Melanoma (Skin)
Conditions
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.
Sponsors
Biocad
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Peak Plasma Concentration (Cmax) | up to 24 weeks of the double-blind treatment period | maximum concentration of pembrolizumab |
Countries
Russia
Outcome results
None listed