protocolSection identificationModule nctId: NCT06307093, orgStudyIdInfo id: CL01860198, briefTitle: Study Comparing the Pharmacokinetics, Safety, and Efficacy of RPH-075 and Keytruda® in Patients With Malignant Neoplasms, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-03-01, primaryCompletionDateStruct date: 2023-12-11, completionDateStruct date: 2025-07, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: R-Pharm, class: INDUSTRY, collaborators name: Data Management 365, collaborators name: Exacte Labs LLC, collaborators name: Federal State Budgetary Institution "NMIC of Hematology" of the Ministry of Health of the Russian Federation, 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 pharmacokinetic properties, as well as the comparability of safety, immunogenicity and pharmacodynamics of the drug RPH-075 (international nonproprietary name (INN) is pembrolizumab) in comparison with the drug Keytruda® (INN is pembrolizumab) after a single intravenous injection to patients with malignant neoplasms as a first or second line therapy in a monotherapy regimen.The main main tasks are:* To evaluate and compare the pharmacokinetic properties of RPH-075 and Keytruda® after a single intravenous administration of pembrolizumab to patients with malignant neoplasms;* To evaluate the safety profile of the drug RPH-075 in comparison with the drug Keytruda® when used in patients with malignant neoplasms when used as a 1st or 2nd line therapy in a monotherapy regimen.This study will also include a comparative assessment of immunogenicity, pharmacodynamic parameters and a pilot evaluation of RPH-075 efficacy., conditionsModule conditions: Skin Melanoma, conditions: Squamous Non-small-cell Lung Cancer, conditions: Head and Neck Squamous Cell Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 90, type: ACTUAL, armsInterventionsModule interventions name: RPH-075, interventions name: Keytruda®, outcomesModule primaryOutcomes measure: Area under the curve "concentration-time" (AUC(0-504)) of pembrolizumab, primaryOutcomes measure: Incidence of Adverse Reactions (ARs), secondaryOutcomes measure: Maximum Plasma Concentration (Cmax) of pembrolizumab, secondaryOutcomes measure: Maximum serum concentration of pembrolizumab at steady state (Сmax ss), secondaryOutcomes measure: Minimal serum concentration of pembrolizumab at steady state (Сmin ss), secondaryOutcomes measure: Area under the curve "concentration-time" of pembrolizumab at steady state (AUCtau ss), secondaryOutcomes measure: Incidence of Treatment-Emergent Adverse Events (AEs), secondaryOutcomes measure: Incidence of Immune-mediated adverse reactions (imARs), secondaryOutcomes measure: Incidence of Treatment-Emergent AEs with grade 3 or more, secondaryOutcomes measure: Incidence of Treatment-Emergent ARs with grade 3 or more, secondaryOutcomes measure: Incidence of imARs with grade 3 or more, secondaryOutcomes measure: Incidence of serious adverse events (SAEs), secondaryOutcomes measure: Incidence of serious adverse reactions (SARs), secondaryOutcomes measure: The proportion of patients (%) who required therapy discontinuation due to AR development, secondaryOutcomes measure: The proportion of patients (%) who developed binding antibodies and neutralizing antibodies to pembrolizumab, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule 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: 143423, country: Russian Federation, geoPoint lat: 55.91997, lon: 36.86867, locations facility: "New Clinic" LLC, city: Pyatigorsk, state: Stavropol Territory, zip: 357500, country: Russian Federation, geoPoint lat: 44.04861, lon: 43.05944, locations facility: Regional State Budgetary Healthcare Institution "Altai Regional Oncological Dispensary", city: Barnaul, state: The Altai Republic, zip: 656045, country: Russian Federation, geoPoint lat: 53.36056, lon: 83.76361, locations facility: Autonomous Institution of the Chuvash Republic "Republican Clinical Oncological Dispensary" of the Ministry of Health of the Chuvash Republic, city: Cheboksary, state: The Chuvash Republic, zip: 428020, country: Russian Federation, geoPoint lat: 56.13222, lon: 47.25194, 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 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: Regional budgetary healthcare institution "Ivanovo Regional Oncological Dispensary", city: Ivanovo, zip: 153040, country: Russian Federation, geoPoint lat: 56.99719, lon: 40.97139, 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: 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: 105005, country: Russian Federation, geoPoint lat: 55.75222, lon: 37.61556, locations facility: State Budgetary Institution of Healthcare of the city of Moscow "Moscow Clinical Scientific and Practical Center named after A.S. Loginov of the Department of Healthcare of the City of Moscow", city: Moscow, zip: 111123, 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: Federal State Budgetary Scientific Institution "Russian Scientific Center of Surgery named after Academician B.V. Petrovsky", city: Moscow, zip: 119435, country: Russian Federation, geoPoint lat: 55.75222, lon: 37.61556, locations facility: 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), city: Moscow, zip: 119991, 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 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: "Av Medical Group" LLC, city: Saint Petersburg, zip: 196006, 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: Federal State Budgetary Institution "N.N. Petrov National Medical Research Center of Oncology" of the Ministry of Health of the Russian Federation, city: Saint Petersburg, zip: 197758, 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: 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