search
Back to results

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 (OCTAVA)

Primary Purpose

Melanoma, Melanoma (Skin), Melanoma Stage III

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
BCD-217
BCD-100
Placebo
Sponsored by
Biocad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma focused on measuring PD-1, CTLA-4, prolgolimab, nurulimab, immunotherapy, checkpoint inhibitors, CPI, programm death, cytotoxic T-lymphocyte-associated protein

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Signed informed consent and the subject's ability to comply with the requirements of the clinical study protocol; Age ≥18 years at the time of signing the informed consent form; Histologically confirmed melanoma (with available documented evidence of relevant investigations); Untreated unresectable stage III melanoma or untreated metastatic (stage IV) melanoma; Available blocks for histological examination and/or the subject's consent to undergo biopsy ; Consent to the evaluation of the PD-L1 status and BRAF V600 mutation status at a central laboratory; ECOG score 0-1; Life expectancy of at least 12 weeks ; Measurable target tumor lesions (at least 1 lesion) according to RECIST 1.1 criteria , confirmed by central independent reviewer; 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: Indications for radical (surgical, radiation) therapy; A history of previous systemic antitumor therapy for unresectable or metastatic melanoma ; Prior therapy with checkpoint inhibitors (e.g., anti-CTLA-4 and/or anti-PD-1/PD-L1/PD-L2 products); Prior therapy with BRAF and MEK protein kinase inhibitors; Use of immunostimulants, monoclonal antibodies and/or colony-stimulating factors within less than 4 weeks prior to randomization in the study; Ocular melanoma; Mucosal melanoma; CNS metastases; Impossibility to determine PD-L1 status and/or BRAF status; 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; 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; 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.) ; History of interstitial pulmonary disease or pneumonitis requiring systemic glucocorticoids; 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; Hematologic abnormalities : neutrophils <1.5×109/L; platelets <100×109/L; hemoglobin <90 g/L; Renal impairment: creatinine ≥2.5×ULN; 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); Any antitumor treatment within less than 4 weeks or surgery within less than 28 days prior to randomization within the study; History of oncological disease, except for radically treated diseases with remission for over 5 years prior randomization in this study ; Conditions limiting the subject's ability to comply with the Protocol requirements (in the Investigator's opinion ); Participation in other clinical studies within less than 30 days prior to randomization and during this clinical study ; Acute infections or activation of chronic infectious diseases or systemic antibacterial therapy within less than 28 days prior to randomization; Active hepatitis B, active hepatitis C (confirmed by PCR), active syphilis, HIV-infection, currently or previously ; Impossibility to administer the investigational product intravenously; Impossibility to administer intravenous contrast agents (including due to hypersensitivity to contrast media); Hypersensitivity to any of the components of BCD-100 or BCD-217; A history of hypersensitivity to monoclonal antibody products; Pregnancy or breastfeeding.

