Main Menu
Main Menu
This website uses cookies that help the website function and that help us understand how you interact with it. Please read our privacy policy for more information.
The aim of study is to investigate the efficacy, safety, immunogenicity, pharmacokinetics, and pharmacodynamics of BCD-217 followed by prolgolimab monotherapy versus prolgolimab monotherapy as first-line therapy in subjects with unresectable or metastatic melanoma.
|
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
|
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
| Eligible Ages | 18 Years and Over |
| Gender | All |
|
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT05732805 |
|
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
|
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Biocad |
|
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
N/A |
| Principal Investigator Affiliation | N/A |
|
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
| Overall Status | Active, not recruiting |
| Countries | Belarus, India, Russia |
|
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Melanoma, Melanoma (Skin), Melanoma Stage III, Melanoma Stage IV, Melanoma Unresectable, Melanoma Metastatic, Melanoma Advanced |
This study is designed as a phase III, randomized, double-blind, placebo-controlled study. After the stratification procedure, subjects are randomized in a 1:1 ratio into 2 groups: - BCD-217 + placebo (4 doses) → prolgolimab (BCD-217 group) - Prolgolimab + placebo (4 doses) → prolgolimab (BCD-100 monotherapy group)
Experimental: BCD-217 (nurulimab + prolgolimab)
BCD-217 followed by prolgolimab 1 mg/kg monotherapy.
Active Comparator: BCD-100 (prolgolimab)
Prolgolimab monotherapy.
Biological: - BCD-217
Subject recieves BCD-217 0.2 mL/kg, which is equivalent to 1 mg/kg nurulimab + 3 mg/kg prolgolimab, as an intravenous infusion once every 3 weeks (Q3W) simultaneously with placebo, a total of 4 intravenous infusions. Beginning with the 5th infusion, subjects are switched to prolgolimab 1 mg/kg monotherapy once every 2 weeks (Q2W).
Biological: - BCD-100
Subject recieves prolgolimab 3 mg/kg as an intravenous infusion once every 3 weeks (Q3W) simultaneously with placebo, a total of 4 intravenous infusions. Beginning with the 5th infusion, subjects are switched to prolgolimab 1 mg/kg monotherapy once every 2 weeks (Q2W).
Biological: - Placebo
Placebo
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Address
Healthcare Institution "Bobruisk Interdistrict Oncological Dispensary"
Babruysk 630468, ,
Status
Address
Healthcare Institution "Brest Regional Oncological Dispensary"
Brest 629634, ,
Status
Address
Health care institution "Grodno University Clinic"
Grodno 628096, ,
Status
Address
Health Institution "Gomel Regional Clinical Oncology Center"
Homyel 627907, ,
Status
Address
State Institution "Republican Scientific and Practical Center of Oncology and Medical Radiology named after A.I. N.N. Alexandrov"
Lesnoy 8148652, ,
Status
Address
Healthcare Institution "Minsk City Clinical Cancer Center"
Minsk 625144, , 220013
Status
Address
State Institution "Mogilev Regional Oncological Dispensary"
Mogilev 625665, ,
Status
Address
Healthcare Institution "Vitebsk Regional Clinical Oncology Center"
Vitebsk 620127, ,
Status
Address
Fortis Hospital
Faridabad 1271951, ,
Status
Address
Kasturba Medical College and Hospital
Mangalore 1263780, ,
Status
Address
TATA Memorial Hospital
Mumbai 1275339, ,
Status
Address
HealthCare Global Enterprises Ltd, NCHRI Cancer Center
Nagpur 1262180, ,
Status
Address
HealthCare Global Enterprises Ltd Manavata cancer Centre
Nashik 1261731, ,
Status
Address
Sankalp Superspeciality Hospital
Nashik 1261731, ,
Status
Address
All India Institute of Medical Science
New Delhi 1261481, ,
Status
Address
Deenanath Mangeshkar Hospital & Research Center
Pune 1259229, ,
Status
Address
PDEAS Ayurved Rugnalaya & Steriling Multispeciality Hospital
Pune 1259229, ,
Status
Address
Horizon Mulitispeciality Hospital
Sangli 1257416, ,
Status
Address
Shalby Hospital
Surat 1255364, ,
Status
Address
Kiran Multispeciality hospital &Research
Sūrat 9984255, ,
Status
Address
Chelyabinsk Regional Clinical Center for Oncology and Nuclear Medicine
Chelyabinsk 1508291, Chelyabinsk Oblast 1508290, 454087
Status
Address
LLC "New Clinic"
Pyatigorsk 503550, Stavropol Kray 487839, 357500
Status
Address
Arkhangelsk Clinical Oncology Dispensary
Arkhangelsk 581049, ,
Status
Address
Regional State Budgetary Institution of Health Care "Altai Regional Oncological Dispensary"
Barnaul 1510853, ,
Status
Address
Limited Liability Company "EVIMED"
Chelyabinsk 1508291, ,
Status
Address
Private healthcare institution "Clinical hospital "RZD-Medicine" of the city of Chelyabinsk"
Chelyabinsk 1508291, ,
Status
Address
State budgetary healthcare institution Leningrad Regional Clinical Hospital
Gatchina 561887, ,
Status
Address
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' 551487, ,
Status
Address
State budgetary health care institution "Kuzbass clinical oncological dispensary named after M.S. Rappoport"
Kemerovo 1503901, ,
Status
Address
Regional Goverment Budgetary Healthcare State "Kostroma Oncology Center"
Kostroma 543878, , 156005
Status
Address
State Budgetary Institution of Healthcare "Leningrad Regional Clinical Oncological Dispensary named after V.I. L.D. Romana"
Kuz'molovskiy 537771, ,
Status
Address
"Russian Cancer Research Center named after N.N. Blokhin "of the Ministry of Health of the Russian Federation
Moscow 524901, ,
Status
Address
Branch of Hadassah Medical LTD Limited Liability Company
Moscow 524901, ,
Status
Address
Federal State Autonomous Educational Institution of Higher Education I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University)
Moscow 524901, ,
Status
Address
Joint Stock Company "K31 City"
Moscow 524901, ,
Status
Address
JSC "Medsi Group"
Moscow 524901, ,
Status
Address
Moscow City Oncology Hospital No. 62
Moscow 524901, ,
Status
Address
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 524901, ,
Status
Address
State Budgetary Institution of Healthcare of the City of Moscow "Moscow Multidisciplinary Clinical Center "Kommunarka" of the Department of Health of the City of Moscow"
Moscow 524901, ,
Status
Address
Nizhny Novgorod Region State Budgetary Healthcare Facility "Clinical Diagnostics Center"
Nizhny Novgorod 520555, , 603006
Status
Address
LLC "DobroMed"
Novosibirsk 1496747, ,
Status
Address
State Budgetary Healthcare Institution "Novosibirsk Regional Clinical Oncology Center" of the Novosibirsk Region
Novosibirsk 1496747, ,
Status
Address
Federal State Budgetary Institution "National Medical Research Center for Radiology" of the Ministry of Health of the Russian Federation
Obninsk 516436, ,
Status
Address
Budgetary Healthcare Institution of Omsk Region "Clinical Oncology Center"
Omsk 1496153, ,
Status
Address
Federal State Budgetary Institution "National Medical Research Center of Oncology named after N.N. Petrov" of the Ministry of Health of the Russian Federation (FSBI "N.N. Petrov National Medical Research Center of Oncology" of the Ministry of Health of Ru
Pesochnyy 510410, ,
Status
Address
LLC "Clinical Trials"
Saint Petersburg 498817, , 188663
Status
Address
JSC "Modern Medical Technologies"
Saint Petersburg 498817, , 190013
Status
Address
City Hospital #40, Kurortny district
Saint Petersburg 498817, ,
Status
Address
Federal State Budgetary Educational Institution of Higher Education "Saint Petersburg State University"
Saint Petersburg 498817, ,
Status
Address
Federal State Budgetary Health Institution St. Petersburg Clinical Hospital of the Russian Academy of Sciences
Saint Petersburg 498817, ,
Status
Address
Limited Liability Company "EuroCityClinic"
Saint Petersburg 498817, ,
Status
Address
Limited Liability Company "Oncological Research Center"
Saint Petersburg 498817, ,
Status
Address
Limited Liability Company "Stepmed Clinic"
Saint Petersburg 498817, ,
Status
Address
Limited Liability Company "Strategic Medical Systems"
Saint Petersburg 498817, ,
Status
Address
LLC "AV medical group"
Saint Petersburg 498817, ,
Status
Address
N.N. Petrov National Medicine Research Center of oncology
Saint Petersburg 498817, ,
Status
Address
Private Medical Institution Evromedservis
Saint Petersburg 498817, ,
Status
Address
State budgetary health care institution "St. Petersburg Clinical Scientific and Practical Center of Specialized Medical Assistance (Oncological)"
Saint Petersburg 498817, ,
Status
Address
Private institution educational organization of higher education "Medical University "Reaviz"
Samara 499099, ,
Status
Address
Federal State Educational Institution of Higher Professional Education "Mordovia State University N.P. Ogareva "
Saransk 498698, ,
Status
Address
Oncology Dispensary 2
Sochi 491422, , 354057
Status
Address
State Health Care Institution "Volgograd Regional Clinical Oncology Dispensary № 1"
Volgograd 472757, ,
Status
Address
State Regional Budgetary Healthcare Institution "Regional Clinical Oncology Hospital" of the Yaroslavl Region
Yaroslavl 468902, , 150054
