Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of the study BCD-263-1 is to prove the comparability of the pharmacokinetics and similarity of the safety, immunogenicity and pharmacodynamic profiles of BCD-263 and Opdivo following intravenous administration to subjects with advanced unresectable or metastatic melanoma of the skin. The study will have randomized, double-blind design with parallel assignment.
Following screening, subjects will be randomized to receive either BCD-263 or Opdivo in a 1:1 ratio and enter the main study period.
During the main study period, subjects will receive therapy with BCD-263 or Opdivo, which will be administered intravenously until disease progression or signs of unacceptable toxicity develop (whichever occurs earlier).
At Week 25, after completion of all scheduled procedures subjects in both groups will continue to receive open-label BCD-263 for up to a total of 2 years of therapy, or disease progression, or signs of unacceptable toxicity (whichever occurs first).
Following discontinuation of the study therapy, the subjects will enter a follow-up period, during which data on overall survival will be collected through telephone contacts.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BCD-263 | Experimental |
| |
| Opdivo | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BCD-263 | Drug | BCD-263 at a dose 480 mg administered intravenously every 4 weeks up to 6 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC(0-672) of nivolumab | To compare area under the drug concentration-time curve in the time interval from 0 to 672 hours after intravenous administration of BCD-263 and Opdivo | pre-dose to week 25 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | To compare the maximum concentration of nivolumab after intravenous administration of BCD-263 and Opdivo | week 25 |
| AUC(0-∞) | To compare area under the drug concentration-time curve in the time interval from 0 to ∞ after intravenous administration of BCD-263 and Opdivo |
Not provided
Inclusion Criteria:
Age ≥18 years at the time of signing the informed consent form;
Body weight 60 to 90 kg.
Histologically confirmed melanoma with the following prognostic characteristics:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Arina V Zinkina-Orikhan | Director of Clinical Development Department, BIOCAD | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Healthcare Institution "Minsk City Clinical Cancer Center" | Minsk | 220013 | Belarus | |||
| State Institution "Republic Scientific and Practical Centre for Oncology and Medical Radiology Named after N.N.Aleksandrov" |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Opdivo | Drug | Opdivo at a dose 480 mg administered intravenously every 4 weeks up to 6 cycles |
|
|
| week 25 |
| Tmax | To compare time to the maximum concentration of nivolumab after intravenous administration of BCD-263 and Opdivo | week 25 |
| T½ | To compare half-life period of nivolumab after intravenous administration of BCD-263 and Opdivo | week 25 |
| Kel | To compare elimination rate constant of nivolumab after intravenous administration of BCD-263 and Opdivo | week 25 |
| Vd | To compare steady-state volume of distribution of nivolumab after intravenous administration of BCD-263 and Opdivo | week 25 |
| Cl | To compare total clearance of nivolumab after intravenous administration of BCD-263 and Opdivo | week 25 |
| Ceoi | To compare plasma concentration at the and of infusion of nivolumab after intravenous administration of BCD-263 and Opdivo | week 25 |
| Ctrough | To compare trough concentration at the and of infusion of nivolumab after intravenous administration of BCD-263 and Opdivo | week 25 |
| Safety assessment | The subjects will undergo the vital sign assessment, physical and instrumental examination, sampling for complete blood count, blood chemistry, thyroid hormone tests, and urinalysis, as well as assessment of the presence and characteristics of adverse events to assess the safety of the investigational product | week 25 |
| Immunogenicity assessment | Proportion of subjects with binding and/or neutralizing antibodies to nivolumab | week 25 |
| Pharmacodynamics assessment | Occupancy of PD-1 receptors on CD4+ and CD8+ peripheral blood lymphocytes | week 25 |