Sites / Locations

  • Healthcare Institution "Bobruisk Interdistrict Oncological Dispensary"Recruiting
  • Healthcare Institution "Brest Regional Oncological Dispensary"Recruiting
  • Health Institution "Gomel Regional Clinical Oncology Center"Recruiting
  • Health care institution "Grodno University Clinic"Recruiting
  • State Institution "Republican Scientific and Practical Center of Oncology and Medical Radiology named after A.I. N.N. Alexandrov"Recruiting
  • Healthcare Institution "Minsk City Clinical Cancer Center"Recruiting
  • State Institution "Mogilev Regional Oncological Dispensary"Recruiting
  • Healthcare Institution "Vitebsk Regional Clinical Oncology Center"Recruiting
  • Fortis HospitalRecruiting
  • Kasturba Medical College and HospitalRecruiting
  • TATA Memorial HospitalRecruiting
  • HealthCare Global Enterprises Ltd, NCHRI Cancer CenterRecruiting
  • HealthCare Global Enterprises Ltd Manavata cancer CentreRecruiting
  • Sankalp Superspeciality HospitalRecruiting
  • All India Institute of Medical ScienceRecruiting
  • Deenanath Mangeshkar Hospital & Research CenterRecruiting
  • PDEAS Ayurved Rugnalaya & Steriling Multispeciality HospitalRecruiting
  • Horizon Mulitispeciality HospitalRecruiting
  • Shalby HospitalRecruiting
  • Kiran Multispeciality hospital &ResearchRecruiting
  • Chelyabinsk Regional Clinical Center for Oncology and Nuclear MedicineRecruiting
  • LLC "New Clinic"Recruiting
  • Arkhangelsk Clinical Oncology DispensaryRecruiting
  • Regional State Budgetary Institution of Health Care "Altai Regional Oncological Dispensary"Recruiting
  • Limited Liability Company "EVIMED"Recruiting
  • Private healthcare institution "Clinical hospital "RZD-Medicine" of the city of Chelyabinsk"Recruiting
  • State budgetary healthcare institution Leningrad Regional Clinical HospitalRecruiting
  • State Autonomous Health Institution "Republican Clinical Oncology Dispensary of the Ministry of Health of the Republic of Tatarstan named after Professor M.Z. Sigal"Recruiting
  • State budgetary health care institution "Kuzbass clinical oncological dispensary named after M.S. Rappoport"Recruiting
  • Regional Goverment Budgetary Healthcare State "Kostroma Oncology Center"Recruiting
  • State Budgetary Institution of Healthcare "Leningrad Regional Clinical Oncological Dispensary named after V.I. L.D. Romana"Recruiting
  • "Russian Cancer Research Center named after N.N. Blokhin "of the Ministry of Health of the Russian FederationRecruiting
  • Branch of Hadassah Medical LTD Limited Liability CompanyRecruiting
  • 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)Recruiting
  • Joint Stock Company "K31 City"Recruiting
  • JSC "Medsi Group"Recruiting
  • Moscow City Oncology Hospital No. 62Recruiting
  • 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"Recruiting
  • 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"Recruiting
  • Nizhny Novgorod Region State Budgetary Healthcare Facility "Clinical Diagnostics Center"Recruiting
  • LLC "DobroMed"Recruiting
  • State Budgetary Healthcare Institution "Novosibirsk Regional Clinical Oncology Center" of the Novosibirsk RegionRecruiting
  • Federal State Budgetary Institution "National Medical Research Center for Radiology" of the Ministry of Health of the Russian FederationRecruiting
  • Budgetary Healthcare Institution of Omsk Region "Clinical Oncology Center"Recruiting
  • 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 RuRecruiting
  • LLC "Clinical Trials"Recruiting
  • JSC "Modern Medical Technologies"Recruiting
  • Federal State Budgetary Educational Institution of Higher Education "Saint Petersburg State University"Recruiting
  • Federal State Budgetary Health Institution St. Petersburg Clinical Hospital of the Russian Academy of SciencesRecruiting
  • Limited Liability Company "EuroCityClinic"Recruiting
  • Limited Liability Company "Oncological Research Center"Recruiting
  • Limited Liability Company "Stepmed Clinic"Recruiting
  • Limited Liability Company "Strategic Medical Systems"Recruiting
  • LLC "AV medical group"Recruiting
  • N.N. Petrov National Medicine Research Center of oncologyRecruiting
  • Private Medical Institution EvromedservisRecruiting
  • Private institution educational organization of higher education "Medical University "Reaviz"Recruiting
  • State budgetary health care institution "St. Petersburg Clinical Scientific and Practical Center of Specialized Medical Assistance (Oncological)"Recruiting
  • Federal State Educational Institution of Higher Professional Education "Mordovia State University N.P. Ogareva "Recruiting
  • Oncology Dispensary 2Recruiting
  • City Hospital #40, Kurortny districtRecruiting
  • State Health Care Institution "Volgograd Regional Clinical Oncology Dispensary № 1"Recruiting
  • State Regional Budgetary Healthcare Institution "Regional Clinical Oncology Hospital" of the Yaroslavl RegionRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BCD-217 (nurulimab + prolgolimab)

BCD-100 (prolgolimab)

Arm Description

BCD-217 followed by prolgolimab 1 mg/kg monotherapy.

Prolgolimab monotherapy.

Outcomes

Primary Outcome Measures

Progression-free survival

Secondary Outcome Measures

Overall survival
Overall response rate (partial response + complete response rate)
Disease control rate (stable disease + partial response + complete response rate)
Time to response
Duration of response
The proportion of subjects experiencing adverse events related to study therapy
The proportion of subjects experiencing any grade 3 or higher adverse events
The proportion of subjects with SAEs
The proportion of subjects with immune-related adverse events of any severity
The proportion of subjects with severe immune-related adverse events
The proportion of subjects requiring treatment discontinuation due to AEs
The proportion of BAb and NAb positive subjects
Ctrough (plasma concentration of anti-PD-1/CTLA-4 monoclonal antibody measured at the end of the dosing interval before the next dose)

Full Information

First Posted
February 8, 2023
Last Updated
February 8, 2023
Sponsor
Biocad
search

