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

NCT ID: NCT05986331

Last Updated: 2023-09-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 366 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-18
• Study Completion Date: 2024-12-31

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.

Conditions

Melanoma (Skin)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

BCD-201 group

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

Group Type: EXPERIMENTAL

BCD-201

Intervention Type: DRUG

up to 8 treatment cycles

Keytruda

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

Group Type: ACTIVE_COMPARATOR

Keytruda

Intervention Type: DRUG

up to 8 treatment cycles

Interventions

BCD-201

up to 8 treatment cycles

Intervention Type: DRUG

Keytruda

up to 8 treatment cycles

Intervention Type: DRUG

Other Intervention Names

Pembrolizumab; pembrolizumab

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biocad

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

Russia

Other Identifiers

BCD-201-2

Identifier Type: -

Identifier Source: org_study_id