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

Biocad366 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

366

Conditions

Melanoma (Skin)

Interventions

BCD-201DRUG

up to 8 treatment cycles

KeytrudaDRUG

up to 8 treatment cycles

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (3)

Budgetary healthcare institution of the Omsk region "Clinical oncological dispensary"

Omsk, Russia

"Saint Petersburg Clinical Research and Practice Center for Specialized Medical Care (Oncology)"

Saint Petersburg, Russia

Federal State Budgetary Educational Institution of Higher Education "Saint Petersburg State University"

Saint Petersburg, Russia

Outcomes

Primary Outcomes

To compare the overall response rate (ORR) in the BCD-201 group and the Keytruda group

ORR according to RECIST 1.1

Time frame: 24 weeks of treatment

Secondary Outcomes

To compare the ORR according to iRECIST in the BCD-201 group and the Keytruda group

ORR according to iRECIST

Time frame: 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)

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.