Clinical Trial to Evaluate the PK and Safety of BCD-201 and Keytruda® in Patients With Advanced Malignancies

NCT05739006 | Unknown Phase 1

• 1 other identifier: BCD-201-1
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 3

Brief Summary

Clinical study BCD-201-1 is a double-blind randomized study of the pharmacokinetics (PK), pharmacodynamics (PD), safety, and immunogenicity of BCD-201 versus Keytruda following intravenous administration to subjects with advanced unresectable, metastatic, or recurrent melanoma and NSCLC. The study aimed to establish the equivalence of PK and similarity of the safety, immunogenicity, and PD profiles of BCD-201 and Keytruda.

Conditions

Melanoma; Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• AUC(0-504) of pembrolizumab

  area under the drug concentration-time curve in the time interval from 0 to 504 hours

  pre-dose to week 25, 77 timepoints

Secondary Outcomes (11)

• AUC(0-∞) of pembrolizumab

  pre-dose to week 25, 77 timepoints

• Cmax

  pre-dose to week 25, 77 timepoints

• Tmax

  pre-dose to week 25, 77 timepoints

• T½

  pre-dose to week 25, 77 timepoints

• Vd

  pre-dose to week 25, 77 timepoints

Study Arms (2)

Group 1

EXPERIMENTAL

BCD-201 200 mg by intravenous infusions once every 3 weeks

Drug: BCD-201

Group 2

ACTIVE COMPARATOR

Keytruda 200 mg by intravenous infusions once every 3 weeks

Drug: Keytruda

Interventions

BCD-201 DRUG

up to 8 treatment cycles

Also known as: pembrolizumab

Group 1

Keytruda DRUG

up to 8 treatment cycles

Also known as: pembrolizumab

Group 2

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;
• Body weight 60 to 90 kg;
• Histologically confirmed melanoma or NSCLC (patients with NSCLC are eligible to participate if high tumor PD-L1 expression \[≥50%\] is confirmed by local or central laboratory results);
• ECOG score 0-1;
• Laboratory test results consistent with adequate functioning of systems and organs;
• Willingness of males and females of childbearing potential to use highly effective contraceptive methods from the signing of the informed consent form, throughout the study and within 6 months after the administration of the last product dose

You may not qualify if:

• Indications for radical therapy (surgery, radiation therapy);
• Previous systemic anti-tumor therapy for advanced unresectable, recurrent or metastatic melanoma or NSCLC (history of neoadjuvant or adjuvant therapy is acceptable provided that the treatment was completed at least 6 weeks prior to randomization);
• Active metastases in the central nervous system and/or carcinomatous meningitis;
• Patients with severe concomitant disorders, life-threatening acute complications of the primary disease (including massive pleural, pericardial, or peritoneal effusions requiring intervention, pulmonary lymphangitis, bleeding or organ perforation) at the time of signing the informed consent and during the screening period;
• For patients with NSCLC: presence of activating EGFR mutations/ALK translocations;
• 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)

"Russian Cancer Research Center named after N.N. Blokhin "of the Ministry of Health of the Russian Federation

Moscow, Russia

Location

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

Omsk, Russia

Location

State Budgetary Healthcare Institution "Saint Petersburg Clinical Research and Practice Center for Specialized Medical Care (Oncology)"

Saint Petersburg, 197758, Russia

Location

MeSH Terms

Conditions

Melanoma; Carcinoma, Non-Small-Cell Lung

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; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• 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: February 22, 2023
• Study Start: February 8, 2021
• Primary Completion: June 21, 2022
• Study Completion: August 31, 2023
• Last Updated: August 2, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

RU (3)