10 mg/day
prednisolone) or any other immunosuppressive drugs within 14 days prior to
randomization. The use of inhaled and topical corticosteroids is allowed.
10. History of (non-infectious) pneumonitis requiring corticosteroid therapy or
pneumonitis at the time of screening.
11. Any anticancer therapy or major surgery within 28 days prior to randomization, or
the subject's AE (other than alopecia) caused by anticancer therapy has not yet
recovered to CTCAE grade 1 or has not completely resolved.
12. Concomitant use of drugs or medical devices studied in other clinical studies or
their use within 28 days prior to randomization.
13. Infections requiring therapy or systemic antibiotics within 14 days prior to
randomization.
14. Administration of a live and/or attenuated vaccine within 28 days prior to
randomization.
15. Positive HIV-1 or HIV-2 test.
16. HBV/HCV infections (subjects with a negative PCR result for hepatitis C virus RNA,
without significant abnormalities in blood chemistry tests, examined by an
infectious disease specialist and not requiring specific antiviral treatment at the
time of screening, may be included in the study. Subjects with a positive HbsAg test
result cannot be included in the study).
17. Impossibility to administer intravenous contrast agents (including due to
hypersensitivity to contrast media).
18. Hypersensitivity or allergy to any of the nivolumab product components.
Hypersensitivity or allergy to medicinal products obtained based on Chinese hamster
ovary cells, or history of severe allergic, anaphylactic or other hypersensitivity
reactions to chimeric or humanized antibodies or hybrid proteins.
19. Pregnancy or breastfeeding, as well as intention to become pregnant or father a
child during the study period.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Healthcare Institution "Brest Regional Oncological Dispensary"
Address:
City:
Brest
Country:
Belarus
Status:
Recruiting
Contact:
Last name:
Vitalii S Volkov
Phone:
+375 (0162) 97-83-03
Email:
biocad@biocad.ru
Facility:
Name:
Health Institution "Gomel Regional Clinical Oncology Center"
Address:
City:
Gomel
Country:
Belarus
Status:
Recruiting
Contact:
Last name:
Vasilii N Belyakovskii
Phone:
+7 (812) 380 49 33
Email:
mail@gokod.by
Facility:
Name:
Healthcare Institution "Minsk City Clinical Cancer Center"
Address:
City:
Minsk
Zip:
220013
Country:
Belarus
Status:
Recruiting
Contact:
Last name:
Svetlana A Demidova
Phone:
+375 17 237 32 90
Email:
onko@mgkod.by
Facility:
Name:
State Institution "Republic Scientific and Practical Centre for Oncology and Medical Radiology Named after N.N.Aleksandrov"
Address:
City:
Minsk
Zip:
223040
Country:
Belarus
Status:
Recruiting
Contact:
Last name:
Olga Sergeeva
Phone:
+ 375172652301
Email:
oncobel@omr.by
Facility:
Name:
Shaheed Zulfiqar Ali Bhutto Medical University
Address:
City:
Islamabad
Country:
Pakistan
Status:
Recruiting
Contact:
Last name:
Qasim Mahmood Buttar
Phone:
biocad@biocad.ru
Email:
biocad@biocad.ru
Facility:
Name:
Rehman Medical Institute
Address:
City:
Peshawar
Country:
Pakistan
Status:
Recruiting
Contact:
Last name:
Abdul Wahid
Phone:
biocad@biocad.ru
Email:
biocad@biocad.ru
Facility:
Name:
Chelyabinsk Regional Clinical Center for Oncology and Nuclear Medicine
Address:
City:
Chelyabinsk
Zip:
454087
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Natalya V Fadeeva, MD, PhD
Phone:
+7 (351) 214 88 8
Email:
onco74@chelonco.ru
Facility:
Name:
Clinical Oncologic Dispensary No. 1
Address:
City:
Krasnodar
Zip:
350040
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Julia M Makarova, MD
Phone:
+7-(812)-380-49-34
Email:
biocad@biocad.ru
Facility:
Name:
Krasnoyarsk Regional Clinical Oncological Dispensary named after A.I. Kryzhanovsky
Address:
City:
Krasnoyarsk
Zip:
660133
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Ruslan A Zukov, MD, PhD
Phone:
+7-(812)-380-49-34
Email:
biocad@biocad.ru
Facility:
Name:
State Budgetary Institution of Healthcare of the Arkhangelsk Region "Severodvinsk City Hospital №2 of Emergency"
Address:
City:
Arkhangel'sk
Zip:
164523
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Marina Nechaeva, MD
Phone:
+7 (8184) 53-26-83
Email:
hospit2@yandex.ru
Facility:
Name:
Regional State Budgetary Healthcare Institution "Altai Regional Oncological Dispensary"
Address:
City:
Barnaul
Zip:
656045
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Denis Tantsyrev
Phone:
+7 (3852) 507 355
Email:
akod@zdravalt.ru
Facility:
Name:
Sverdlovsk Regional Oncology Center
