Trial Title:
A Clinical Study of BCD-217 (Nurulimab + Prolgolimab) Followed by Anti-PD-1 Compared to Anti-PD-1 Monotherapy as First-Line Treatment in Subjects With Unresectable/Metastatic Melanoma
NCT ID:
NCT05732805
Condition:
Melanoma
Melanoma (Skin)
Melanoma Stage III
Melanoma Stage IV
Melanoma Unresectable
Melanoma Metastatic
Melanoma Advanced
Conditions: Official terms:
Melanoma
Conditions: Keywords:
PD-1
CTLA-4
prolgolimab
nurulimab
immunotherapy
checkpoint inhibitors
CPI
programm death
cytotoxic T-lymphocyte-associated protein
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Investigator)
Intervention:
Intervention type:
Biological
Intervention name:
BCD-217
Description:
Subject recieves BCD-217 0.2 mL/kg, which is equivalent to 1 mg/kg nurulimab + 3 mg/kg
prolgolimab, as an intravenous infusion once every 3 weeks (Q3W) simultaneously with
placebo, a total of 4 intravenous infusions. Beginning with the 5th infusion, subjects
are switched to prolgolimab 1 mg/kg monotherapy once every 2 weeks (Q2W).
Arm group label:
BCD-217 (nurulimab + prolgolimab)
Other name:
nurulimab+prolgolimab
Intervention type:
Biological
Intervention name:
BCD-100
Description:
Subject recieves prolgolimab 3 mg/kg as an intravenous infusion once every 3 weeks (Q3W)
simultaneously with placebo, a total of 4 intravenous infusions. Beginning with the 5th
infusion, subjects are switched to prolgolimab 1 mg/kg monotherapy once every 2 weeks
(Q2W).
Arm group label:
BCD-100 (prolgolimab)
Arm group label:
BCD-217 (nurulimab + prolgolimab)
Other name:
prolgolimab
Other name:
Forteca
Intervention type:
Biological
Intervention name:
Placebo
Description:
Placebo
Arm group label:
BCD-100 (prolgolimab)
Arm group label:
BCD-217 (nurulimab + prolgolimab)
Summary:
The aim of study is to investigate the efficacy, safety, immunogenicity,
pharmacokinetics, and pharmacodynamics of BCD-217 followed by prolgolimab monotherapy
versus prolgolimab monotherapy as first-line therapy in subjects with unresectable or
metastatic melanoma.
Detailed description:
This study is designed as a phase III, randomized, double-blind, placebo-controlled
study.
After the stratification procedure, subjects are randomized in a 1:1 ratio into 2 groups:
- BCD-217 + placebo (4 doses) → prolgolimab (BCD-217 group)
- Prolgolimab + placebo (4 doses) → prolgolimab (BCD-100 monotherapy group)
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Signed informed consent and the subject's ability to comply with the requirements of
the clinical study protocol;
2. Age ≥18 years at the time of signing the informed consent form;
3. Histologically confirmed melanoma (with available documented evidence of relevant
investigations);
4. Untreated unresectable stage III melanoma or untreated metastatic (stage IV)
melanoma;
5. Available blocks for histological examination and/or the subject's consent to
undergo biopsy ;
6. Consent to the evaluation of the PD-L1 status and BRAF V600 mutation status at a
central laboratory;
7. ECOG score 0-1;
8. Life expectancy of at least 12 weeks ;
9. Measurable target tumor lesions (at least 1 lesion) according to RECIST 1.1 criteria
, confirmed by central independent reviewer;
10. In subjects of childbearing potential, willingness to use reliable contraceptive
measures throughout the study, from the signing of the informed consent form and for
additional 24 weeks after the administration of the last dose of the investigational
product.
