protocolSection identificationModule nctId: NCT06320353, orgStudyIdInfo id: CL01860211, briefTitle: Study сomparing the Efficacy and Safety of RPH-075 and Keytruda® in Patients With Unresectable or Metastatic Skin Melanoma, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-09-27, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2026-01, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: R-Pharm, class: INDUSTRY, collaborators name: Data Management 365, collaborators name: Exacte Labs LLC, collaborators name: Federal State Budgetary Institution of the Central Research Institute of Epidemiology of Rospotrebnadzor, descriptionModule briefSummary: The goal of this double-blind, randomized study is to establish the equivalence of the efficacy, safety and immunogenicity of the drugs RPH-075 (international nonproprietary name (INN) is pembrolizumab) and Keytruda® (INN is pembrolizumab) when used in patients with unresectable or metastatic skin melanoma first or second line therapy in a monotherapy regimen.The main task is to evaluate and compare the effectiveness of RPH-075 and Keytruda® drugs when used in patients with unresectable or metastatic skin melanoma as a 1 or 2 line therapy in monotherapy regimen, according to the objective response rate (ORR) parameter for up to 24 weeks of therapy., conditionsModule conditions: Skin Melanoma, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 266, type: ACTUAL, armsInterventionsModule interventions name: RPH-075, interventions name: Keytruda®, outcomesModule primaryOutcomes measure: The objective response rate (ORR), secondaryOutcomes measure: The disease control rate (DCR), secondaryOutcomes measure: The time to response (TTR), secondaryOutcomes measure: The Duration of response (DOR), secondaryOutcomes measure: The Progression-free survival (PFS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Federal State Budgetary Institution "National Medical Research Center of Radiology" of the Ministry of Health of the Russian Federation, city: Obninsk, state: Kaluga Region, zip: 249036, country: Russian Federation, geoPoint lat: 55.09681, lon: 36.61006, locations facility: State Budgetary Healthcare Institution "Clinical Oncological Dispensary No. 1" of the Ministry of Health of the Krasnodar Territory, city: Krasnodar, state: Krasnodar Territory, zip: 350040, country: Russian Federation, geoPoint lat: 45.04484, lon: 38.97603, locations facility: Regional Budgetary Healthcare Institution "Kursk Oncological Research and Clinical Center named after G.E. Ostroverkhov", city: Kislino, state: Kursk Region, zip: 305524, country: Russian Federation, locations facility: State Budgetary Healthcare Institution of the city of Moscow "Moscow City Oncological Hospital No. 62 of the Department of Health of the City of Moscow", city: Istra, state: Moscow Region, zip: 143515, country: Russian Federation, geoPoint lat: 55.91997, lon: 36.86867, locations facility: The State budgetary healthcare Institution of the Stavropol Territory "Pyatigorsk Interdistrict Oncological Dispensary", city: Pyatigorsk, state: Stavropol Territory, zip: 357502, country: Russian Federation, geoPoint lat: 44.04861, lon: 43.05944, locations facility: The State Autonomous Healthcare Institution of the Sverdlovsk region "Sverdlovsk Regional Oncological Dispensary", city: Ekaterinburg, state: Sverdlovsk Region, zip: 620036, country: Russian Federation, geoPoint lat: 56.8519, lon: 60.6122, locations facility: State Autonomous Healthcare Institution Republican Clinical Oncological Dispensary of the Ministry of Health of the Republic of Bashkortostan, city: Ufa, state: The Republic Of Bashkortostan, zip: 450054, country: Russian Federation, geoPoint lat: 54.74306, lon: 55.96779, locations facility: State Autonomous Healthcare Institution "Republican Clinical Oncological Dispensary of the Ministry of Health of the Republic of Tatarstan named after Professor M.Z.Segal", city: Kazan, state: The Republic Of Tatarstan, zip: 420029, country: Russian Federation, geoPoint lat: 55.78874, lon: 49.12214, locations facility: Budgetary Healthcare Institution of the Udmurt Republic "Sergey Grigoryevich Primushko Republican Clinical Oncological Dispensary of the Ministry of Health of the Udmurt Republic", city: Izhevsk, state: Udmurt Republic, zip: 426009, country: Russian Federation, geoPoint lat: 56.84976, lon: 53.20448, locations facility: State Budgetary Healthcare Institution of the Arkhangelsk region "Arkhangelsk Clinical Oncological Dispensary", city: Arkhangelsk, zip: 163045, country: Russian Federation, geoPoint lat: 64.5401, lon: 40.5433, locations facility: State Budgetary Healthcare Institution "Regional Oncological Dispensary", city: Irkutsk, zip: 664035, country: Russian Federation, geoPoint lat: 52.29778, lon: 104.29639, locations facility: Regional budgetary healthcare institution "Ivanovo Regional Oncological Dispensary", city: Ivanovo, zip: 153040, country: Russian Federation, geoPoint lat: 56.99719, lon: 40.97139, locations facility: Kaluga Region State Budgetary Healthcare Institution "Kaluga Regional Clinical