1. Study Identification

Unique Protocol Identification Number
NCT05732805
Brief 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
Acronym
OCTAVA
Official Title
A Double-Blind Placebo-Controlled Comparative Randomized Clinical Study of the Efficacy and Safety 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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 2, 2022 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biocad

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma, Melanoma (Skin), Melanoma Stage III, Melanoma Stage IV, Melanoma Unresectable, Melanoma Metastatic, Melanoma Advanced
Keywords
PD-1, CTLA-4, prolgolimab, nurulimab, immunotherapy, checkpoint inhibitors, CPI, programm death, cytotoxic T-lymphocyte-associated protein

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
270 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BCD-217 (nurulimab + prolgolimab)
Arm Type
Experimental
Arm Description
BCD-217 followed by prolgolimab 1 mg/kg monotherapy.
Arm Title
BCD-100 (prolgolimab)
Arm Type
Active Comparator
Arm Description
Prolgolimab monotherapy.
Intervention Type
Biological
Intervention Name(s)
BCD-217
Other Intervention Name(s)
nurulimab+prolgolimab
Intervention 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).
Intervention Type
Biological
Intervention Name(s)
BCD-100
Other Intervention Name(s)
prolgolimab, Forteca
Intervention 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).
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Progression-free survival
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
24 months
Title
Overall response rate (partial response + complete response rate)
Time Frame
24 months
Title
Disease control rate (stable disease + partial response + complete response rate)
Time Frame
24 months
Title
Time to response
Time Frame
24 months
Title
Duration of response
Time Frame
24 months
Title
The proportion of subjects experiencing adverse events related to study therapy
Time Frame
24 months
Title
The proportion of subjects experiencing any grade 3 or higher adverse events
Time Frame
24 months
Title
The proportion of subjects with SAEs
Time Frame
24 months
Title
The proportion of subjects with immune-related adverse events of any severity
Time Frame
24 months
Title
The proportion of subjects with severe immune-related adverse events
Time Frame
24 months
Title
The proportion of subjects requiring treatment discontinuation due to AEs
Time Frame
24 months
Title
The proportion of BAb and NAb positive subjects
Time Frame
24 months
Title
Ctrough (plasma concentration of anti-PD-1/CTLA-4 monoclonal antibody measured at the end of the dosing interval before the next dose)
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed informed consent and the subject's ability to comply with the requirements of the clinical study protocol; Age ≥18 years at the time of signing the informed consent form; Histologically confirmed melanoma (with available documented evidence of relevant investigations); Untreated unresectable stage III melanoma or untreated metastatic (stage IV) melanoma; Available blocks for histological examination and/or the subject's consent to undergo biopsy ; Consent to the evaluation of the PD-L1 status and BRAF V600 mutation status at a central laboratory; ECOG score 0-1; Life expectancy of at least 12 weeks ; Measurable target tumor lesions (at least 1 lesion) according to RECIST 1.1 criteria , confirmed by central independent reviewer; 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: Indications for radical (surgical, radiation) therapy; A history of previous systemic antitumor therapy for unresectable or metastatic melanoma ; Prior therapy with checkpoint inhibitors (e.g., anti-CTLA-4 and/or anti-PD-1/PD-L1/PD-L2 products); Prior therapy with BRAF and MEK protein kinase inhibitors; Use of immunostimulants, monoclonal antibodies and/or colony-stimulating factors within less than 4 weeks prior to randomization in the study; Ocular melanoma; Mucosal melanoma; CNS metastases; Impossibility to determine PD-L1 status and/or BRAF status; 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; 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; 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.) ; History of interstitial pulmonary disease or pneumonitis requiring systemic glucocorticoids; 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; Hematologic abnormalities : neutrophils <1.5×109/L; platelets <100×109/L; hemoglobin <90 g/L; Renal impairment: creatinine ≥2.5×ULN; 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); Any antitumor treatment within less than 4 weeks or surgery within less than 28 days prior to randomization within the study; History of oncological disease, except for radically treated diseases with remission for over 5 years prior randomization in this study ; Conditions limiting the subject's ability to comply with the Protocol requirements (in the Investigator's opinion ); Participation in other clinical studies within less than 30 days prior to randomization and during this clinical study ; Acute infections or activation of chronic infectious diseases or systemic antibacterial therapy within less than 28 days prior to randomization; Active hepatitis B, active hepatitis C (confirmed by PCR), active syphilis, HIV-infection, currently or previously ; Impossibility to administer the investigational product intravenously; Impossibility to administer intravenous contrast agents (including due to hypersensitivity to contrast media); Hypersensitivity to any of the components of BCD-100 or BCD-217; A history of hypersensitivity to monoclonal antibody products; Pregnancy or breastfeeding.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anna A Siliutina, MD PhD
