Clinical Study of the Efficacy and Safety of BCD-201 and Keytruda in Subjects With Advanced Melanoma
- Registration Number
- NCT05986331
- Lead Sponsor
- Biocad
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 366
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BCD-201 group BCD-201 BCD-201 200 mg as a 30-minute intravenous infusion once every 3 weeks Keytruda Keytruda Keytruda 200 mg as a 30-minute intravenous infusion once every 3 weeks
- Primary Outcome Measures
Name Time Method To compare the overall response rate (ORR) in the BCD-201 group and the Keytruda group 24 weeks of treatment ORR according to RECIST 1.1
- Secondary Outcome Measures
Name Time Method To compare the disease control rate in the BCD-201 group and the Keytruda group up to 2 years The percentage of the participants who have a Complete Response, a Partial Response or a Stable DIsease
To compare the progression-free survival (PFS) per RECIST 1.1 and iRECIST in the BCD-201 group and the Keytruda group up to 2 years The time from the date of randomization until progression of disease according to RECIST 1.1 / iRECIST criteria or death
To compare the overall survival in the BCD-201 group and the Keytruda group up to 2 years The time from the date of randomization until death
To compare the incidence of Treatment-Emergent Adverse Events (Safety profiles of BCD-201 and Keytruda) through study completion, an average of 2 years. 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
Area under the concentration-time curve (AUC(0-504)) up to 24 weeks of the double-blind treatment period Area under the plasma concentration versus time curve in the time interval from 0 to 504 hours
AUC(0-∞) up to 24 weeks of the double-blind treatment period Area under the plasma concentration versus time curve in the time interval from 0 to time infinity
Peak Plasma Concentration (Cmax) up to 24 weeks of the double-blind treatment period maximum concentration of pembrolizumab
To compare the ORR according to iRECIST in the BCD-201 group and the Keytruda group every 12 weeks up to 2 years ORR according to iRECIST
Total clearance (Cl) up to 24 weeks of the double-blind treatment period Cl of pembrolizumab
Steady-state volume of distribution of the drug substance (Vd) up to 24 weeks of the double-blind treatment period Vd of pembrolizumab
To compare the duration of response in the BCD-201 group and the Keytruda group up to 2 years Duration of response will be calculated from the moment of registration of response till event (progression or death)
To compare the time to response according to RECIST 1.1 and iRECIST in the BCD-201 group and the Keytruda group every 12 weeks up to 2 years time to response will be calculated from the randomization date
Time to maximum concentration (Tmax) up to 24 weeks of the double-blind treatment period time to maximum concentration of pembrolizumab
Elimination rate constant (kel) up to 24 weeks of the double-blind treatment period kel of pembrolizumab
Half-life period (T1/2) up to 24 weeks of the double-blind treatment period T1/2 of pembrolizumab
Concentrations at the end of each infusion (CEOI) up to 24 weeks of the double-blind treatment period concentrations at the end of each infusion of pembrolizumab
To compare the immunogenicity of BCD-201 and Keytruda. pre-dose to day169 of the double-blind treatment period, 8 timepoints Development of binding and neutralizing antibodies to pembrolizumab
Trial Locations
- Locations (3)
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, Russian Federation