| Efficacy assessment: ORR | To compare overall response rate according to RECIST 1.1 and iRECIST criteria after administration of BCD-263 or Opdivo | week 25 |
| Efficacy assessment: PFS | To compare progression-free survival according to RECIST 1.1 and iRECIST criteria after administration of BCD-263 or Opdivo | week 25 |
| Efficacy assessment: overall survival | To compare overall survival according to RECIST 1.1 and iRECIST criteria after administration of BCD-263 or Opdivo | week 25 |
| Efficacy assessment: DCR | To compare disease control rate according to RECIST 1.1 and iRECIST criteria after administration of BCD-263 or Opdivo | week 25 |
| Efficacy assessment: time to response | To compare time to response according to RECIST 1.1 and iRECIST criteria after administration of BCD-263 or Opdivo | week 25 |
| Efficacy assessment: duration of response | To compare duration of response according to RECIST 1.1 and iRECIST criteria after administration of BCD-263 or Opdivo | week 25 |
| Minsk |
| 223040 |
| Belarus |
| Chelyabinsk Regional Clinical Center for Oncology and Nuclear Medicine | Chelyabinsk | Chelyabinsk Oblast | 454087 | Russia |
| JSC "Modern Medical Technologies" | Saint Petersburg | Sankt-Peterburg | 190013 | Russia |
| LLC "New Clinic" | Pyatigorsk | Stavropol Kray | 357500 | Russia |
| State Budgetary Institution of Healthcare of the Arkhangelsk Region "Severodvinsk City Hospital №2 of Emergency" | Arkhangelsk | 164523 | Russia |
| Regional State Budgetary Healthcare Institution "Altai Regional Oncological Dispensary" | Barnaul | 656045 | Russia |
| Federal State Educational Institution of Higher Education "Baltic Federal University Named after Immanuel Kant" | Kaliningrad | 236016 | Russia |
| Limited Liability Company "Ars Medica Centre" | Kaliningrad | 236022 | Russia |
| State Budgetary Healthcare Institution of Kaluga Region "Kaluga Region Clinical Oncological Dispensary" | Kaluga | 248007 | Russia |
| State Autonomous Health Institution "Republican Clinical Oncology Dispensary of the Ministry of Health of the Republic of Tatarstan named after Professor M.Z. Sigal" | Kazan' | Russia |
| Regional State Budgetary of Healthcare Insti-tution "Kostroma Clinical Oncology Dispensary" | Kostroma | 156005 | Russia |
| "Russian Cancer Research Center named after N.N. Blokhin "of the Ministry of Health of the Russian Federation | Moscow | 115478 | Russia |
| JSC "Medsi Group" | Moscow | Russia |
| Moscow City Oncology Hospital No. 62 | Moscow | Russia |
| State budgetary health care institution of the city of Moscow "City Clinical Oncology Hospital No. 1 of the Department of Health of the City of Moscow" | Moscow | Russia |
| State Budgetary Healthcare Institution "Moscow Clinical Scientific Center funded by Moscow Health Department" (SBHI MCSC MHD) | Moscow | Russia |
| Nizhny Novgorod Region State Budgetary Healthcare Institution "Nizhny Novgorod Regional Clinical Oncological Dispensary" | Nizhny Novgorod | 603126 | Russia |
| State Budgetary Healthcare Institution of Novosibirsk Region "Novosibirsk Region Clinical Oncological Dispensary" | Novosibirsk | 630108 | Russia |
| State budget healthcare institution Omsk region "Clinical Oncology Dispensary" | Omsk | Russia |
| Private healthcare institution "Clinical hospital "RZD-Medicine" of the city of Saint Petersburg" | Saint Petersburg | 195271 | Russia |
| "Saint Petersburg Clinical Research and Practice Center for Specialized Medical Care (Oncology)" | Saint Petersburg | Russia |
| Federal State Budgetary Institution "N.N. Petrov Research Institute of Oncology" of the Ministry of Healthcare of the Russian Federation | Saint Petersburg | Russia |
| Limited Liability Company "Oncological Research Center" | Saint Petersburg | Russia |
| Private Medical Institution Evromedservis | Saint Petersburg | Russia |
| State-financed Health Institution "Samara Region Clinical Oncology Dispensary" | Samara | 443031 | Russia |
| Federal State Educational Institution of Higher Professional Education "Mordovia State University N.P. Ogareva " | Saransk | Russia |
| Limited Liability Company "Nebbiolo" | Tomsk | 634009 | Russia |
| Republican Clinical Oncology Dispensary of Ministry of Health republic Bashkortostan | Ufa | 450054 | Russia |
| State Health Care Institution "Volgograd Regional Clinical Oncology Dispensary № 1" | Volgograd | Russia |
| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided