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