Melanoma (Skin) Clinical Trial
Official title:
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
Verified date | September 2023 |
Source | Biocad |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This clinical study is designed as a randomized, double-blind trial. Subjects with unresectable, metastatic, or recurrent skin melanoma will be randomized to one of the two study groups (BCD-201 group and Keytruda group) at a 1:1 ratio. The goal of this study is to compare the efficacy and safety of BCD-201 and Keytruda as first-line therapy in subjects with unresectable, metastatic, or recurrent skin melanoma.
Status | Active, not recruiting |
Enrollment | 366 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Signed informed consent; - 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; - ECOG score 0-1; - At least one measurable lesion according to RECIST 1.1; - Laboratory test results consistent with adequate functioning of systems and organs; - Willingness of men and women of childbearing potential to use highly effective contraceptive methods from the signing of the informed consent form, throughout the study and for 6 months after the administration of the last product dose. Exclusion Criteria: - Indications for radical therapy (surgery, radiation therapy); - Uveal, ocular or mucosal melanoma; - Active CNS metastases and/or carcinomatous meningitis; - Subjects with severe concomitant disorders, life-threatening acute complications of the primary disease; - 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. |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Budgetary healthcare institution of the Omsk region "Clinical oncological dispensary" | Omsk | |
Russian Federation | "Saint Petersburg Clinical Research and Practice Center for Specialized Medical Care (Oncology)" | Saint Petersburg | |
Russian Federation | Federal State Budgetary Educational Institution of Higher Education "Saint Petersburg State University" | Saint Petersburg |
Lead Sponsor | Collaborator |
---|---|
Biocad |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To compare the overall response rate (ORR) in the BCD-201 group and the Keytruda group | ORR according to RECIST 1.1 | 24 weeks of treatment | |
Secondary | To compare the ORR according to iRECIST in the BCD-201 group and the Keytruda group | ORR according to iRECIST | every 12 weeks up to 2 years | |
Secondary | To compare the duration of response in the BCD-201 group and the Keytruda group | Duration of response will be calculated from the moment of registration of response till event (progression or death) | up to 2 years | |
Secondary | To compare the time to response according to RECIST 1.1 and iRECIST in the BCD-201 group and the Keytruda group | time to response will be calculated from the randomization date | every 12 weeks up to 2 years | |
Secondary | To compare the disease control rate in the BCD-201 group and the Keytruda group | The percentage of the participants who have a Complete Response, a Partial Response or a Stable DIsease | up to 2 years | |
Secondary | To compare the progression-free survival (PFS) per RECIST 1.1 and iRECIST in the BCD-201 group and the Keytruda group | The time from the date of randomization until progression of disease according to RECIST 1.1 / iRECIST criteria or death | up to 2 years | |
Secondary | To compare the overall survival in the BCD-201 group and the Keytruda group | The time from the date of randomization until death | up to 2 years | |
Secondary | To compare the incidence of Treatment-Emergent Adverse Events (Safety profiles of BCD-201 and Keytruda) | Presence of any adverse events (AEs), presence of adverse reactions (ARs), presence of serious adverse reactions (SARs), presence of severe ARs (grade 3 or higher severity according to CTCAE v.5.0), presence of ARs leading to discontinuation of study therapy, presence of immune-mediated AEs | through study completion, an average of 2 years. | |
Secondary | Area under the concentration-time curve (AUC(0-504)) | Area under the plasma concentration versus time curve in the time interval from 0 to 504 hours | up to 24 weeks of the double-blind treatment period | |
Secondary | AUC(0-8) | Area under the plasma concentration versus time curve in the time interval from 0 to time infinity | up to 24 weeks of the double-blind treatment period | |
Secondary | Peak Plasma Concentration (Cmax) | maximum concentration of pembrolizumab | up to 24 weeks of the double-blind treatment period | |
Secondary | Time to maximum concentration (Tmax) | time to maximum concentration of pembrolizumab | up to 24 weeks of the double-blind treatment period | |
Secondary | Elimination rate constant (kel) | kel of pembrolizumab | up to 24 weeks of the double-blind treatment period | |
Secondary | Total clearance (Cl) | Cl of pembrolizumab | up to 24 weeks of the double-blind treatment period | |
Secondary | Steady-state volume of distribution of the drug substance (Vd) | Vd of pembrolizumab | up to 24 weeks of the double-blind treatment period | |
Secondary | Half-life period (T1/2) | T1/2 of pembrolizumab | up to 24 weeks of the double-blind treatment period | |
Secondary | Concentrations at the end of each infusion (CEOI) | concentrations at the end of each infusion of pembrolizumab | up to 24 weeks of the double-blind treatment period | |
Secondary | To compare the immunogenicity of BCD-201 and Keytruda. | Development of binding and neutralizing antibodies to pembrolizumab | pre-dose to day169 of the double-blind treatment period, 8 timepoints |
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