Exclusion Criteria:
1. Indications for radical (surgical, radiation) therapy;
2. A history of previous systemic antitumor therapy for unresectable or metastatic
melanoma ;
3. Prior therapy with checkpoint inhibitors (e.g., anti-CTLA-4 and/or
anti-PD-1/PD-L1/PD-L2 products);
4. Prior therapy with BRAF and MEK protein kinase inhibitors;
5. Use of immunostimulants, monoclonal antibodies and/or colony-stimulating factors
within less than 4 weeks prior to randomization in the study;
6. Ocular melanoma;
7. Mucosal melanoma;
8. CNS metastases;
9. Impossibility to determine PD-L1 status and/or BRAF status;
10. Subjects with severe comorbidities, life-threatening acute complications of the
primary disease (including massive pleural, pericardial, or peritoneal effusions
requiring intervention , pulmonary lymphangitis, bleeding, or organ perforation) at
the time of signing the informed consent form;
11. Ongoing concomitant diseases at the time of screening, which increase the risk of
severe adverse events during the administration of the study therapy:
- stable angina, functional class III-IV;
- unstable angina or a history of myocardial infarction within less than 6 months
prior to signing the informed consent form;
- moderate to severe heart failure (classes III and IV according to NYHA
classification);
- uncontrolled hypertension (systolic blood pressure >150 mmHg or diastolic blood
pressure >90 mmHg) ;
- a history of atopic asthma , angioedema;
- respiratory failure (moderate to severe), grade 3 or 4 chronic obstructive
pulmonary disease;
- any other concomitant diseases (including, but not limited to, metabolic,
hematological, renal, hepatic, pulmonary, neurological, endocrine, cardiac,
infectious, gastrointestinal disorders), which expose the subject to an
unacceptable risk during the study therapy;
12. Known or suspected systemic autoimmune diseases (including, but not limited to,
systemic lupus erythematosus, Crohn's disease, nonspecific ulcerative colitis,
systemic scleroderma, inflammatory myopathy, mixed connective tissue disease,
overlap syndrome, etc.) ;
13. History of interstitial pulmonary disease or pneumonitis requiring systemic
glucocorticoids;
14. The need for glucocorticoid therapy (at >10 mg/day prednisolone equivalent doses) or
any other drugs with immunosuppressive effects within 14 days prior to
randomization;
15. Hematologic abnormalities :
- neutrophils <1.5×109/L;
- platelets <100×109/L;
- hemoglobin <90 g/L;
16. Renal impairment: creatinine ≥2.5×ULN;
17. Hepatic impairment :
- total bilirubin ≥3×ULN (except for subjects with Gilbert's syndrome, in whom
bilirubin levels should not exceed 50 μmol/L),
- AP, AST or ALT ≥2.5×ULN (≥5×ULN in case of subjects with liver metastases);
18. Any antitumor treatment within less than 4 weeks or surgery within less than 28 days
prior to randomization within the study;
19. History of oncological disease, except for radically treated diseases with remission
for over 5 years prior randomization in this study ;
20. Conditions limiting the subject's ability to comply with the Protocol requirements
(in the Investigator's opinion );
21. Participation in other clinical studies within less than 30 days prior to
randomization and during this clinical study ;
22. Acute infections or activation of chronic infectious diseases or systemic
antibacterial therapy within less than 28 days prior to randomization;
23. Active hepatitis B, active hepatitis C (confirmed by PCR), active syphilis,
HIV-infection, currently or previously ;
24. Impossibility to administer the investigational product intravenously;
25. Impossibility to administer intravenous contrast agents (including due to
hypersensitivity to contrast media);
26. Hypersensitivity to any of the components of BCD-100 or BCD-217;
27. A history of hypersensitivity to monoclonal antibody products;
