A clinical study to see to efficacy and safety of bcd-201 (Pembrolizumab) and Keytruda® for treatment in patients with unresolvable or evolved skin cancer.

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/12/048496

Enrollment

366

Registered

2022-12-26

Start date

Unknown

Completion date

Unknown

Last updated

2023-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C439- Malignant melanoma of skin, unspecified

Interventions

Intervention1: Pembrolizumab (JSC BIOCAD, Russia), concentrate for solution for infusion, 25 mg/mL: administered intravenously at a dose of 200 mg once every 3 weeks for 24 weeks or until disease prog

Eligibility

Inclusion criteria

Inclusion criteria: Age =18 years at the signing of the informed consent form. 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. At least one measurable lesion according to RECIST 1.1 based on central review. ECOG score 0–1.

Exclusion criteria

Exclusion criteria: Indications for radical therapy (surgery, radiation therapy). Uveal melanoma or mucosal melanoma. Previous systemic anti-tumor therapy for advanced unresectable, recurrent or metastatic skin melanoma (history of neoadjuvant or adjuvant therapy is acceptable provided that the treatment was completed at least 6 weeks prior to randomization). Active CNS metastases and/or carcinomatous meningitis. Subjects with brain metastases are eligible to participate provided that the metastases have been adequately treated with surgery or radiation therapy only and are stable based on the results of imaging assessments. Previous invasive malignancy with any evidence of the disease within the last 3 years. Participants with non-melanoma skin cancer or carcinoma in situ (e.g., breast cancer) who have undergone radical therapy are not excluded.

Design outcomes

Primary

Measure	Time frame
To compare the overall response rate (ORR) in the BCD-201 group and the Keytruda group.Timepoint: week 1 to week 25	—

Secondary

Measure	Time frame
To compare the secondary efficacy endpoints, safety profiles, pharmacokinetics, immunogenicity of BCD-201 and KeytrudaTimepoint: week 1 to week 25	—

Countries

Belarus, India, Russian Federation

Contacts

Public ContactDr Devesh Kumar

IR Innovate Research Pvt Ltd

devesh.kumar@innovate-research.com7827758840

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026