NCT03913923

Brief Summary

This is a multicenter randomized double-blind placebo-controlled phase II clinical trial. The purpose of this trial is to evaluate efficacy and safety of therapy consisting of BCD-217 (fixed dose combination of anti-CTLA-4 and anti-PD-1 monoclonal antibodies) and sequential BCD-100 (anti-PD-1 monoclonal antibody) versus BCD-100 monotherapy as first-line treatment in patients with treatment-naïve unresectable or metastatic melanoma.

Trial Health

47
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
117

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2019

Typical duration for phase_2

Geographic Reach
2 countries

23 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

April 11, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 12, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2019

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

February 10, 2023

Status Verified

February 1, 2023

Enrollment Period

4 years

First QC Date

April 11, 2019

Last Update Submit

February 8, 2023

Conditions

MelanomaMelanoma Metastatic

Outcome Measures

Primary Outcomes (1)

  • Median Progression-Free Survival

    2 years

Secondary Outcomes (6)

  • Progression-Free Survival (PFS)

    2 years

  • Overall Survival (OS)

    2 years

  • Overall Response Rate

    2 years

  • Disease Control Rate

    2 years

  • Time to Response (TTR)

    2 years

  • +1 more secondary outcomes

Study Arms (2)

BCD-217 and BCD-100

EXPERIMENTAL

Patients will receive 4 blinded infusions of BCD-217 plus Placebo. Starting with the fith infusion patients will receive unblinded BCD-100 monotherapy.

Biological: BCD-217Biological: BCD-100Other: Placebo

BCD-100 monotherapy

ACTIVE COMPARATOR

Patients will receive 4 blinded infusions of BCD-100 plus Placebo. Starting with the fith infusion patients will receive unblinded BCD-100 monotherapy.

Biological: BCD-100Other: Placebo

Interventions

BCD-217BIOLOGICAL

Combination of anti-CTLA-4 and anti-PD-1 monoclonal antibodies, 1mg/kg and 3 mg/mg, respectively, given Q3W as IV infusion for first 4 blinded infusions

BCD-217 and BCD-100
BCD-100BIOLOGICAL

Anti-PD-1 monoclonal antibody, 3 mg/kg, given Q3W as IV infusion for first 4 blinded infusions, after - 1 mg/kg, given Q2W as IV infusion

BCD-100 monotherapyBCD-217 and BCD-100
PlaceboOTHER

Placebo

BCD-100 monotherapyBCD-217 and BCD-100

Eligibility Criteria

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

You may qualify if:

  • Signed Informed Consent Form and the subject's ability to follow the Protocol requirements;
  • Age: 18 years and older at the signing of the informed consent;
  • Histologically verified (documented) melanoma;
  • Previously untreated unresectable stage III melanoma or metastatic stage IV melanoma;
  • Available tissue blocks for histological examination or patient's agreement to give biopsy specimens
  • Patient's consent for PD-L1 expression status and BRAF V600 testing;
  • ECOG performance status of 0 or 1;
  • Life expectancy of at least 12 weeks from the screening;
  • At least one RECIST 1.1-defined measurable target lesion confirmed by an independent review;
  • Patients with reproductive potential must agree to practice acceptable methods of birth control throughout the entire trial period, starting from signing the informed consent and up to 24 weeks after the last dose of investigational drug.

You may not qualify if:

  • Indications for radical (surgical, radiation) therapy;
  • A history of previous systemic antitumor therapy for unresectable or metastatic melanoma ;
  • 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;
  • Use of immunostimulants, monoclonal antibodies and/or colony-stimulating factors within less than 4 weeks prior to randomization in the study;
  • Ocular melanoma;
  • Mucosal melanoma;
  • CNS metastases;
  • Impossibility to determine PD-L1 status and/or BRAF status;
  • Subjects with severe comorbidities, life-threatening acute complications of the primary disease (including massive pleural, pericardial, or peritoneal effusions requiring intervention , pulmonary lymphangitis, bleeding, or organ perforation) at the time of signing the informed consent form;
  • Ongoing concomitant diseases at the time of screening, which increase the risk of severe adverse events during the administration of the study therapy:
  • 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 heart failure (classes III and IV according to NYHA classification);
  • uncontrolled hypertension (systolic blood pressure \>150 mmHg or diastolic blood pressure \>90 mmHg) ;
  • +25 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

State Institution "N.N. Aleksandrov Republican Research and Practical Center for Oncology and Medical Radiology"

The Settlement of Lesnoy, Minsk District, Belarus

Location

Healthcare Institution "Minsk Municipal Clinical Oncolo-gy Dispensary" (MMCOD)

Minsk, 220013, Belarus

Location

Clinical Oncologic Dispensary No. 2

Sochi, Krasnodar Territory, 354057, Russia

Location

Krasnoyarsk Regional Clinical Oncological Dispensary named after A.I. Kryzhanovsky

Krasnoyarsk, Krasnoyarsk Krai, 660133, Russia

Location

Murmansk Regional Clinical Hospital named after P.A. Bayandina

Murmansk, Murmansk Oblast, 183047, Russia

Location

LLC "New Clinic"

Pyatigorsk, Stavropol Kray, 357500, Russia

Location

Regional Clinical Oncology Hospital

Yaroslavl, Yaroslavl Oblast, 150054, Russia

Location

State Budgetary Healthcare Institution of the Ar-khangelsk Region "Arkhangelsk Clinical Oncology Dispensary"

Arkhangelsk, 163045, Russia

Location

Territorial State Budgetary Healthcare Institution "Altai Territorial Clinical Oncology Dispensary"

Barnaul, 656045, Russia

Location

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

Chelyabinsk, 454087, Russia

Location

State public health institution "Republican Clinical Oncology Dispensary" of the Ministry of Health of the Republic of Tatarstan

Kazan', Russia

Location

Regional State Budgetary of Healthcare Insti-tution "Kostroma Oncology Dispensary"

Kostroma, Russia

Location

Medsi Group of Companies Joint-Stock Company

Moscow, 123056, Russia

Location

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

Moscow, Russia

Location

State Health Care Institution "Moscow City Oncology Hospital № 62" Moscow Health Department

Moscow, Russia

Location

State Budgetary Healthcare Institution of the Novosi-birsk Region "Novosibirsk Regional Clinical Oncolo-gy Dispensary"

Novosibirsk, 630108, Russia

Location

State budget healthcare institution Omsk region "Clinical Oncology Dispensary"

Omsk, Russia

Location

JSC "Modern Medical Technologies"

Saint Petersburg, 190013, Russia

Location

AV Medical Group Limited Liability Company

Saint Petersburg, 197082, Russia

Location

Federal State Institution "N.N. Petrov National Medical Research Center for Oncology"

Saint Petersburg, 197758, Russia

Location

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

Saint Petersburg, 197758, Russia

Location

Federal State Budgetary Educational Institution of Higher Education "St. Petersburg State University"

Saint Petersburg, 199106, Russia

Location

State-financed Health Institution "Samara Region Clinical Oncology Dispansary"

Samara, 443031, Russia

Location

MeSH Terms

Conditions

Melanoma

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 Officials

  • Arina V Zinkina-Orikhan, PhD

    Director of Clinical Development Department, BIOCAD

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2019

First Posted

April 12, 2019

Study Start

July 1, 2019

Primary Completion

July 1, 2023

Study Completion

December 1, 2023

Last Updated

February 10, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

BE(2)RU(21)