28. Pregnancy or breastfeeding.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Healthcare Institution "Bobruisk Interdistrict Oncological Dispensary"
Address:
City:
Babruysk
Country:
Belarus
Status:
Recruiting
Contact:
Last name:
Igor A Sharf
Phone:
+375225 736262
Email:
uz@bmod.by
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:
Health care institution "Grodno University Clinic"
Address:
City:
Grodno
Country:
Belarus
Status:
Recruiting
Contact:
Last name:
Dmitrii P Norik
Phone:
+375 (152) 436230
Email:
regclinic@gocb.by
Facility:
Name:
State Institution "Republican Scientific and Practical Center of Oncology and Medical Radiology named after A.I. N.N. Alexandrov"
Address:
City:
Lesnoy
Country:
Belarus
Status:
Recruiting
Contact:
Last name:
Nikolaii B Ermakov
Phone:
(+375 17) 265-23-01
Email:
oncobel@omr.med.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 "Mogilev Regional Oncological Dispensary"
Address:
City:
Mogilev
Country:
Belarus
Status:
Recruiting
Contact:
Last name:
Natalia I Ivanova
Phone:
+7 (812) 380 49 33
Email:
info@mood.by
Facility:
Name:
Healthcare Institution "Vitebsk Regional Clinical Oncology Center"
Address:
City:
Vitebsk
Country:
Belarus
Status:
Recruiting
Contact:
Last name:
Aleksei L Obukhov
Phone:
+ 375 (212) 57-40-31
Email:
biocad@biocad.ru
Facility:
Name:
Fortis Hospital
Address:
City:
Faridabad
Country:
India
Status:
Recruiting
Contact:
Last name:
Amit Bhargava, MD
Email:
biocad@biocad.ru
Facility:
Name:
Kasturba Medical College and Hospital
Address:
City:
Mangalore
Country:
India
Status:
Recruiting
Contact:
Last name:
M S Athiyamaan, MD
Email:
biocad@biocad.ru
Facility:
Name:
TATA Memorial Hospital
Address:
City:
Mumbai
Country:
India
Status:
Recruiting
Contact:
Last name:
Prabhat G Bhargava, MD
Email:
biocad@biocad.ru
Facility:
Name:
HealthCare Global Enterprises Ltd, NCHRI Cancer Center
Address:
City:
Nagpur
Country:
India
Status:
Recruiting
Contact:
Last name:
Ajay O Mehta, MD
Email:
biocad@biocad.ru
Facility:
Name:
HealthCare Global Enterprises Ltd Manavata cancer Centre
Address:
City:
Nashik
Country:
India
Status:
Recruiting
Contact:
Last name:
Rajnish Nagarkar, MD
Email:
biocad@biocad.ru
Facility:
Name:
Sankalp Superspeciality Hospital
Address:
City:
Nashik
Country:
India
Status:
Recruiting
Contact:
Last name:
Bhushan Nemade, MD
Email:
biocad@biocad.ru
Facility:
Name:
All India Institute of Medical Science
Address:
City:
New Delhi
Country:
India
Status:
Recruiting
Contact:
Last name:
Sameer Rastogi, MD
Email:
biocad@biocad.ru
Facility:
Name:
Deenanath Mangeshkar Hospital & Research Center
Address:
City:
Pune
Country:
India
Status:
Recruiting
Contact:
Last name:
Chetanavata Deshmukh, MD
Email:
biocad@biocad.ru
Facility:
Name:
PDEAS Ayurved Rugnalaya & Steriling Multispeciality Hospital
Address:
City:
Pune
Country:
India
Status:
Recruiting
Contact:
Last name:
Rakesh Neve, MD
Email:
biocad@biocad.ru
Facility:
Name:
Horizon Mulitispeciality Hospital
Address:
City:
Sangli
Country:
India
Status:
Recruiting
Contact:
Last name:
Vaibhav Amale, MD
Email:
biocad@biocad.ru
Facility:
Name:
Shalby Hospital
Address:
City:
Surat
Country:
India
Status:
Recruiting
Contact:
Last name:
Kaushal Patel, MD
Email:
biocad@biocad.ru
Facility:
Name:
Kiran Multispeciality hospital &Research
Address:
City:
Sūrat
Country:
India
Status:
Recruiting
Contact:
Last name:
Anshul Agrawal, MD
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-(812)-380-49-34
Email:
biocad@biocad.ru
Facility:
Name:
LLC "New Clinic"
Address:
City:
Pyatigorsk
Zip:
357500
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Victoria V Chistyakova
Phone:
+7 (8793) 97 45 31
Email:
newclinic@list.ru
Facility:
Name:
Arkhangelsk Clinical Oncology Dispensary
Address:
City:
Arkhangel'sk
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Yana S Chapko, MD
Phone:
+7 (8182) 27 57 74
Email:
secretar@onko29.ru
Facility:
Name:
