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

Melanoma Clinical Trial

Official title:

A Multicenter, Double-Blind, Randomized Clinical Study to Evaluate the Pharmacokinetics and Safety of BCD-201 (JSC BIOCAD, Russia) and Keytruda® in Patients With Different Advanced Malignancies

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05739006
• Other study ID #: BCD-201-1
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: February 8, 2021
• Est. completion date: August 31, 2023

Study information

• Verified date: August 2023
• Source: Biocad
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 131
• Est. completion date: August 31, 2023
• Est. primary completion date: June 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Melanoma
• Non Small Cell Lung Cancer

Intervention

Drug:
• BCD-201
up to 8 treatment cycles
• Keytruda
up to 8 treatment cycles

Locations

Country	Name	City	State
Russian Federation	"Russian Cancer Research Center named after N.N. Blokhin "of the Ministry of Health of the Russian Federation	Moscow
Russian Federation	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

Sponsors (1)

Lead Sponsor	Collaborator
Biocad

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	AUC(0-8) of pembrolizumab	Area under the drug concentration-time curve in the time interval from 0 to 8	pre-dose to week 25, 77 timepoints
Secondary	Cmax	maximum concentration of pembrolizumab	pre-dose to week 25, 77 timepoints
Secondary	Tmax	time to maximum concentration of pembrolizumab	pre-dose to week 25, 77 timepoints
Secondary	T½	Half-life period	pre-dose to week 25, 77 timepoints
Secondary	Vd	Steady-state volume of distribution of the drug substance	pre-dose to week 25, 77 timepoints
Secondary	Cmin	minimum concentration of pembrolizumab	pre-dose to week 25, 77 timepoints
Secondary	kel	Elimination rate constant	pre-dose to week 25, 77 timepoints
Secondary	Cl	Total clearance	pre-dose to week 25, 77 timepoints
Secondary	Safety assessment	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	Day 1 to Day 169
Secondary	Immunogenicity assessment	the frequency of binding and neutralizing anti-pembrolizumab antibody production	pre-dose to week 25, 5 timepoints
Secondary	To compare the results of pilot assessment of BCD-201 and Keytruda efficacy	overall response rate (ORR)	Day 1 to week 25