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Study identifier: NCT06320353 Synced from ClinicalTrials.gov · August 02, 2026
● Completed

Study сomparing the Efficacy and Safety of RPH-075 and Keytruda® in Patients With Unresectable or Metastatic Skin Melanoma

Condition: Skin Melanoma  ·  Sponsor: R-Pharm

PhasePhase 3
Planned participants266
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

No contact information is available for this study as per the public registry record.

Always discuss trial participation with your own doctor first.

Locations (36)

Federal State Budgetary Institution "National Medical Research Center of Radiology" of the Ministry of Health of the Russian FederationObninsk, Kaluga Oblast, Russia
State Budgetary Healthcare Institution "Clinical Oncological Dispensary No. 1" of the Ministry of Health of the Krasnodar TerritoryKrasnodar, Krasnodar Territory, Russia
Regional Budgetary Healthcare Institution "Kursk Oncological Research and Clinical Center named after G.E. Ostroverkhov"Kislino, Kursk Oblast, Russia
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"Istra, Moscow Oblast, Russia
The State budgetary healthcare Institution of the Stavropol Territory "Pyatigorsk Interdistrict Oncological Dispensary"Pyatigorsk, Stavropol Territory, Russia
The State Autonomous Healthcare Institution of the Sverdlovsk region "Sverdlovsk Regional Oncological Dispensary"Yekaterinburg, Sverdlovsk Oblast, Russia
State Autonomous Healthcare Institution Republican Clinical Oncological Dispensary of the Ministry of Health of the Republic of BashkortostanUfa, The Republic of Bashkortostan, Russia
State Autonomous Healthcare Institution "Republican Clinical Oncological Dispensary of the Ministry of Health of the Republic of Tatarstan named after Professor M.Z.Segal"Kazan', The Republic of Tatarstan, Russia
Budgetary Healthcare Institution of the Udmurt Republic "Sergey Grigoryevich Primushko Republican Clinical Oncological Dispensary of the Ministry of Health of the Udmurt Republic"Izhevsk, Udmurt Republic, Russia
State Budgetary Healthcare Institution of the Arkhangelsk region "Arkhangelsk Clinical Oncological Dispensary"Arkhangelsk, Russia
State Budgetary Healthcare Institution "Regional Oncological Dispensary"Irkutsk, Russia
Regional budgetary healthcare institution "Ivanovo Regional Oncological Dispensary"Ivanovo, Russia

+ 24 more locations — full list on the registry record.

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