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

Biocad3 sites in 1 country366 target enrollmentJuly 18, 2022

ConditionsMelanoma (Skin)

InterventionsBCD-201 Keytruda

DrugsBCD-201 Keytruda

Overview

Phase: Phase 3
Intervention: BCD-201
Conditions: Melanoma (Skin)
Sponsor: Biocad
Enrollment: 366
Locations: 3
Primary Endpoint: To compare the overall response rate (ORR) in the BCD-201 group and the Keytruda group
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

July 18, 2022

End Date

December 31, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Biocad

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

BCD-201 group

BCD-201 200 mg as a 30-minute intravenous infusion once every 3 weeks

Intervention: BCD-201

Keytruda

Keytruda 200 mg as a 30-minute intravenous infusion once every 3 weeks

Intervention: Keytruda

Outcomes

Primary Outcomes

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

Secondary Outcomes

To compare the disease control rate in the BCD-201 group and the Keytruda group(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(up to 2 years)
To compare the overall survival in the BCD-201 group and the Keytruda group(up to 2 years)
To compare the incidence of Treatment-Emergent Adverse Events (Safety profiles of BCD-201 and Keytruda)(through study completion, an average of 2 years.)
Area under the concentration-time curve (AUC(0-504))(up to 24 weeks of the double-blind treatment period)
AUC(0-∞)(up to 24 weeks of the double-blind treatment period)
Peak Plasma Concentration (Cmax)(up to 24 weeks of the double-blind treatment period)
To compare the ORR according to iRECIST in the BCD-201 group and the Keytruda group(every 12 weeks up to 2 years)
To compare the duration of response in the BCD-201 group and the Keytruda group(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(every 12 weeks up to 2 years)
Time to maximum concentration (Tmax)(up to 24 weeks of the double-blind treatment period)
Elimination rate constant (kel)(up to 24 weeks of the double-blind treatment period)
Total clearance (Cl)(up to 24 weeks of the double-blind treatment period)
Steady-state volume of distribution of the drug substance (Vd)(up to 24 weeks of the double-blind treatment period)
Half-life period (T1/2)(up to 24 weeks of the double-blind treatment period)
Concentrations at the end of each infusion (CEOI)(up to 24 weeks of the double-blind treatment period)
To compare the immunogenicity of BCD-201 and Keytruda.(pre-dose to day169 of the double-blind treatment period, 8 timepoints)