Clinical trial NCT05986331: Clinical Study of the Efficacy and Safety of BCD-201 and Keytruda in Subjects With Advanced Melanoma
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Melanoma (Skin)
Lead sponsor: Biocad
Sponsor class: INDUSTRY
First posted: 2023-08-14
Enrollment: 366
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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;
* 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.

Primary outcomes:
measure: To compare the overall response rate (ORR) in the BCD-201 group and the Keytruda group
timeFrame: 24 weeks of treatment
Secondary outcomes:
measure: To compare the ORR according to iRECIST in the BCD-201 group and the Keytruda group
timeFrame: every 12 weeks up to 2 years
measure: To compare the duration of response in the BCD-201 group and the Keytruda group
timeFrame: up to 2 years
measure: To compare the time to response according to RECIST 1.1 and iRECIST in the BCD-201 group and the Keytruda group
timeFrame: every 12 weeks up to 2 years
measure: To compare the disease control rate in the BCD-201 group and the Keytruda group
timeFrame: up to 2 years
measure: To compare the progression-free survival (PFS) per RECIST 1.1 and iRECIST in the BCD-201 group and the Keytruda group
timeFrame: up to 2 years
measure: To compare the overall survival in the BCD-201 group and the Keytruda group
timeFrame: up to 2 years
measure: To compare the incidence of Treatment-Emergent Adverse Events (Safety profiles of BCD-201 and Keytruda)
timeFrame: through study completion, an average of 2 years.
measure: Area under the concentration-time curve (AUC(0-504))
timeFrame: up to 24 weeks of the double-blind treatment period
measure: AUC(0-∞)
timeFrame: up to 24 weeks of the double-blind treatment period
measure: Peak Plasma Concentration (Cmax)
timeFrame: up to 24 weeks of the double-blind treatment period
measure: Time to maximum concentration (Tmax)
timeFrame: up to 24 weeks of the double-blind treatment period
measure: Elimination rate constant (kel)
timeFrame: up to 24 weeks of the double-blind treatment period
measure: Total clearance (Cl)
timeFrame: up to 24 weeks of the double-blind treatment period
measure: Steady-state volume of distribution of the drug substance (Vd)
timeFrame: up to 24 weeks of the double-blind treatment period
measure: Half-life period (T1/2)
timeFrame: up to 24 weeks of the double-blind treatment period
measure: Concentrations at the end of each infusion (CEOI)
timeFrame: up to 24 weeks of the double-blind treatment period
measure: To compare the immunogenicity of BCD-201 and Keytruda.
timeFrame: pre-dose to day169 of the double-blind treatment period, 8 timepoints
Other outcomes:
Locations:
city: Omsk
country: Russian Federation
facility: Budgetary healthcare institution of the Omsk region "Clinical oncological dispensary"
city: Saint Petersburg
country: Russian Federation
facility: "Saint Petersburg Clinical Research and Practice Center for Specialized Medical Care (Oncology)"
city: Saint Petersburg
country: Russian Federation
facility: Federal State Budgetary Educational Institution of Higher Education "Saint Petersburg State University"
Study officials:
References: