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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05986331
Other study ID # BCD-201-2
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date July 18, 2022
Est. completion date December 31, 2024

Study information

Verified date September 2023
Source Biocad
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 366
Est. completion date December 31, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
BCD-201
up to 8 treatment cycles
Keytruda
up to 8 treatment cycles

Locations

Country Name City State
Russian Federation Budgetary healthcare institution of the Omsk region "Clinical oncological dispensary" Omsk
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" Saint Petersburg

Sponsors (1)

Lead Sponsor Collaborator
Biocad

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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.
Secondary 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
Secondary AUC(0-8) 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
Secondary Peak Plasma Concentration (Cmax) maximum concentration of pembrolizumab up to 24 weeks of the double-blind treatment period
Secondary Time to maximum concentration (Tmax) time to maximum concentration of pembrolizumab up to 24 weeks of the double-blind treatment period
Secondary Elimination rate constant (kel) kel of pembrolizumab up to 24 weeks of the double-blind treatment period
Secondary Total clearance (Cl) Cl of pembrolizumab up to 24 weeks of the double-blind treatment period
Secondary Steady-state volume of distribution of the drug substance (Vd) Vd of pembrolizumab up to 24 weeks of the double-blind treatment period
Secondary Half-life period (T1/2) T1/2 of pembrolizumab up to 24 weeks of the double-blind treatment period
Secondary 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
Secondary 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
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