Address:
City:
Ekaterinburg
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Oksana E Shirokova, MD, PhD
Phone:
+7 (343) 356 17 31
Email:
cood@uralonco.ru
Facility:
Name:
Ivanovo Regional Oncology Center
Address:
City:
Ivanovo
Zip:
153013
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Evgenii Gotovkin
Phone:
+7 (4932) 56 23 12
Email:
onko@ivreg.ru
Facility:
Name:
State Health Care Institution "Republican Clinical Cancer Center," the Ministry of Health of the Udmurt Republic
Address:
City:
Izhevsk
Zip:
426009
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Nadezhda Leushina
Phone:
+7 (3412) 50 88 00
Email:
biocad@biocad.ru
Facility:
Name:
State Budgetary Health Institution "Regional Clinical Hospital of Kaliningrad Region"
Address:
City:
Kaliningrad
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Mikhail Agapov
Phone:
+7 (4012) 99 44 80
Email:
okb@infomed39.ru
Facility:
Name:
State Budgetary Healthcare Institution of Kaluga Region "Kaluga Region Clinical Oncological Dispensary"
Address:
City:
Kaluga
Zip:
248007
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Irina Rozhkova
Phone:
+7 (903) 81 11 911
Email:
Gbuz_onkodisp@adm.kaluga.ru
Facility:
Name:
State Autonomous Health Institution "Republican Clinical Oncology Dispensary of the Ministry of Health of the Republic of Tatarstan named after Professor M.Z. Sigal"
Address:
City:
Kazan
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Alfia Nesterova, MD
Phone:
+7 (843) 202 3 202
Email:
rkod.mzrt@tatar.ru
Facility:
Name:
State Autonomous Health Institution "Republican Clinical Oncology Dispensary of the Ministry of Health of the Republic of Tatarstan named after Professor M.Z. Sigal"
Address:
City:
Kazan
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Sufia Z Safina, MD
Phone:
+7 (843) 202 3 202
Email:
rkod.mzrt@tatar.ru
Facility:
Name:
"Russian Cancer Research Center named after N.N. Blokhin "of the Ministry of Health of the Russian Federation
Address:
City:
Moscow
Zip:
115478
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Kristina Orlova
Phone:
+74993242424
Email:
info@ronc.ru
Facility:
Name:
JSC "Medsi Group"
Address:
City:
Moscow
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Anastasiia S Mochalova
Phone:
+7 (495) 021 47 02
Email:
biocad@biocad.ru
Facility:
Name:
Moscow City Oncology Hospital No. 62
Address:
City:
Moscow
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Daniil L Stroyakovsky, MD, PhD
Phone:
+7 (495) 536 01 00
Email:
gob62@zdrav.mos.ru
Facility:
Name:
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"
Address:
City:
Moscow
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Marina A Lyadova
Phone:
+7 (499) 261 30 42
Email:
gkob1@zdrav.mos.ru
Facility:
Name:
State Budgetary Healthcare Institution "Moscow Clinical Scientific Center funded by Moscow Health Department" (SBHI MCSC MHD)
Address:
City:
Moscow
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Karina Vorontsova, MD PhD
Phone:
+7 (495) 304 30 39
Email:
info@mknc.ru
Facility:
Name:
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"
Address:
City:
Moscow
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Mikhail Yu Fedyanin
Phone:
+7 (495) 744 07 03
Email:
mmcc@zdrav.mos.ru
Facility:
Name:
Nizhny Novgorod Region State Budgetary Healthcare Institution "Nizhny Novgorod Regional Clinical Oncological Dispensary"
Address:
City:
Nizhny Novgorod
Zip:
603126
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Irina S Shumskaya
Phone:
+7 (831) 282 00 01
Email:
sekretar_gu@nnood.ru
Facility:
Name:
State Budgetary Healthcare Institution "Novosibirsk Regional Clinical Oncology Center" of the Novosibirsk Region
Address:
City:
Novosibirsk
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Vadim V Kozlov
Phone:
+7 (383) 382 80 46
Email:
nood@nso.ru
Facility:
Name:
State budget healthcare institution Omsk region "Clinical Oncology Dispensary"
Address:
City:
Omsk
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Anastasiya Zimina, MD
Phone:
+7 (3812) 60 16 95
Email:
omonkol_mail@minzdrav.omskportal.ru
Facility:
Name:
Perm Region Oncology Dispensary
Address:
City:
Perm
Zip:
614066
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Andrey Khorinko
Phone:
+7 (342) 258 03 43
Email:
onko-perm@med.permkrai.ru
Facility:
Name:
State Budgetary Healthcare Institution of Perm Krai "Order of Honour" Perm Regional Clinical Hospital "
Address:
City:
Perm
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Yulia Trefilova
Phone:
