements of the clinical study protocol;
  • Age ≥ 18 years at the time of signing the informed consent form;
  • Histologically or cytologically confirmed (documented results of relevant studies are available) resectable stage IIIB/C/D skin melanoma;
  • At least one clinically detectable lymph node accessible for biopsy and not more than three resectable in-transit metastases .
  • Clinically detectable lymph nodes include:
  • Palpable lymph nodes with pathologically confirmed melanoma
  • Non-palpable but enlarged (≥15 mm in smallest diameter, RECIST 1.1) lymph nodes with pathologically confirmed melanoma
  • Subject's consent to a biopsy;
  • Consent to the evaluation of the PD-L1 status and BRAF V600 mutation status ;
  • ECOG score 0-1;
  • Life expectancy of at least 5 years;
  • Willingness of subjects and their sexual partners of childbearing potential to use reliable methods of contraception from the date of signing the informed consent form throughout the study period and for 24 weeks after the administration of the last dose of the investigational therapy.

You may not qualify if:

  • Ocular melanoma;
  • Mucosal melanoma;
  • Distant metastases;
  • Impossibility of radical resection of the tumor, metastasis and/or involved lymph nodes;
  • Presence of only in-transit transit/satellite metastases without confirmed involvement of lymph nodes;
  • Prior therapy with checkpoint inhibitors (e.g. anti-CTLA-4 and/or anti-PD-1/PD-L1/PD-L2 products);
  • Prior therapy with BRAF and MEK protein kinase inhibitors;
  • Prior radiation therapy;
  • Inability to determine BRAF status;
  • Subjects with severe comorbidities, with life-threatening acute complications of the underlying disease at the time of signing the informed consent form;
  • Current concomitant diseases at the time of screening, which increase the risk of severe adverse events during surgery and/or study therapy administration;
  • stable angina, functional class III-IV;
  • unstable angina or a history of myocardial infarction within less than 6 months prior to signing the informed consent form;
  • moderate to severe cardiac failure (NYHA classes III and IV);
  • uncontrolled hypertension (systolic blood pressure \>150 mmHg or diastolic blood pressure \>90 mmHg) ;
  • +26 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (36)

State Institution "Republican Scientific and Practical Center of Oncology and Medical Radiology named after A.I. N.N. Alexandrov"

Lesnoy, Belarus

Location

Healthcare Institution "Minsk City Clinical Cancer Center"

Minsk, 220013, Belarus

Location

State Institution "Mogilev Regional Oncological Dispensary"

Mogilev, Belarus

Location

Healthcare Institution "Vitebsk Regional Clinical Oncology Center"

Vitebsk, Belarus

Location

Clinical Oncologic Dispensary No. 1

Krasnodar, Krasnodar Kari, 350040, Russia

Location

Clinical Oncologic Dispensary No. 2

Sochi, Krasnodar Territory, 354057, Russia

Location

Regional Clinical Oncology Hospital

Yaroslavl, Yaroslavl Oblast, 150054, Russia

Location

State Budgetary Healthcare Institution "Chelyabinsk Regional Clinical Center for Oncology and Nuclear Medicine",

Chelyabinsk, 454087, Russia

Location

State budgetary healthcare institution Leningrad Regional Clinical Hospital

Gatchina, Russia

Location

State Autonomous Health Institution "Republican Clinical Oncology Dispensary of the Ministry of Health of the Republic of Tatarstan named after Professor M.Z. Sigal"

Kazan', Russia

Location

State budgetary health care institution "Kuzbass clinical oncological dispensary named after M.S. Rappoport"

Kemerovo, Russia

Location

Regional Goverment Budgetary Healthcare State "Kostroma Oncology Center"

Kostroma, 156005, Russia

Location

State Budgetary Institution of Healthcare "Leningrad Regional Clinical Oncological Dispensary named after V.I. L.D. Romana"

Kuz'molovskiy, Russia

Location

"Russian Cancer Research Center named after N.N. Blokhin "of the Ministry of Health of the Russian Federation

Moscow, Russia

Location

Branch of Hadassah Medical LTD Limited Liability Company

Moscow, Russia

Location

Federal State Autonomous Educational Institution of Higher Education I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University)

Moscow, Russia

Location

Joint Stock Company "K31 City"

Moscow, Russia

Location

JSC "Medsi Group"

Moscow, Russia

Location

Moscow City Oncology Hospital No. 62

Moscow, Russia

Location

State budgetary health care institution of the city of Moscow "City Clinical Oncology Hospital No. 1 of the Department of Health of the City of Moscow"

Moscow, Russia

Location

Nizhny Novgorod Region State Budgetary Healthcare Facility "Clinical Diagnostics Center"

Nizhny Novgorod, 603006, Russia

Location

LLC "DobroMed"

Novosibirsk, Russia

Location

State Budgetary Healthcare Institution "Novosibirsk Regional Clinical Oncology Center" of the Novosibirsk Region

Novosibirsk, Russia

Location

Federal State Budgetary Institution "National Medical Research Center for Radiology" of the Ministry of Health of the Russian Federation

Obninsk, Russia

Location

Budgetary healthcare institution of the Omsk region "Clinical oncological dispensary"

Omsk, Russia

Location

JSC "Modern Medical Technologies"

Saint Petersburg, 190013, Russia

Location

Saint-Petersburg Petersburg Clinical Scientific and Practical Center for Specialized Types of Medical Care (Oncological)

Saint Petersburg, 197758, Russia

Location

City Hospital #40, Kurortny district

Saint Petersburg, Russia

Location

Federal State Budgetary Educational Institution of Higher Education "Saint Petersburg State University"

Saint Petersburg, Russia

Location

Limited Liability Company "American Medical Clinic"

Saint Petersburg, Russia

Location

Limited Liability Company "Oncological Research Center"

Saint Petersburg, Russia

Location

Limited Liability Company "Strategic Medical Systems"

Saint Petersburg, Russia

Location

N.N. Petrov National Medicine Research Center of oncology

Saint Petersburg, Russia

Location

Private Medical Institution Evromedservis

Saint Petersburg, Russia

Location

Federal State Educational Institution of Higher Professional Education "Mordovia State University N.P. Ogareva "

Saransk, Russia

Location

State Health Care Institution "Volgograd Regional Clinical Oncology Dispensary â„– 1"

Volgograd, Russia

Location

MeSH Terms

Conditions

MelanomaDiabetes Mellitus, Insulin-Dependent, 12

Interventions

spartalizumab

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2023

First Posted

March 2, 2023

Study Start

April 5, 2023

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

July 8, 2025

Record last verified: 2025-07

Locations

RU(32)BE(4)