Clinical Study of the Efficacy and Safety of BCD-201 and Keytruda in Subjects With Advanced Melanoma
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: BCD-201 group BCD-201 200 mg as a 30-minute intravenous infusion once every 3 weeks |
Drug: BCD-201
up to 8 treatment cycles
Other Names:
|
| Active Comparator: Keytruda Keytruda 200 mg as a 30-minute intravenous infusion once every 3 weeks |
Drug: Keytruda
up to 8 treatment cycles
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
- 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
- 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
- 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
- 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
- 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
Eligibility Criteria
Criteria
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;
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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 and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Budgetary healthcare institution of the Omsk region "Clinical oncological dispensary" | Omsk | Russian Federation | ||
| 2 | "Saint Petersburg Clinical Research and Practice Center for Specialized Medical Care (Oncology)" | Saint Petersburg | Russian Federation | ||
| 3 | Federal State Budgetary Educational Institution of Higher Education "Saint Petersburg State University" | Saint Petersburg | Russian Federation |
Sponsors and Collaborators
- Biocad
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BCD-201-2