History of Changes for Study: NCT05739006

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

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Study Record Versions

Version	A	B	Submitted Date	Changes
1			February 13, 2023	None (earliest Version on record)
2			August 1, 2023	Study Status and Study Identification

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	BCD-201-1
Brief Title:	Double-Blind, Randomized Clinical Trial to Evaluate the PK and Safety of BCD-201 and Keytruda® in Patients With Advanced Malignancies
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
Secondary IDs:

Study Status


Record Verification:	February 2023
Overall Status:	Active, not recruiting
Study Start:	February 8, 2021
Primary Completion:	June 21, 2022 [Actual]
Study Completion:	August 31, 2023 [Anticipated]

First Submitted:	February 13, 2023
First Submitted that Met QC Criteria:	February 13, 2023
First Posted:	February 22, 2023 [Actual]

Last Update Submitted that Met QC Criteria:	February 13, 2023
Last Update Posted:	February 22, 2023 [Actual]

Sponsor/Collaborators


Sponsor:	Biocad
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:	No
U.S. FDA-regulated Device:	No
Data Monitoring:	No

Study Description

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:

Conditions


Conditions:	Melanoma Non Small Cell Lung Cancer
Keywords:

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 1
Interventional Study Model:	Parallel Assignment
Number of Arms:	2
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:	Randomized
Enrollment:	131 [Actual]

Arms and Interventions

Arms	Assigned Interventions
Experimental: Group 1 BCD-201 200 mg by intravenous infusions once every 3 weeks	Drug: BCD-201 up to 8 treatment cycles Other Names: pembrolizumab
Active Comparator: Group 2 Keytruda 200 mg by intravenous infusions once every 3 weeks	Drug: Keytruda up to 8 treatment cycles Other Names: pembrolizumab

Outcome Measures


Primary Outcome Measures:
1.	AUC(0-504) of pembrolizumab [ Time Frame: 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:
1.	AUC(0-∞) of pembrolizumab [ Time Frame: pre-dose to week 25, 77 timepoints ] Area under the drug concentration-time curve in the time interval from 0 to ∞
2.	Cmax [ Time Frame: pre-dose to week 25, 77 timepoints ] maximum concentration of pembrolizumab
3.	Tmax [ Time Frame: pre-dose to week 25, 77 timepoints ] time to maximum concentration of pembrolizumab
4.	T½ [ Time Frame: pre-dose to week 25, 77 timepoints ] Half-life period
5.	Vd [ Time Frame: pre-dose to week 25, 77 timepoints ] Steady-state volume of distribution of the drug substance
6.	Cmin [ Time Frame: pre-dose to week 25, 77 timepoints ] minimum concentration of pembrolizumab
7.	kel [ Time Frame: pre-dose to week 25, 77 timepoints ] Elimination rate constant
8.	Cl [ Time Frame: pre-dose to week 25, 77 timepoints ] Total clearance
9.	Safety assessment [ Time Frame: 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
10.	Immunogenicity assessment [ Time Frame: pre-dose to week 25, 5 timepoints ] the frequency of binding and neutralizing anti-pembrolizumab antibody production
11.	To compare the results of pilot assessment of BCD-201 and Keytruda efficacy [ Time Frame: Day 1 to week 25 ] overall response rate (ORR)

Eligibility


Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	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.

Contacts/Locations


Locations:	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, Russian Federation, 197758

IPDSharing


Plan to Share IPD:	No

References


Citations:
Links:
Available IPD/Information: