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

Melanoma (Skin) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05986331
• Other study ID #: BCD-201-2
• Status: Active, not recruiting
• Phase: Phase 3
• 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
• 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.

Related Conditions & MeSH terms

• Melanoma
• Melanoma (Skin)

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