search
Back to results

A Study of Neoadjuvant Therapy With BCD-217 (Nurulimab + Prolgolimab) in Patients With Resectable Stage III Skin Melanoma (NEO-MIMAJOR)

Primary Purpose

Melanoma Stage III, Melanoma (Skin)

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
BCD-217
anti-PD1
Excision of the primary lesion
Regional lymphadenectomy
Sponsored by
Biocad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

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 or cytologically confirmed (documented results of relevant studies are available) resectable stage IIIB/C/D skin melanoma; At least one clinically detectable lymph node accessible for biopsy and not more than three resectable in-transit metastases . Clinically detectable lymph nodes include: Palpable lymph nodes with pathologically confirmed melanoma Non-palpable but enlarged (≥15 mm in smallest diameter, RECIST 1.1) lymph nodes with pathologically confirmed melanoma Subject's consent to a biopsy; Consent to the evaluation of the PD-L1 status and BRAF V600 mutation status ; ECOG score 0-1; Life expectancy of at least 5 years; Willingness of subjects and their sexual partners of childbearing potential to use reliable methods of contraception from the date of signing the informed consent form throughout the study period and for 24 weeks after the administration of the last dose of the investigational therapy. Exclusion Criteria: Ocular melanoma; Mucosal melanoma; Distant metastases; Impossibility of radical resection of the tumor, metastasis and/or involved lymph nodes; Presence of only in-transit transit/satellite metastases without confirmed involvement of lymph nodes; 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; Prior radiation therapy; Inability to determine BRAF status; Subjects with severe comorbidities, with life-threatening acute complications of the underlying disease at the time of signing the informed consent form; Current concomitant diseases at the time of screening, which increase the risk of severe adverse events during surgery and/or study therapy administration; 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 cardiac failure (NYHA classes III and IV); uncontrolled hypertension (systolic blood pressure >150 mmHg or diastolic blood pressure >90 mmHg) ; a history of atopic asthma , angioneurotic edema; 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 surgery or study therapy; Known or suspected systemic autoimmune diseases (including, but not limited to, systemic lupus erythematosus, Crohn's disease, ulcerative colitis (UC), systemic scleroderma, inflammatory myopathy, mixed connective tissue disease, overlap syndrome, etc.) ; A history of interstitial pulmonary disease or pneumonitis requiring systemic glucocorticoids; The need for glucocorticoid therapy (at >10mg/day prednisolone equivalent doses) or any other drugs with immunosuppressive effects within 6 months prior to randomization; Use of immunostimulants, monoclonal antibodies and/or colony-stimulating factors within less than 4 weeks prior to randomization in the study; Hematological abnormalities : neutrophils <1.5×109/L; platelets <100×109/L; hemoglobin <90 g/L; Renal impairment: creatinine ≥1.5×ULN; Hepatic impairment : Total bilirubin ≥1.3×ULN (except for subjects with Gilbert's syndrome, in whom bilirubin levels should not exceed 50 μmol/L); ALP, AST or ALT ≥1.5×ULN; Any surgery within less than 28 days prior to randomization in 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), 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-217, prolgolimab or pembrolizumab; A history of hypersensitivity to monoclonal antibody products; Pregnancy or breastfeeding.

Sites / Locations

  • 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
  • Clinical Oncologic Dispensary No. 1Recruiting
  • Clinical Oncologic Dispensary No. 2Recruiting
  • Regional Clinical Oncology HospitalRecruiting
  • State Budgetary Healthcare Institution "Chelyabinsk Regional Clinical Center for Oncology and Nuclear Medicine",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
  • 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 the Omsk region "Clinical oncological dispensary"Recruiting
  • JSC "Modern Medical Technologies"Recruiting
  • Saint-Petersburg Petersburg Clinical Scientific and Practical Center for Specialized Types of Medical Care (Oncological)Recruiting
  • Federal State Budgetary Educational Institution of Higher Education "Saint Petersburg State University"Recruiting
  • Limited Liability Company "American Medical Clinic"Recruiting
  • Limited Liability Company "Oncological Research Center"Recruiting
  • Limited Liability Company "Strategic Medical Systems"Recruiting
  • N.N. Petrov National Medicine Research Center of oncologyRecruiting
  • Private Medical Institution EvromedservisRecruiting
  • Federal State Educational Institution of Higher Professional Education "Mordovia State University N.P. Ogareva "Recruiting
  • City Hospital #40, Kurortny districtRecruiting
  • State Health Care Institution "Volgograd Regional Clinical Oncology Dispensary № 1"Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Subjects with pCR and pnCR (Group 1A)

Subjects with a pPR or pNR to neoadjuvant therapy (Group 1B)

Control Group (Group 2)

Arm Description

Subjects will receive 2 cycles of BCD-217 neoadjuvant therapy, followed by index lymph node removal. Subjects with pathological complete (pCR) and near complete response (pnCR) (Group 1A): excision of the primary lesion (if not previously performed) without regional lymphadenectomy, followed by up to 12 months of anti-PD1 agent in the adjuvant setting.