Regional State Budgetary Institution of Health Care "Altai Regional Oncological Dispensary"
Address:
City:
Barnaul
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Sergei A Kolomiets
Phone:
+7 (385) 250 73 55
Email:
akod@zdravalt.ru
Facility:
Name:
Limited Liability Company "EVIMED"
Address:
City:
Chelyabinsk
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Oleg A Gladkov
Phone:
+7 (351) 220 12 22
Email:
info@evimeds.ru
Facility:
Name:
Private healthcare institution "Clinical hospital "RZD-Medicine" of the city of Chelyabinsk"
Address:
City:
Chelyabinsk
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Olga V Kurchenkova
Phone:
+7 (351) 211 12 03
Email:
dkbsecr@dkb74.ru
Facility:
Name:
State budgetary healthcare institution Leningrad Regional Clinical Hospital
Address:
City:
Gatchina
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Mariia V Smagina
Phone:
+7 (812) 670 18 88
Email:
lokb@47lokb.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:
State budgetary health care institution "Kuzbass clinical oncological dispensary named after M.S. Rappoport"
Address:
City:
Kemerovo
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Artur Z Azanov
Phone:
+7 (3842) 54 14 98
Email:
05-guz-okod@kuzdrav.ru
Facility:
Name:
Regional Goverment Budgetary Healthcare State "Kostroma Oncology Center"
Address:
City:
Kostroma
Zip:
156005
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Vera A Vaschenko
Phone:
7 (4942) 37 37 37
Email:
biocad@biocad.ru
Facility:
Name:
State Budgetary Institution of Healthcare "Leningrad Regional Clinical Oncological Dispensary named after V.I. L.D. Romana"
Address:
City:
Kuz'molovskiy
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Igor O Belogortsev
Phone:
+7 (813) 697 39 52
Email:
onco@lokod.ru
Facility:
Name:
"Russian Cancer Research Center named after N.N. Blokhin "of the Ministry of Health of the Russian Federation
Address:
City:
Moscow
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Leo Demidov
Phone:
+74993241504
Facility:
Name:
Branch of Hadassah Medical LTD Limited Liability Company
Address:
City:
Moscow
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Igor A Utiashev
Phone:
+7 (495) 186 41 48
Email:
info@hadassah.moscow
Facility:
Name:
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)
Address:
City:
Moscow
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Elena V Poddubskaya
Phone:
+7 (499) 248 05 53
Email:
rektorat@sechenov.ru
Facility:
Name:
Joint Stock Company "K31 City"
Address:
City:
Moscow
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Elena F Satirova
Phone:
+7 (495) 324 10 92
Email:
media@k31.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 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 Facility "Clinical Diagnostics Center"
Address:
City:
Nizhny Novgorod
Zip:
603006
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Irina S Shumskaya
Phone:
+7 (831) 282 00 01
Email:
sekretar@nnood.ru
Facility:
Name:
LLC "DobroMed"
Address:
City:
Novosibirsk
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Artem A Zeidlits
Phone:
+7 (383) 209 21 00
Email:
biocad@biocad.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:
Federal State Budgetary Institution "National Medical Research Center for Radiology" of the Ministry of Health of the Russian Federation
Address:
City:
Obninsk
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Natalia A Falaleeva
Phone:
+7 (495) 150 11 22
Email:
mrrc@mrrc.obninsk.ru
Facility:
Name:
Budgetary Healthcare Institution of Omsk Region "Clinical Oncology Center"
Address:
City:
Omsk
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Anastasiya V Zimina
Phone:
+7 (3812) 60 16 95
Email:
biocad@biocad.ru
Facility:
Name:
Federal State Budgetary Institution "National Medical Research Center of Oncology named after N.N. Petrov" of the Ministry of Health of the Russian Federation (FSBI "N.N. Petrov National Medical Research Center of Oncology" of the Ministry of Health of Ru
