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

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: Active, not recruiting
• Conditions: Melanoma (Skin)
• Intervention / Treatment: Drug: BCD-201; Drug: Keytruda

• Study Type: Interventional
• Enrollment (Actual): 366
• Phase: Phase 3

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
To compare the overall response rate (ORR) in the BCD-201 group and the Keytruda group	ORR according to RECIST 1.1	24 weeks of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To compare the ORR according to iRECIST in the BCD-201 group and the Keytruda group	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	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 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	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	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	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)	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))	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-∞)	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)	maximum concentration of pembrolizumab	up to 24 weeks of the double-blind treatment period
Time to maximum concentration (Tmax)	time to maximum concentration of pembrolizumab	up to 24 weeks of the double-blind treatment period
Elimination rate constant (kel)	kel of pembrolizumab	up to 24 weeks of the double-blind treatment period
Total clearance (Cl)	Cl of pembrolizumab	up to 24 weeks of the double-blind treatment period
Steady-state volume of distribution of the drug substance (Vd)	Vd of pembrolizumab	up to 24 weeks of the double-blind treatment period
Half-life period (T1/2)	T1/2 of pembrolizumab	up to 24 weeks of the double-blind treatment period
Concentrations at the end of each infusion (CEOI)	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.	Development of binding and neutralizing antibodies to pembrolizumab	pre-dose to day169 of the double-blind treatment period, 8 timepoints

Collaborators and Investigators

• Sponsor: Biocad

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2022
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: February 13, 2023
• First Submitted That Met QC Criteria: August 1, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 18, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Pembrolizumab
• Other Study ID 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