Subjects will receive 2 cycles of BCD-217 neoadjuvant therapy, followed by index lymph node removal. Subjects with a pathological partial response (pPR) or non-responders (pNR) to neoadjuvant therapy (Group 1B): excision of the primary lesion (if not performed earlier), regional lymphadenectomy, then up to 12 months of adjuvant therapy with anti-PD1 agent.

Subjects start treatment with excision of the primary lesion (if not previously performed), regional lymphadenectomy followed by adjuvant therapy with anti-PD1 agent (up to 12 months). This approach is considered the standard therapy for patients in the target population.

Outcomes

Primary Outcome Measures

event free survival (EFS)

Secondary Outcome Measures

overall survival (OS)
distant metastases-free survival (DMFS)
pathologic response rate (pRR)
The proportion of subjects with treatment-related adverse events;
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 (grade 3 or higher according to CTCAE v.5.0)
The proportion of subjects requiring treatment discontinuation due to AEs
The proportion of BAb and NAb positive subjects

Full Information

First Posted
February 21, 2023
Last Updated
March 13, 2023
Sponsor
Biocad
search

1. Study Identification

Unique Protocol Identification Number
NCT05751928
Brief Title
A Study of Neoadjuvant Therapy With BCD-217 (Nurulimab + Prolgolimab) in Patients With Resectable Stage III Skin Melanoma
Acronym
NEO-MIMAJOR
Official Title
A Randomized Study of the Efficacy and Safety of Neoadjuvant Therapy With BCD-217 (Nurulimab + Prolgolimab) Versus Standard Adjuvant Therapy With Pembrolizumab in Patients With Resectable Stage III Skin Melanoma.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 2023 (Anticipated)
Primary Completion Date
January 2027 (Anticipated)
Study Completion Date
June 2027 (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
Yes

5. Study Description

Brief Summary
This study is an open-label, randomized, comparative phase III study, which will include subjects with resectable stage III skin melanoma (up to 3 resectable transient metastases are acceptable).
Detailed Description
In both study groups, adjuvant therapy is possible until melanoma progresses to unresectable stage III-IV, unacceptable toxicity, withdrawal of ICF or the end of the therapy period (12 months). In case of postoperative relapse of the disease, at the decision of the investigator and if the lesion is resectable, radical surgical treatment can be carried out (R0 - resection) in accordance with current clinical guidelines without withdrawing the patient from the study.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
410 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Subjects with pCR and pnCR (Group 1A)
Arm Type
Experimental
Arm Description
Subjects will receive 2 cycles of BCD-217 neoadjuvant therapy, followed by index lymph node removal. Subjects with pathological complete (pCR) and near complete response (pnCR) (Group 1A): excision of the primary lesion (if not previously performed) without regional lymphadenectomy, followed by up to 12 months of anti-PD1 agent in the adjuvant setting.
Arm Title
Subjects with a pPR or pNR to neoadjuvant therapy (Group 1B)
Arm Type
Experimental
Arm Description
Subjects will receive 2 cycles of BCD-217 neoadjuvant therapy, followed by index lymph node removal. Subjects with a pathological partial response (pPR) or non-responders (pNR) to neoadjuvant therapy (Group 1B): excision of the primary lesion (if not performed earlier), regional lymphadenectomy, then up to 12 months of adjuvant therapy with anti-PD1 agent.
Arm Title
Control Group (Group 2)
Arm Type
Active Comparator
Arm Description
Subjects start treatment with excision of the primary lesion (if not previously performed), regional lymphadenectomy followed by adjuvant therapy with anti-PD1 agent (up to 12 months). This approach is considered the standard therapy for patients in the target population.
Intervention Type
Biological
Intervention Name(s)
BCD-217
Other Intervention Name(s)
nurulimab+prolgolimab
Intervention Description
BCD-217 (anti-CTLA4 agent nurulimab + anti-PD1) once every 3 weeks in the neoadjuvant setting
Intervention Type
Biological
Intervention Name(s)
anti-PD1
Intervention Description
anti-PD1 agent in the adjuvant setting
Intervention Type
Procedure
Intervention Name(s)
Excision of the primary lesion
Intervention Description
Excision of the primary lesion will be performed per standard of care.
Intervention Type
Procedure
Intervention Name(s)
Regional lymphadenectomy
Intervention Description
Regional lymphadenectomy will be performed per standard of care.
Primary Outcome Measure Information:
Title
event free survival (EFS)
Time Frame
24 months
Secondary Outcome Measure Information:
Title
overall survival (OS)
Time Frame
24 months
Title
distant metastases-free survival (DMFS)
Time Frame
24 months
Title
pathologic response rate (pRR)
Time Frame
24 months
Title
The proportion of subjects with treatment-related adverse events;
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 (grade 3 or higher according to CTCAE v.5.0)
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