Oncological Dispensary", city: Kaluga, zip: 248007, country: Russian Federation, geoPoint lat: 54.5293, lon: 36.27542, locations facility: State Budgetary healthcare Institution "Kuzbass Clinical Oncological Dispensary named after M.S. Rappoport", city: Kemerovo, zip: 650036, country: Russian Federation, geoPoint lat: 55.33333, lon: 86.08333, locations facility: Regional State Budgetary Healthcare Institution "Krasnoyarsk Regional Clinical Oncological Dispensary named after A.I. Kryzhanovsky", city: Krasnoyarsk, zip: 660133, country: Russian Federation, geoPoint lat: 56.01839, lon: 92.86717, locations facility: State Budgetary Institution of healthcare of the city of Moscow "Moscow Multidisciplinary Clinical Center "Kommunarka" of the Department of Healthcare of the City of Moscow", city: Moscow, zip: 108814, country: Russian Federation, geoPoint lat: 55.75222, lon: 37.61556, locations facility: Federal State Budgetary Institution "N.N. Blokhin National Medical Research Center of Oncology" of the Ministry of Health of the Russian Federation, city: Moscow, zip: 115478, country: Russian Federation, geoPoint lat: 55.75222, lon: 37.61556, locations facility: State Budgetary Healthcare Institution of the city of Moscow "City Clinical Oncological Hospital No. 1 of the Department of Health of the City of Moscow", city: Moscow, zip: 117152, country: Russian Federation, geoPoint lat: 55.75222, lon: 37.61556, locations facility: Federal State Autonomous Education Insitution of High Education the First Moscow State Medical University named after I.M. Sechenov of Ministry of Healthcare of Russian Federation (Sechenov University), city: Moscow, zip: 119991, country: Russian Federation, geoPoint lat: 55.75222, lon: 37.61556, locations facility: Branch Office of "Hadassah Medical Ltd", city: Moscow, zip: 121205, country: Russian Federation, geoPoint lat: 55.75222, lon: 37.61556, locations facility: "Moscow Center for Rehabilitation Treatment" LLC, city: Moscow, zip: 121552, country: Russian Federation, geoPoint lat: 55.75222, lon: 37.61556, locations facility: Medsi Group of Companies JSC, city: Moscow, zip: 123056, country: Russian Federation, geoPoint lat: 55.75222, lon: 37.61556, locations facility: "Research lab" LLC, city: Moscow, zip: 127521, country: Russian Federation, geoPoint lat: 55.75222, lon: 37.61556, locations facility: State Budgetary Healthcare Institution of the Nizhny Novgorod region "Nizhny Novgorod Regional Clinical Oncological Dispensary", city: Nizhny Novgorod, zip: 603126, country: Russian Federation, geoPoint lat: 56.32867, lon: 44.00205, locations facility: State Budgetary Healthcare Institution of the Novosibirsk region "Novosibirsk Regional Clinical Oncological Dispensary", city: Novosibirsk, zip: 630108, country: Russian Federation, geoPoint lat: 55.0415, lon: 82.9346, locations facility: Budgetary healthcare institution of the Omsk region "Clinical Oncological Dispensary", city: Omsk, zip: 644013, country: Russian Federation, geoPoint lat: 54.99244, lon: 73.36859, locations facility: State Budgetary Healthcare Institution of the Perm Territory "Perm Regional Oncological Dispensary", city: Perm, zip: 614066, country: Russian Federation, geoPoint lat: 58.01046, lon: 56.25017, locations facility: State Budgetary Healthcare Institution Leningrad Regional Clinical Hospital, city: Saint Petersburg, zip: 188300, country: Russian Federation, geoPoint lat: 59.93863, lon: 30.31413, locations facility: Private healthcare institution "Clinical Hospital "Russian Railways-Medicine" of the city of St. Petersburg", city: Saint Petersburg, zip: 195271, country: Russian Federation, geoPoint lat: 59.93863, lon: 30.31413, locations facility: "Euro Cityclinic" LLC, city: Saint Petersburg, zip: 197022, country: Russian Federation, geoPoint lat: 59.93863, lon: 30.31413, locations facility: St. Petersburg State Budgetary Healthcare Institution "City Clinical Oncological Dispensary", city: Saint Petersburg, zip: 197022, country: Russian Federation, geoPoint lat: 59.93863, lon: 30.31413, locations facility: State Budgetary Healthcare Institution "Samara Regional Clinical Oncological Dispensary", city: Samara, zip: 443031, country: Russian Federation, geoPoint lat: 53.20007, lon: 50.15, locations facility: State Healthcare Institution "Regional Clinical Oncological Dispensary", city: Saratov, zip: 410053, country: Russian Federation, geoPoint lat: 51.54056, lon: 46.00861, locations facility: Regional State Budgetary Healthcare Institution "Smolensk Regional Oncological Clinical Dispensary", city: Smolensk, zip: 214000, country: Russian Federation, geoPoint lat: 54.7818, lon: 32.0401, locations facility: Siberian State Medical University of the Ministry of Healthcare of Russian Federation, city: Tomsk, zip: 634050, country: Russian Federation, geoPoint lat: 56.49771, lon: 84.97437, locations facility: The State Autonomous healthcare Institution of the Tyumen region "Multidisciplinary clinical Medical Center "Medical City", city: Tyumen, zip: 625041, country: Russian Federation, geoPoint lat: 57.15222, lon: 65.52722, hasResults: False