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

NCT05986331 | Unknown Phase 3

• 1 other identifier: BCD-201-2
• Study Type: interventional
• Target: 366
• Locations: 1 country
• Sites: 3

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)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• 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

• 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

Study Arms (2)

BCD-201 group

EXPERIMENTAL

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

Drug: BCD-201

Keytruda

ACTIVE COMPARATOR

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

Drug: Keytruda

Interventions

BCD-201 DRUG

up to 8 treatment cycles

Also known as: Pembrolizumab

BCD-201 group

Keytruda DRUG

up to 8 treatment cycles

Also known as: pembrolizumab

Keytruda

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biocad: lead

Study Sites (3)

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

Omsk, Russia

Location

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

Saint Petersburg, Russia

Location

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

Saint Petersburg, Russia

Location

MeSH Terms

Conditions

Melanoma

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: August 14, 2023
• Study Start: July 18, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

RU (3)