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 or cytologically confirmed (documented results of relevant studies are available) resectable stage IIIB/C/D skin melanoma; At least one clinically detectable lymph node accessible for biopsy and not more than three resectable in-transit metastases . Clinically detectable lymph nodes include: Palpable lymph nodes with pathologically confirmed melanoma Non-palpable but enlarged (≥15 mm in smallest diameter, RECIST 1.1) lymph nodes with pathologically confirmed melanoma Subject's consent to a biopsy; Consent to the evaluation of the PD-L1 status and BRAF V600 mutation status ; ECOG score 0-1; Life expectancy of at least 5 years; Willingness of subjects and their sexual partners of childbearing potential to use reliable methods of contraception from the date of signing the informed consent form throughout the study period and for 24 weeks after the administration of the last dose of the investigational therapy. Exclusion Criteria: Ocular melanoma; Mucosal melanoma; Distant metastases; Impossibility of radical resection of the tumor, metastasis and/or involved lymph nodes; Presence of only in-transit transit/satellite metastases without confirmed involvement of lymph nodes; 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; Prior radiation therapy; Inability to determine BRAF status; Subjects with severe comorbidities, with life-threatening acute complications of the underlying disease at the time of signing the informed consent form; Current concomitant diseases at the time of screening, which increase the risk of severe adverse events during surgery and/or study therapy administration; 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 cardiac failure (NYHA classes III and IV); uncontrolled hypertension (systolic blood pressure >150 mmHg or diastolic blood pressure >90 mmHg) ; a history of atopic asthma , angioneurotic edema; 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 surgery or study therapy; Known or suspected systemic autoimmune diseases (including, but not limited to, systemic lupus erythematosus, Crohn's disease, ulcerative colitis (UC), systemic scleroderma, inflammatory myopathy, mixed connective tissue disease, overlap syndrome, etc.) ; A history of interstitial pulmonary disease or pneumonitis requiring systemic glucocorticoids; The need for glucocorticoid therapy (at >10mg/day prednisolone equivalent doses) or any other drugs with immunosuppressive effects within 6 months prior to randomization; Use of immunostimulants, monoclonal antibodies and/or colony-stimulating factors within less than 4 weeks prior to randomization in the study; Hematological abnormalities : neutrophils <1.5×109/L; platelets <100×109/L; hemoglobin <90 g/L; Renal impairment: creatinine ≥1.5×ULN; Hepatic impairment : Total bilirubin ≥1.3×ULN (except for subjects with Gilbert's syndrome, in whom bilirubin levels should not exceed 50 μmol/L); ALP, AST or ALT ≥1.5×ULN; Any surgery within less than 28 days prior to randomization in 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), 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-217, prolgolimab or pembrolizumab; A history of hypersensitivity to monoclonal antibody products; Pregnancy or breastfeeding.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fedor B Kriukov, MD PhD
Phone
+7 (812) 380 49 33
Email
biocad@biocad.ru
First Name & Middle Initial & Last Name or Official Title & Degree
Anna A Siliutina, MD PhD
Phone
+7 (812) 380 49 33
Email
biocad@biocad.ru
Facility Information:
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
Clinical Oncologic Dispensary No. 1
City
Krasnodar
State/Province
Krasnodar Kari
ZIP/Postal Code
350040
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julia M Makarova, MD
Phone
+7-(812)-380-49-34
Email
biocad@biocad.ru
Facility Name
Clinical Oncologic Dispensary No. 2
City
Sochi
State/Province
Krasnodar Territory
ZIP/Postal Code
354057
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dmitry V Kirtbaya, MD
Phone
+7 (862) 261 43 89
Email
biocad@biocad.ru
Facility Name
Regional Clinical Oncology Hospital
City
Yaroslavl
State/Province
Yaroslavskaya Oblast
ZIP/Postal Code
150054
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nikolay V Kislov, MD, PhD
Phone
+7-(812)-380-49-34
Email
biocad@biocad.ru
Facility Name
State Budgetary Healthcare Institution "Chelyabinsk Regional Clinical Center for Oncology and Nuclear Medicine",
City
Chelyabinsk
ZIP/Postal Code
454087
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natalya V Fadeeva, PhD in Medicine
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
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 the Omsk region "Clinical oncological dispensary"
City
Omsk
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anastasiia V Zimina
Phone
+7 (3812) 60 16 95
Email
omonkol_mail@minzdrav.omskportal.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
Saint-Petersburg Petersburg Clinical Scientific and Practical Center for Specialized Types of Medical Care (Oncological)
City
Saint Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vladimir M Moiseenko, MD, PhD
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
Limited Liability Company "American Medical 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) 740 20 90
Email
info@amclinic.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 Andabecov
Phone
+7 (812) 409 96 63
Email
reception@spbonc.ru
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
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
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
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

12. IPD Sharing Statement

Learn more about this trial

A Study of Neoadjuvant Therapy With BCD-217 (Nurulimab + Prolgolimab) in Patients With Resectable Stage III Skin Melanoma

We'll reach out to this number within 24 hrs