Clinical Study of the Efficacy and Safety of BCD-201 and Keytruda in Subjects With Advanced Melanoma

September 18, 2023 updated by: Biocad

A Randomized, Double-Blind Clinical Study of the Efficacy and Safety of BCD-201 (JSC BIOCAD) and Keytruda® in Patients With Unresectable or Metastatic Melanoma

This clinical study is designed as a randomized, double-blind trial. Subjects with unresectable, metastatic, or recurrent skin melanoma will be randomized to one of the two study groups (BCD-201 group and Keytruda group) at a 1:1 ratio.

The goal of this study is to compare the efficacy and safety of BCD-201 and Keytruda as first-line therapy in subjects with unresectable, metastatic, or recurrent skin melanoma.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
366

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Russian Federation
      • Omsk, Russian Federation
        • Budgetary healthcare institution of the Omsk region "Clinical oncological dispensary"
      • Saint Petersburg, Russian Federation
        • "Saint Petersburg Clinical Research and Practice Center for Specialized Medical Care (Oncology)"
      • Saint Petersburg, Russian Federation
        • Federal State Budgetary Educational Institution of Higher Education "Saint Petersburg State University"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Signed informed consent;
  • Histologically confirmed melanoma;
  • Tumor first detected at the stage of advanced unresectable or metastatic disease, or disease progressing during or recurring after previous radical therapy;
  • ECOG score 0-1;
  • At least one measurable lesion according to RECIST 1.1;
  • Laboratory test results consistent with adequate functioning of systems and organs;
  • Willingness of men and women of childbearing potential to use highly effective contraceptive methods from the signing of the informed consent form, throughout the study and for 6 months after the administration of the last product dose.

Exclusion Criteria:

  • Indications for radical therapy (surgery, radiation therapy);
  • Uveal, ocular or mucosal melanoma;
  • Active CNS metastases and/or carcinomatous meningitis;
  • Subjects with severe concomitant disorders, life-threatening acute complications of the primary disease;
  • Concomitant diseases and/or conditions that significantly increase the risk of AEs during the study;
  • Active, known or suspected autoimmune disorders (subjects with type 1 diabetes mellitus or hypothyroidism requiring only hormone-replacement therapy and those with skin disorders [vitiligo, alopecia, or psoriasis] not requiring systemic therapy are eligible to participate);
  • The need for therapy with glucocorticoids or any other drugs with immunosuppressive effects within 14 days prior to randomization;
  • History of (non-infectious) pneumonitis requiring glucocorticoid therapy or pneumonitis at the time of screening;
  • Hypersensitivity or allergy to any of the pembrolizumab product components;
  • Pregnancy or breastfeeding, as well as intention to become pregnant or father a child during the study period.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: BCD-201 group
BCD-201 200 mg as a 30-minute intravenous infusion once every 3 weeks
Drug: BCD-201
up to 8 treatment cycles
Other Names:
  • Pembrolizumab
Active Comparator: Keytruda
Keytruda 200 mg as a 30-minute intravenous infusion once every 3 weeks
Drug: Keytruda
up to 8 treatment cycles
Other Names:
  • pembrolizumab

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
To compare the overall response rate (ORR) in the BCD-201 group and the Keytruda group
Time Frame: 24 weeks of treatment
ORR according to RECIST 1.1
24 weeks of treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To compare the ORR according to iRECIST in the BCD-201 group and the Keytruda group
Time Frame: every 12 weeks up to 2 years
ORR according to iRECIST
every 12 weeks up to 2 years
To compare the duration of response in the BCD-201 group and the Keytruda group
Time Frame: up to 2 years
Duration of response will be calculated from the moment of registration of response till event (progression or death)
up to 2 years
To compare the time to response according to RECIST 1.1 and iRECIST in the BCD-201 group and the Keytruda group
Time Frame: every 12 weeks up to 2 years
time to response will be calculated from the randomization date
every 12 weeks up to 2 years
To compare the disease control rate in the BCD-201 group and the Keytruda group
Time Frame: up to 2 years
The percentage of the participants who have a Complete Response, a Partial Response or a Stable DIsease
up to 2 years
To compare the progression-free survival (PFS) per RECIST 1.1 and iRECIST in the BCD-201 group and the Keytruda group
Time Frame: up to 2 years
The time from the date of randomization until progression of disease according to RECIST 1.1 / iRECIST criteria or death
up to 2 years
To compare the overall survival in the BCD-201 group and the Keytruda group
Time Frame: up to 2 years
The time from the date of randomization until death
up to 2 years
To compare the incidence of Treatment-Emergent Adverse Events (Safety profiles of BCD-201 and Keytruda)
Time Frame: through study completion, an average of 2 years.
Presence of any adverse events (AEs), presence of adverse reactions (ARs), presence of serious adverse reactions (SARs), presence of severe ARs (grade 3 or higher severity according to CTCAE v.5.0), presence of ARs leading to discontinuation of study therapy, presence of immune-mediated AEs
through study completion, an average of 2 years.
Area under the concentration-time curve (AUC(0-504))
Time Frame: up to 24 weeks of the double-blind treatment period
Area under the plasma concentration versus time curve in the time interval from 0 to 504 hours
up to 24 weeks of the double-blind treatment period
AUC(0-∞)
Time Frame: up to 24 weeks of the double-blind treatment period
Area under the plasma concentration versus time curve in the time interval from 0 to time infinity
up to 24 weeks of the double-blind treatment period
Peak Plasma Concentration (Cmax)
Time Frame: up to 24 weeks of the double-blind treatment period
maximum concentration of pembrolizumab
up to 24 weeks of the double-blind treatment period
Time to maximum concentration (Tmax)
Time Frame: up to 24 weeks of the double-blind treatment period
time to maximum concentration of pembrolizumab
up to 24 weeks of the double-blind treatment period
Elimination rate constant (kel)
Time Frame: up to 24 weeks of the double-blind treatment period
kel of pembrolizumab
up to 24 weeks of the double-blind treatment period
Total clearance (Cl)
Time Frame: up to 24 weeks of the double-blind treatment period
Cl of pembrolizumab
up to 24 weeks of the double-blind treatment period
Steady-state volume of distribution of the drug substance (Vd)
Time Frame: up to 24 weeks of the double-blind treatment period
Vd of pembrolizumab
up to 24 weeks of the double-blind treatment period
Half-life period (T1/2)
Time Frame: up to 24 weeks of the double-blind treatment period
T1/2 of pembrolizumab
up to 24 weeks of the double-blind treatment period
Concentrations at the end of each infusion (CEOI)
Time Frame: up to 24 weeks of the double-blind treatment period
concentrations at the end of each infusion of pembrolizumab
up to 24 weeks of the double-blind treatment period
To compare the immunogenicity of BCD-201 and Keytruda.
Time Frame: pre-dose to day169 of the double-blind treatment period, 8 timepoints
Development of binding and neutralizing antibodies to pembrolizumab
pre-dose to day169 of the double-blind treatment period, 8 timepoints

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biocad

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 18, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 13, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 14, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 21, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BCD-201-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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