Phone
+7 (812) 380 49 33
Email
siljutina@biocad.ru
First Name & Middle Initial & Last Name or Official Title & Degree
Fedor B Kriukov, MD PhD
Phone
+7 (812) 380 49 33
Email
kryukov@biocad.ru
Facility Information:
Facility Name
Healthcare Institution "Bobruisk Interdistrict Oncological Dispensary"
City
Babruysk
Country
Belarus
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Igor A Sharf
Phone
+375225 736262
Email
uz@bmod.by
Facility Name
Healthcare Institution "Brest Regional Oncological Dispensary"
City
Brest
Country
Belarus
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vitalii S Volkov
Phone
+375 (0162) 97-83-03
Email
biocad@biocad.ru
Facility Name
Health Institution "Gomel Regional Clinical Oncology Center"
City
Gomel
Country
Belarus
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vasilii N Belyakovskii
Phone
+7 (812) 380 49 33
Email
mail@gokod.by
Facility Name
Health care institution "Grodno University Clinic"
City
Grodno
Country
Belarus
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
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"
City
Lesnoy
Country
Belarus
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nikolaii B Ermakov
Phone
(+375 17) 265-23-01
Email
oncobel@omr.med.by
Facility Name
Healthcare Institution "Minsk City Clinical Cancer Center"
City
Minsk
ZIP/Postal Code
220013
Country
Belarus
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Svetlana A Demidova
Phone
+375 17 237 32 90
Email
onko@mgkod.by
Facility Name
State Institution "Mogilev Regional Oncological Dispensary"
City
Mogilev
Country
Belarus
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natalia I Ivanova
Phone
+7 (812) 380 49 33
Email
info@mood.by
Facility Name
Healthcare Institution "Vitebsk Regional Clinical Oncology Center"
City
Vitebsk
Country
Belarus
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aleksei L Obukhov
Phone
+ 375 (212) 57-40-31
Email
biocad@biocad.ru
Facility Name
Fortis Hospital
City
Faridabad
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amit Bhargava, MD
Email
biocad@biocad.ru
Facility Name
Kasturba Medical College and Hospital
City
Mangalore
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
M S Athiyamaan, MD
Email
biocad@biocad.ru
Facility Name
TATA Memorial Hospital
City
Mumbai
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prabhat G Bhargava, MD
Email
biocad@biocad.ru
Facility Name
HealthCare Global Enterprises Ltd, NCHRI Cancer Center
City
Nagpur
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ajay O Mehta, MD
Email
biocad@biocad.ru
Facility Name
HealthCare Global Enterprises Ltd Manavata cancer Centre
City
Nashik
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rajnish Nagarkar, MD
Email
biocad@biocad.ru
Facility Name
Sankalp Superspeciality Hospital
City
Nashik
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bhushan Nemade, MD
Email
biocad@biocad.ru
Facility Name
All India Institute of Medical Science
City
New Delhi
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sameer Rastogi, MD
Email
biocad@biocad.ru
Facility Name
Deenanath Mangeshkar Hospital & Research Center
City
Pune
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chetanavata Deshmukh, MD
Email
biocad@biocad.ru
Facility Name
PDEAS Ayurved Rugnalaya & Steriling Multispeciality Hospital
City
Pune
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rakesh Neve, MD
Email
biocad@biocad.ru
Facility Name
Horizon Mulitispeciality Hospital
City
Sangli
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vaibhav Amale, MD
Email
biocad@biocad.ru
Facility Name
Shalby Hospital
City
Surat
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kaushal Patel, MD
Email
biocad@biocad.ru
Facility Name
Kiran Multispeciality hospital &Research
City
Sūrat
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anshul Agrawal, MD
Email
biocad@biocad.ru
Facility Name
Chelyabinsk Regional Clinical Center for Oncology and Nuclear Medicine
City
Chelyabinsk
State/Province
Chelyabinsk Oblast
ZIP/Postal Code
454087
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natalya V Fadeeva, MD, PhD
Phone
+7-(812)-380-49-34
Email
biocad@biocad.ru
Facility Name
LLC "New Clinic"
City
Pyatigorsk
State/Province
Stavropol Krai
ZIP/Postal Code
357500
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victoria V Chistyakova
Phone
+7 (8793) 97 45 31
Email
newclinic@list.ru
Facility Name
Arkhangelsk Clinical Oncology Dispensary
City
Arkhangel'sk
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
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"
City
Barnaul
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sergei A Kolomiets
Phone
+7 (385) 250 73 55
Email
akod@zdravalt.ru
Facility Name
Limited Liability Company "EVIMED"
City
Chelyabinsk
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
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"
City
Chelyabinsk
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olga V Kurchenkova
Phone
+7 (351) 211 12 03
Email
dkbsecr@dkb74.ru
Facility Name
State budgetary healthcare institution Leningrad Regional Clinical Hospital
City
Gatchina
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
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"
City
Kazan
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
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"