Address:
City:
Pesochnyy
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Svetlana A Protsenko
Phone:
+7 (812) 43 99 555
Email:
oncl@rion.spb.ru
Facility:
Name:
LLC "Clinical Trials"
Address:
City:
Saint Petersburg
Zip:
188663
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Igor O Belogortsev
Phone:
+7 (911) 218 59 27
Email:
biocad@biocad.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)-380-49-34
Email:
biocad@biocad.ru
Facility:
Name:
Federal State Budgetary Educational Institution of Higher Education "Saint Petersburg State University"
Address:
City:
Saint Petersburg
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Julia V Semiletova
Phone:
+7 (812) 328 20 00
Email:
spbu@spbu.ru
Facility:
Name:
Federal State Budgetary Health Institution St. Petersburg Clinical Hospital of the Russian Academy of Sciences
Address:
City:
Saint Petersburg
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Ivan V Rikov
Phone:
+7 (812) 222 22 72
Email:
hospital@spbkbran.ru
Facility:
Name:
Limited Liability Company "EuroCityClinic"
Address:
City:
Saint Petersburg
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Sergei V Orlov
Phone:
+7 (812) 618 08 00
Email:
info@eurocityclinic.ru
Facility:
Name:
Limited Liability Company "Oncological Research Center"
Address:
City:
Saint Petersburg
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Timur T Agishev
Phone:
+7 (812) 409 96 63
Email:
reception@spbonc.ru
Facility:
Name:
Limited Liability Company "Stepmed Clinic"
Address:
City:
Saint Petersburg
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Andrei V Kutkovich
Phone:
+7 (812) 219 50 27
Email:
clinic@step-med.com
Facility:
Name:
Limited Liability Company "Strategic Medical Systems"
Address:
City:
Saint Petersburg
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Ivan S Sardaryan
Phone:
+7 (921) 300 86 18
Email:
info@mt.clinic
Facility:
Name:
LLC "AV medical group"
Address:
City:
Saint Petersburg
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Timur T Andabekov, PhD in Medicine
Phone:
+7 (921) 907 71 57
Email:
biocad@biocad.ru
Facility:
Name:
N.N. Petrov National Medicine Research Center of oncology
Address:
City:
Saint Petersburg
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Artem N Poltoratski
Phone:
+7 (812) 439 95 55
Email:
oncl@rion.spb.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) 644 10 27
Email:
emeds.spb@yandex.ru
Facility:
Name:
Private institution educational organization of higher education "Medical University "Reaviz"
Address:
City:
Samara
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Mikhail V Kopp
Phone:
+7 (800) 600 24 00
Email:
mail@reaviz.ru
Facility:
Name:
State budgetary health care institution "St. Petersburg Clinical Scientific and Practical Center of Specialized Medical Assistance (Oncological)"
Address:
City:
Sankt Petersburg
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Vladimir Moiseenko, MD
Phone:
+78125739191
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
Facility:
Name:
Oncology Dispensary 2
Address:
City:
Sochi
Zip:
354057
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
DmitriI V Kirtbaya
Phone:
+7 (862) 261 43 93
Email:
onko13@sochi.com
Facility:
Name:
City Hospital #40, Kurortny district
Address:
City:
St. Petersburg
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Dmitrii V Gladishev
Phone:
+7 (812) 437 46 18
Email:
b40@zdrav.spb.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
Facility:
Name:
State Regional Budgetary Healthcare Institution "Regional Clinical Oncology Hospital" of the Yaroslavl Region
Address:
City:
Yaroslavl
Zip:
150054
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Nikolay V Kislov
Phone:
+7(4852) 208 100
Email:
yar_okob@mail.ru
Start date:
August 2, 2022
Completion date:
April 2025
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/NCT05732805
