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

Phase 1

Active, not recruiting

• Conditions: Melanoma; Non Small Cell Lung Cancer
• Interventions: Drug: BCD-201; Drug: Keytruda

• Registration Number: NCT05739006
• Lead Sponsor: Biocad

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-08
• Primary Completion: 2022-06-21
• Study First Submitted: 2023-02-13
• Study First Submitted QC: 2023-02-13
• Study First Posted: 2023-02-22
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-01
• Last Update Posted: 2023-08-02
• Study Completion: 2023-08-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 131

Inclusion Criteria

• 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

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Exclusion Criteria

• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	BCD-201	BCD-201 200 mg by intravenous infusions once every 3 weeks
Group 2	Keytruda	Keytruda 200 mg by intravenous infusions once every 3 weeks

Primary Outcome Measures

Name	Time	Method
AUC(0-504) of pembrolizumab	pre-dose to week 25, 77 timepoints	area under the drug concentration-time curve in the time interval from 0 to 504 hours

Secondary Outcome Measures

Name	Time	Method
Cmax	pre-dose to week 25, 77 timepoints	maximum concentration of pembrolizumab
kel	pre-dose to week 25, 77 timepoints	Elimination rate constant
Cl	pre-dose to week 25, 77 timepoints	Total clearance
Safety assessment	Day 1 to Day 169	proportion of patients with any adverse events (AEs); • proportion of patients with severe AEs; proportion of patients who discontinued study therapy due to AEs; • proportion of patients with immune-mediated AEs
Tmax	pre-dose to week 25, 77 timepoints	time to maximum concentration of pembrolizumab
Cmin	pre-dose to week 25, 77 timepoints	minimum concentration of pembrolizumab
AUC(0-∞) of pembrolizumab	pre-dose to week 25, 77 timepoints	Area under the drug concentration-time curve in the time interval from 0 to ∞
Vd	pre-dose to week 25, 77 timepoints	Steady-state volume of distribution of the drug substance
T½	pre-dose to week 25, 77 timepoints	Half-life period
Immunogenicity assessment	pre-dose to week 25, 5 timepoints	the frequency of binding and neutralizing anti-pembrolizumab antibody production
To compare the results of pilot assessment of BCD-201 and Keytruda efficacy	Day 1 to week 25	overall response rate (ORR)

Trial Locations

Locations (3)

Budgetary healthcare institution of the Omsk region "Clinical oncological dispensary"; 🇷🇺 Omsk, Russian Federation

State Budgetary Healthcare Institution "Saint Petersburg Clinical Research and Practice Center for Specialized Medical Care (Oncology)"; 🇷🇺 Saint Petersburg, Russian Federation

"Russian Cancer Research Center named after N.N. Blokhin "of the Ministry of Health of the Russian Federation; 🇷🇺 Moscow, Russian Federation