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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

266

Participants

Timeline

Start Date

September 27, 2023

Primary Completion Date

June 30, 2024

Study Completion Date

January 31, 2026

Conditions
Skin Melanoma
Interventions
DRUG

RPH-075

"100 mg/4 mL (25 mg/mL) concentrate for solution for infusions in a single-dose vial~The required volume (8 ml) of the Drug concentrate solution should be withdrawn from the vials and transferred into an intravenous bag containing 0.9% Sodium Chloride Injection or 5% Dextrose Injection. (The final concentration of the diluted solution should be between 1 mg/mL to 10 mg/mL.)"

DRUG

Keytruda®

"100 mg/4 mL (25 mg/mL) concentrate for solution for infusions in a single-dose vial~The required volume (8 ml) of the Drug concentrate solution should be withdrawn from the vials and transferred into an intravenous bag containing 0.9% Sodium Chloride Injection or 5% Dextrose Injection. (The final concentration of the diluted solution should be between 1 mg/mL to 10 mg/mL.)"

Trial Locations (36)

108814

"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", Moscow

115478

"Federal State Budgetary Institution N.N. Blokhin National Medical Research Center of Oncology of the Ministry of Health of the Russian Federation", Moscow

117152

"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", Moscow

119991

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), Moscow

121205

"Branch Office of Hadassah Medical Ltd", Moscow

121552

"Moscow Center for Rehabilitation Treatment LLC", Moscow

123056

Medsi Group of Companies JSC, Moscow

127521

"Research lab LLC", Moscow

143515

"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

153040

"Regional budgetary healthcare institution Ivanovo Regional Oncological Dispensary", Ivanovo

163045

"State Budgetary Healthcare Institution of the Arkhangelsk region Arkhangelsk Clinical Oncological Dispensary", Arkhangelsk

188300

State Budgetary Healthcare Institution Leningrad Regional Clinical Hospital, Saint Petersburg

195271

"Private healthcare institution Clinical Hospital Russian Railways-Medicine of the city of St. Petersburg", Saint Petersburg

197022

"Euro Cityclinic LLC", Saint Petersburg

"St. Petersburg State Budgetary Healthcare Institution City Clinical Oncological Dispensary", Saint Petersburg

214000

"Regional State Budgetary Healthcare Institution Smolensk Regional Oncological Clinical Dispensary", Smolensk

248007

"Kaluga Region State Budgetary Healthcare Institution Kaluga Regional Clinical Oncological Dispensary", Kaluga

249036

"Federal State Budgetary Institution National Medical Research Center of Radiology of the Ministry of Health of the Russian Federation", Obninsk

305524

"Regional Budgetary Healthcare Institution Kursk Oncological Research and Clinical Center named after G.E. Ostroverkhov", Kislino

350040

"State Budgetary Healthcare Institution Clinical Oncological Dispensary No. 1 of the Ministry of Health of the Krasnodar Territory", Krasnodar

357502

"The State budgetary healthcare Institution of the Stavropol Territory Pyatigorsk Interdistrict Oncological Dispensary", Pyatigorsk

410053

"State Healthcare Institution Regional Clinical Oncological Dispensary", Saratov

420029

"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'

426009

"Budgetary Healthcare Institution of the Udmurt Republic Sergey Grigoryevich Primushko Republican Clinical Oncological Dispensary of the Ministry of Health of the Udmurt Republic", Izhevsk

443031

"State Budgetary Healthcare Institution Samara Regional Clinical Oncological Dispensary", Samara

450054

State Autonomous Healthcare Institution Republican Clinical Oncological Dispensary of the Ministry of Health of the Republic of Bashkortostan, Ufa

603126

"State Budgetary Healthcare Institution of the Nizhny Novgorod region Nizhny Novgorod Regional Clinical Oncological Dispensary", Nizhny Novgorod

614066

"State Budgetary Healthcare Institution of the Perm Territory Perm Regional Oncological Dispensary", Perm

620036

"The State Autonomous Healthcare Institution of the Sverdlovsk region Sverdlovsk Regional Oncological Dispensary", Yekaterinburg

625041

"The State Autonomous healthcare Institution of the Tyumen region Multidisciplinary clinical Medical Center Medical City", Tyumen

630108

"State Budgetary Healthcare Institution of the Novosibirsk region Novosibirsk Regional Clinical Oncological Dispensary", Novosibirsk

634050

Siberian State Medical University of the Ministry of Healthcare of Russian Federation, Tomsk

644013

"Budgetary healthcare institution of the Omsk region Clinical Oncological Dispensary", Omsk

650036

"State Budgetary healthcare Institution Kuzbass Clinical Oncological Dispensary named after M.S. Rappoport", Kemerovo

660133

"Regional State Budgetary Healthcare Institution Krasnoyarsk Regional Clinical Oncological Dispensary named after A.I. Kryzhanovsky", Krasnoyarsk

664035

"State Budgetary Healthcare Institution Regional Oncological Dispensary", Irkutsk

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Data Management 365

INDUSTRY

collaborator

Exacte Labs LLC

INDUSTRY

collaborator

Federal State Budgetary Institution of the Central Research Institute of Epidemiology of Rospotrebnadzor

UNKNOWN

lead

R-Pharm

INDUSTRY