+7 (342) 239 31 54
Email:
pkkb@med.permkrai.ru
Facility:
Name:
Federal Government Budgetary Institution "National Institute of Cancer Research" of Ministry of Health of Russian Federation
Address:
City:
Rostov-on-Don
Zip:
314019
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Liubov Vladimirova
Phone:
+7 (800) 250 37 40
Email:
onko-sekretar@mail.ru
Facility:
Name:
JSC "Modern Medical Technologies"
Address:
City:
Saint Petersburg
Zip:
190013
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Svetlana V Odintsova, MD
Phone:
+7-(812)-2104028
Email:
info@cmtmed.com
Facility:
Name:
Private healthcare institution "Clinical hospital "RZD-Medicine" of the city of Saint Petersburg"
Address:
City:
Saint Petersburg
Zip:
195271
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Aleksandr G Vasiliev
Phone:
+7 (812) 67 97 003
Email:
reception@rwmed.ru
Facility:
Name:
Saint-Petersburg Petersburg Clinical Scientific and Practical Center for Specialized Types of Medical Care (Oncological)
Address:
City:
Saint Petersburg
Zip:
197758
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Vladimir M Moiseenko, MD, PhD
Phone:
+7-(812)-380-49-34
Email:
biocad@biocad.ru
Facility:
Name:
JSC "North-West Centre of Evidence-Based Mediccine"
Address:
City:
Saint Petersburg
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Aleksei Shmelev
Phone:
+7 (800) 234 42 00
Email:
info@cdmed.ru
Facility:
Name:
Limited Liability Company "Oncological Research Center"
Address:
City:
Saint Petersburg
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Timur T Andabecov
Phone:
+7 (812) 409 96 63
Email:
reception@spbonc.ru
Facility:
Name:
Private Medical Institution Evromedservis
Address:
City:
Saint Petersburg
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Konstantin D Pen'kov
Phone:
+7 (812) 400 00 70
Email:
emeds.spb@yandex.ru
Facility:
Name:
Federal State Budgetary Institution "N.N. Petrov Research Institute of Oncology" of the Ministry of Healthcare of the Russian Federation
Address:
City:
Saint-Petersburg
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Svetlana Protsenko
Phone:
+7 (812) 43-99-555
Email:
oncl@rion.spb.ru
Facility:
Name:
State-financed Health Institution "Samara Region Clinical Oncology Dispensary"
Address:
City:
Samara
Zip:
443031
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Yulia Makarycheva
Phone:
+7 (846) 994 61 96
Email:
info@samaraonko.ru
Facility:
Name:
Federal State Educational Institution of Higher Professional Education "Mordovia State University N.P. Ogareva "
Address:
City:
Saransk
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Pavel Skopin, PhD
Phone:
+7 (8342) 24 37 32
Email:
depgeneral@adm.mrsu.ru
Facility:
Name:
Provincial health official body "Smolensk Regional Clinical Oncological Dispensary"
Address:
City:
Smolensk
Zip:
214000
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Elena Semkina
Phone:
+7 (4812) 38 49 53
Email:
onkolog2016@mail.ru
Facility:
Name:
Federal State Budgetary Educational Institution of Higher Education "Siberian State Medical University" of the Ministry of Health of the Russian Federation
Address:
City:
Tomsk
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Nataliya Varviyanskaya
Phone:
+7 (3822) 90 98 23
Email:
office@ssmu.ru
Facility:
Name:
Federal State Budgetary Institution of Health "Tver Regional Clinical Oncological Dispensary" of the Tver Region
Address:
City:
Tver
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Aleksandra Saidullaeva
Phone:
+7 (4822) 58 33 64
Email:
onkodispanser-tver@yandex.ru
Facility:
Name:
State Autonomus Institution of Health "Mulitiprofile Clinical Medical Centre "Medical City""
Address:
City:
Tyumen
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Shidin Vladimir
Phone:
+7 (3452) 52 03 03
Email:
meditsinskii_gorod@mail.ru
Facility:
Name:
Republican Clinical Oncology Dispensary of Ministry of Health republic Bashkortostan
Address:
City:
Ufa
Zip:
450054
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Aleksander Sultanbaev
Phone:
+7 (347) 216 49 71
Email:
ufa.rkod@doctorrb.ru
Facility:
Name:
State Health Care Institution "Volgograd Regional Clinical Oncology Dispensary № 1"
Address:
City:
Volgograd
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Nadezhda V Kovalenko, MD
Phone:
+7 (8442) 609 608
Email:
vokod@volganet.ru
Start date:
March 21, 2024
Completion date:
March 2027
Lead sponsor:
Agency:
Biocad
Agency class:
Industry
Source:
Biocad
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06640530
