Trial Title:
A Study of Neoadjuvant Therapy With BCD-217 (Nurulimab + Prolgolimab) in Patients With Resectable Stage III Skin Melanoma
NCT ID:
NCT05751928
Condition:
Melanoma Stage III
Melanoma (Skin)
Conditions: Official terms:
Melanoma
Conditions: Keywords:
PD-1
CTLA-4
prolgolimab
nurulimab
immunotherapy
checkpoint inhibitors
CPI
programm death
cytotoxic T-lymphocyte-associated protein
Neoadjuvant Melanoma
Adjuvant Melanoma
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
BCD-217
Description:
BCD-217 (anti-CTLA4 agent nurulimab + anti-PD1) once every 3 weeks in the neoadjuvant
setting
Arm group label:
Subjects with a pPR or pNR to neoadjuvant therapy (Group 1B)
Arm group label:
Subjects with pCR and pnCR (Group 1A)
Other name:
nurulimab+prolgolimab
Intervention type:
Biological
Intervention name:
anti-PD1
Description:
anti-PD1 agent in the adjuvant setting
Arm group label:
Subjects with a pPR or pNR to neoadjuvant therapy (Group 1B)
Arm group label:
Subjects with pCR and pnCR (Group 1A)
Intervention type:
Procedure
Intervention name:
Excision of the primary lesion
Description:
Excision of the primary lesion will be performed per standard of care.
Arm group label:
Control Group (Group 2)
Arm group label:
Subjects with a pPR or pNR to neoadjuvant therapy (Group 1B)
Arm group label:
Subjects with pCR and pnCR (Group 1A)
Intervention type:
Procedure
Intervention name:
Regional lymphadenectomy
Description:
Regional lymphadenectomy will be performed per standard of care.
Arm group label:
Control Group (Group 2)
Arm group label:
Subjects with a pPR or pNR to neoadjuvant therapy (Group 1B)
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.
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 or cytologically confirmed (documented results of relevant studies
are available) resectable stage IIIB/C/D skin melanoma;
4. 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
5. Subject's consent to a biopsy;
6. Consent to the evaluation of the PD-L1 status and BRAF V600 mutation status ;
7. ECOG score 0-1;
8. Life expectancy of at least 5 years;
9. 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:
1. Ocular melanoma;
2. Mucosal melanoma;
3. Distant metastases;
4. Impossibility of radical resection of the tumor, metastasis and/or involved lymph
nodes;
5. Presence of only in-transit transit/satellite metastases without confirmed
involvement of lymph nodes;
6. Prior therapy with checkpoint inhibitors (e.g. anti-CTLA-4 and/or
anti-PD-1/PD-L1/PD-L2 products);
7. Prior therapy with BRAF and MEK protein kinase inhibitors;
8. Prior radiation therapy;
9. Inability to determine BRAF status;
10. Subjects with severe comorbidities, with life-threatening acute complications of the
underlying disease at the time of signing the informed consent form;
11. 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;
12. 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.) ;
13. A history of interstitial pulmonary disease or pneumonitis requiring systemic
glucocorticoids;
14. The need for glucocorticoid therapy (at >10mg/day prednisolone equivalent doses) or
any other drugs with immunosuppressive effects within 6 months prior to
randomization;
15. Use of immunostimulants, monoclonal antibodies and/or colony-stimulating factors
within less than 4 weeks prior to randomization in the study;
16. Hematological abnormalities :
- neutrophils <1.5×109/L;
- platelets <100×109/L;
- hemoglobin <90 g/L;
17. Renal impairment: creatinine ≥1.5×ULN;
18. 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;
19. Any surgery within less than 28 days prior to randomization in the study;
20. History of oncological disease, except for radically treated diseases with remission
for over 5 years prior randomization in this study ;
21. Conditions limiting the subject's ability to comply with the Protocol requirements
(in the Investigator's opinion );
22. Participation in other clinical studies within less than 30 days prior to
randomization and during this clinical study ;
23. Acute infections or activation of chronic infectious diseases or systemic
antibacterial therapy within less than 28 days prior to randomization;
24. Active hepatitis B, active hepatitis C (confirmed by PCR), HIV-infection, currently
or previously ;
25. Impossibility to administer the investigational product intravenously;
26. Impossibility to administer intravenous contrast agents (including due to
hypersensitivity to contrast media);
27. Hypersensitivity to any of the components of BCD-217, prolgolimab or pembrolizumab;
28. A history of hypersensitivity to monoclonal antibody products;
29. Pregnancy or breastfeeding.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
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:
Clinical Oncologic Dispensary No. 1
Address:
City:
Krasnodar
Zip:
350040
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Julia M Makarova, MD
Phone:
+7-(812)-380-49-34
Email:
biocad@biocad.ru
Facility:
Name:
Clinical Oncologic Dispensary No. 2
Address:
City:
Sochi
Zip:
354057
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Dmitry V Kirtbaya, MD
Phone:
+7 (862) 261 43 89
Email:
biocad@biocad.ru
Facility:
Name:
Regional Clinical Oncology Hospital
Address:
City:
Yaroslavl
Zip:
150054
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
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",
Address:
City:
Chelyabinsk
Zip:
454087
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Natalya V Fadeeva, PhD in Medicine
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:
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 the Omsk region "Clinical oncological dispensary"
Address:
City:
Omsk
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Anastasiia V Zimina
Phone:
+7 (3812) 60 16 95
Email:
omonkol_mail@minzdrav.omskportal.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:
Saint-Petersburg Petersburg Clinical Scientific and Practical Center for Specialized Types of Medical Care (Oncological)
Address:
City:
Saint Petersburg
Zip:
197758
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Vladimir M Moiseenko, MD, PhD
Phone:
+7-(812)-380-49-34
Email:
biocad@biocad.ru
Facility:
Name:
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:
Limited Liability Company "American Medical Clinic"
Address:
City:
Saint Petersburg
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Andrei V Kutkovich
Phone:
+7 (812) 740 20 90
Email:
info@amclinic.ru
Facility:
Name:
Limited Liability Company "Oncological Research Center"
Address:
City:
Saint Petersburg
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Timur T Andabecov
Phone:
+7 (812) 409 96 63
Email:
reception@spbonc.ru
Facility:
Name:
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:
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:
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:
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
Start date:
March 2023
Completion date:
June 2027
Lead sponsor:
Agency:
Biocad
Agency class:
Industry
Source:
Biocad
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05751928