City
Kemerovo
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
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"
City
Kostroma
ZIP/Postal Code
156005
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
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"
City
Kuz'molovskiy
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
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
City
Moscow
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leo Demidov
Phone
+74993241504
Facility Name
Branch of Hadassah Medical LTD Limited Liability Company
City
Moscow
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
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)
City
Moscow
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elena V Poddubskaya
Phone
+7 (499) 248 05 53
Email
rektorat@sechenov.ru
Facility Name
Joint Stock Company "K31 City"
City
Moscow
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elena F Satirova
Phone
+7 (495) 324 10 92
Email
media@k31.ru
Facility Name
JSC "Medsi Group"
City
Moscow
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anastasiia S Mochalova
Phone
+7 (495) 021 47 02
Email
biocad@biocad.ru
Facility Name
Moscow City Oncology Hospital No. 62
City
Moscow
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
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"
City
Moscow
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
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"
City
Moscow
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
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"
City
Nizhny Novgorod
ZIP/Postal Code
603006
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Irina S Shumskaya
Phone
+7 (831) 282 00 01
Email
sekretar@nnood.ru
Facility Name
LLC "DobroMed"
City
Novosibirsk
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
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
City
Novosibirsk
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
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
City
Obninsk
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
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"
City
Omsk
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
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
City
Pesochnyy
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Svetlana A Protsenko
Phone
+7 (812) 43 99 555
Email
oncl@rion.spb.ru
Facility Name
LLC "Clinical Trials"
City
Saint Petersburg
ZIP/Postal Code
188663
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Igor O Belogortsev
Phone
+7 (911) 218 59 27
Email
biocad@biocad.ru
Facility Name
JSC "Modern Medical Technologies"
City
Saint Petersburg
ZIP/Postal Code
190013
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
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"
City
Saint Petersburg
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
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
City
Saint Petersburg
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ivan V Rikov
Phone
+7 (812) 222 22 72
Email
hospital@spbkbran.ru
Facility Name
Limited Liability Company "EuroCityClinic"
City
Saint Petersburg
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sergei V Orlov
Phone
+7 (812) 618 08 00
Email
info@eurocityclinic.ru
Facility Name
Limited Liability Company "Oncological Research Center"
City
Saint Petersburg
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Timur T Agishev
Phone
+7 (812) 409 96 63
Email
reception@spbonc.ru
Facility Name
Limited Liability Company "Stepmed Clinic"
City
Saint Petersburg
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrei V Kutkovich
Phone
+7 (812) 219 50 27
Email
clinic@step-med.com
Facility Name
Limited Liability Company "Strategic Medical Systems"
City
Saint Petersburg
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ivan S Sardaryan
Phone
+7 (921) 300 86 18
Email
info@mt.clinic
Facility Name
LLC "AV medical group"
City
Saint Petersburg
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
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
City
Saint Petersburg
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Artem N Poltoratski
Phone
+7 (812) 439 95 55
Email
oncl@rion.spb.ru
Facility Name
Private Medical Institution Evromedservis
City
Saint Petersburg
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
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"
City
Samara
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
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)"
City
Sankt Petersburg
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vladimir Moiseenko, MD
Phone
+78125739191
Facility Name
Federal State Educational Institution of Higher Professional Education "Mordovia State University N.P. Ogareva "
City
Saransk
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pavel Skopin, PhD
Facility Name
Oncology Dispensary 2
City
Sochi
ZIP/Postal Code
354057
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
DmitriI V Kirtbaya
Phone
+7 (862) 261 43 93
Email
onko13@sochi.com
Facility Name
City Hospital #40, Kurortny district
City
St. Petersburg
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
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"
City
Volgograd
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
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
City
Yaroslavl
ZIP/Postal Code
150054
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nikolay V Kislov
Phone
+7(4852) 208 100
Email
yar_okob@mail.ru

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs