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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.
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Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
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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 |
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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 |
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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 |
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Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Biocad |
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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 |
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Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
| Overall Status | Recruiting |
| Countries | Belarus, India, Russian Federation |
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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
Recruiting
Address
Healthcare Institution "Bobruisk Interdistrict Oncological Dispensary"
Babruysk, ,
Status
Recruiting
Address
Healthcare Institution "Brest Regional Oncological Dispensary"
Brest, ,
Status
Recruiting
Address
Health Institution "Gomel Regional Clinical Oncology Center"
Gomel, ,
Status
Recruiting
Address
Health care institution "Grodno University Clinic"
Grodno, ,
Status
Recruiting
Address
State Institution "Republican Scientific and Practical Center of Oncology and Medical Radiology named after A.I. N.N. Alexandrov"
Lesnoy, ,
Status
Recruiting
Address
Healthcare Institution "Minsk City Clinical Cancer Center"
Minsk, , 220013
Status
Recruiting
Address
State Institution "Mogilev Regional Oncological Dispensary"
Mogilev, ,
Status
Recruiting
Address
Healthcare Institution "Vitebsk Regional Clinical Oncology Center"
Vitebsk, ,
Status
Recruiting
Address
Fortis Hospital
Faridabad, ,
Status
Recruiting
Address
Kasturba Medical College and Hospital
Mangalore, ,
Status
Recruiting
Address
TATA Memorial Hospital
Mumbai, ,
Status
Recruiting
Address
HealthCare Global Enterprises Ltd, NCHRI Cancer Center
Nagpur, ,
Status
Recruiting
Address
HealthCare Global Enterprises Ltd Manavata cancer Centre
Nashik, ,
Status
Recruiting
Address
Sankalp Superspeciality Hospital
Nashik, ,
Status
Recruiting
Address
All India Institute of Medical Science
New Delhi, ,
Status
Recruiting
Address
Deenanath Mangeshkar Hospital & Research Center
Pune, ,
Status
Recruiting
Address
PDEAS Ayurved Rugnalaya & Steriling Multispeciality Hospital
Pune, ,
Status
Recruiting
Address
Horizon Mulitispeciality Hospital
Sangli, ,
Status
Recruiting
Address
Shalby Hospital
Surat, ,
Status
Recruiting
Address
Kiran Multispeciality hospital &Research
Sūrat, ,
Status
Recruiting
Address
Chelyabinsk Regional Clinical Center for Oncology and Nuclear Medicine
Chelyabinsk, Chelyabinsk Oblast, 454087
Status
Recruiting
Address
LLC "New Clinic"
Pyatigorsk, Stavropol Krai, 357500
Status
Recruiting
Address
Arkhangelsk Clinical Oncology Dispensary
Arkhangel'sk, ,
Status
Recruiting
Address
Regional State Budgetary Institution of Health Care "Altai Regional Oncological Dispensary"
Barnaul, ,
Status
Recruiting
Address
Limited Liability Company "EVIMED"
Chelyabinsk, ,
Status
Recruiting
Address
Private healthcare institution "Clinical hospital "RZD-Medicine" of the city of Chelyabinsk"
Chelyabinsk, ,
Status
Recruiting
Address
State budgetary healthcare institution Leningrad Regional Clinical Hospital
Gatchina, ,
Status
Recruiting
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, ,
Status
Recruiting
Address
State budgetary health care institution "Kuzbass clinical oncological dispensary named after M.S. Rappoport"
Kemerovo, ,
Status
Recruiting
Address
Regional Goverment Budgetary Healthcare State "Kostroma Oncology Center"
Kostroma, , 156005
Status
Recruiting
Address
State Budgetary Institution of Healthcare "Leningrad Regional Clinical Oncological Dispensary named after V.I. L.D. Romana"
Kuz'molovskiy, ,
Status
Recruiting
Address
"Russian Cancer Research Center named after N.N. Blokhin "of the Ministry of Health of the Russian Federation
Moscow, ,
Status
Recruiting
Address
Branch of Hadassah Medical LTD Limited Liability Company
Moscow, ,
Status
Recruiting
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, ,
Status
Recruiting
Address
Joint Stock Company "K31 City"
Moscow, ,
Status
Recruiting
Address
JSC "Medsi Group"
Moscow, ,
Status
Recruiting
Address
Moscow City Oncology Hospital No. 62
Moscow, ,
Status
Recruiting
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, ,
Status
Recruiting
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, ,
Status
Recruiting
Address
Nizhny Novgorod Region State Budgetary Healthcare Facility "Clinical Diagnostics Center"
Nizhny Novgorod, , 603006
Status
Recruiting
Address
LLC "DobroMed"
Novosibirsk, ,
Status
Recruiting
Address
State Budgetary Healthcare Institution "Novosibirsk Regional Clinical Oncology Center" of the Novosibirsk Region
Novosibirsk, ,
Status
Recruiting
Address
Federal State Budgetary Institution "National Medical Research Center for Radiology" of the Ministry of Health of the Russian Federation
Obninsk, ,
Status
Recruiting
Address
Budgetary Healthcare Institution of Omsk Region "Clinical Oncology Center"
Omsk, ,
Status
Recruiting
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, ,
Status
Recruiting
Address
LLC "Clinical Trials"
Saint Petersburg, , 188663
Status
Recruiting
Address
JSC "Modern Medical Technologies"
Saint Petersburg, , 190013
Status
Recruiting
Address
Federal State Budgetary Educational Institution of Higher Education "Saint Petersburg State University"
Saint Petersburg, ,
Status
Recruiting
Address
Federal State Budgetary Health Institution St. Petersburg Clinical Hospital of the Russian Academy of Sciences
Saint Petersburg, ,
Status
Recruiting
Address
Limited Liability Company "EuroCityClinic"
Saint Petersburg, ,
Status
Recruiting
Address
Limited Liability Company "Oncological Research Center"
Saint Petersburg, ,
Status
Recruiting
Address
Limited Liability Company "Stepmed Clinic"
Saint Petersburg, ,
Status
Recruiting
Address
Limited Liability Company "Strategic Medical Systems"
Saint Petersburg, ,
Status
Recruiting
Address
LLC "AV medical group"
Saint Petersburg, ,
Status
Recruiting
Address
N.N. Petrov National Medicine Research Center of oncology
Saint Petersburg, ,
Status
Recruiting
Address
Private Medical Institution Evromedservis
Saint Petersburg, ,
Status
Recruiting
Address
Private institution educational organization of higher education "Medical University "Reaviz"
Samara, ,
Status
Recruiting
Address
State budgetary health care institution "St. Petersburg Clinical Scientific and Practical Center of Specialized Medical Assistance (Oncological)"
Sankt Petersburg, ,
Status
Recruiting
Address
Federal State Educational Institution of Higher Professional Education "Mordovia State University N.P. Ogareva "
Saransk, ,
Status
Recruiting
Address
Oncology Dispensary 2
Sochi, , 354057
Status
Recruiting
Address
City Hospital #40, Kurortny district
St. Petersburg, ,
Status
Recruiting
Address
State Health Care Institution "Volgograd Regional Clinical Oncology Dispensary № 1"
Volgograd, ,
Status
Recruiting
Address
State Regional Budgetary Healthcare Institution "Regional Clinical Oncology Hospital" of the Yaroslavl Region
Yaroslavl, , 150054
