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

Last Updated: 2025-02-27

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 270 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-02
• Study Completion Date: 2025-07-31

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)

Conditions

Melanoma; Melanoma (Skin); Melanoma Stage III; Melanoma Stage IV; Melanoma Unresectable; Melanoma Metastatic; Melanoma Advanced

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

BCD-217 (nurulimab + prolgolimab)

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

Group Type: EXPERIMENTAL

BCD-217

Intervention Type: BIOLOGICAL

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).

BCD-100

Intervention Type: BIOLOGICAL

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).

Placebo

Intervention Type: BIOLOGICAL

Placebo

BCD-100 (prolgolimab)

Prolgolimab monotherapy.

Group Type: ACTIVE_COMPARATOR

BCD-100

Intervention Type: BIOLOGICAL

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).

Placebo

Intervention Type: BIOLOGICAL

Placebo

Interventions

BCD-217

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

BCD-100

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

Placebo

Placebo

Intervention Type: BIOLOGICAL

Other Intervention Names

nurulimab+prolgolimab; prolgolimab; Forteca

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biocad

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Healthcare Institution "Bobruisk Interdistrict Oncological Dispensary"

Babruysk, , Belarus

Healthcare Institution "Brest Regional Oncological Dispensary"

Brest, , Belarus

Health care institution "Grodno University Clinic"

Grodno, , Belarus

Health Institution "Gomel Regional Clinical Oncology Center"

Homyel, , Belarus

State Institution "Republican Scientific and Practical Center of Oncology and Medical Radiology named after A.I. N.N. Alexandrov"

Lesnoy, , Belarus

Healthcare Institution "Minsk City Clinical Cancer Center"

Minsk, , Belarus

State Institution "Mogilev Regional Oncological Dispensary"

Mogilev, , Belarus

Healthcare Institution "Vitebsk Regional Clinical Oncology Center"

Vitebsk, , Belarus

Fortis Hospital

Faridabad, , India

Kasturba Medical College and Hospital

Mangalore, , India

TATA Memorial Hospital

Mumbai, , India

HealthCare Global Enterprises Ltd, NCHRI Cancer Center

Nagpur, , India

HealthCare Global Enterprises Ltd Manavata cancer Centre

Nashik, , India

Sankalp Superspeciality Hospital

Nashik, , India

All India Institute of Medical Science

New Delhi, , India

Deenanath Mangeshkar Hospital & Research Center

Pune, , India

PDEAS Ayurved Rugnalaya & Steriling Multispeciality Hospital

Pune, , India

Horizon Mulitispeciality Hospital

Sangli, , India

Shalby Hospital

Surat, , India

Kiran Multispeciality hospital &Research

Sūrat, , India

Chelyabinsk Regional Clinical Center for Oncology and Nuclear Medicine

Chelyabinsk, Chelyabinsk Oblast, Russia

LLC "New Clinic"

Pyatigorsk, Stavropol Kray, Russia

Arkhangelsk Clinical Oncology Dispensary

Arkhangelsk, , Russia

Regional State Budgetary Institution of Health Care "Altai Regional Oncological Dispensary"

Barnaul, , Russia

Limited Liability Company "EVIMED"

Chelyabinsk, , Russia

Private healthcare institution "Clinical hospital "RZD-Medicine" of the city of Chelyabinsk"

Chelyabinsk, , Russia

State budgetary healthcare institution Leningrad Regional Clinical Hospital

Gatchina, , Russia

State Autonomous Health Institution "Republican Clinical Oncology Dispensary of the Ministry of Health of the Republic of Tatarstan named after Professor M.Z. Sigal"

Kazan', , Russia

State budgetary health care institution "Kuzbass clinical oncological dispensary named after M.S. Rappoport"

Kemerovo, , Russia

Regional Goverment Budgetary Healthcare State "Kostroma Oncology Center"

Kostroma, , Russia

State Budgetary Institution of Healthcare "Leningrad Regional Clinical Oncological Dispensary named after V.I. L.D. Romana"

Kuz'molovskiy, , Russia

"Russian Cancer Research Center named after N.N. Blokhin "of the Ministry of Health of the Russian Federation

Moscow, , Russia

Branch of Hadassah Medical LTD Limited Liability Company

Moscow, , Russia

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)

Moscow, , Russia

Joint Stock Company "K31 City"

Moscow, , Russia

JSC "Medsi Group"

Moscow, , Russia

Moscow City Oncology Hospital No. 62

Moscow, , Russia

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"

Moscow, , Russia

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"

Moscow, , Russia

Nizhny Novgorod Region State Budgetary Healthcare Facility "Clinical Diagnostics Center"

Nizhny Novgorod, , Russia

LLC "DobroMed"

Novosibirsk, , Russia

State Budgetary Healthcare Institution "Novosibirsk Regional Clinical Oncology Center" of the Novosibirsk Region

Novosibirsk, , Russia

Federal State Budgetary Institution "National Medical Research Center for Radiology" of the Ministry of Health of the Russian Federation

Obninsk, , Russia

Budgetary Healthcare Institution of Omsk Region "Clinical Oncology Center"

Omsk, , Russia

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

Pesochnyy, , Russia

LLC "Clinical Trials"

Saint Petersburg, , Russia

JSC "Modern Medical Technologies"

Saint Petersburg, , Russia

City Hospital #40, Kurortny district

Saint Petersburg, , Russia

Federal State Budgetary Educational Institution of Higher Education "Saint Petersburg State University"

Saint Petersburg, , Russia

Federal State Budgetary Health Institution St. Petersburg Clinical Hospital of the Russian Academy of Sciences

Saint Petersburg, , Russia

Limited Liability Company "EuroCityClinic"

Saint Petersburg, , Russia

Limited Liability Company "Oncological Research Center"

Saint Petersburg, , Russia

Limited Liability Company "Stepmed Clinic"

Saint Petersburg, , Russia

Limited Liability Company "Strategic Medical Systems"

Saint Petersburg, , Russia

LLC "AV medical group"

Saint Petersburg, , Russia

N.N. Petrov National Medicine Research Center of oncology

Saint Petersburg, , Russia

Private Medical Institution Evromedservis

Saint Petersburg, , Russia

State budgetary health care institution "St. Petersburg Clinical Scientific and Practical Center of Specialized Medical Assistance (Oncological)"

Saint Petersburg, , Russia

Private institution educational organization of higher education "Medical University "Reaviz"

Samara, , Russia

Federal State Educational Institution of Higher Professional Education "Mordovia State University N.P. Ogareva "

Saransk, , Russia

Oncology Dispensary 2

Sochi, , Russia

State Health Care Institution "Volgograd Regional Clinical Oncology Dispensary № 1"

Volgograd, , Russia

State Regional Budgetary Healthcare Institution "Regional Clinical Oncology Hospital" of the Yaroslavl Region

Yaroslavl, , Russia

Countries

Belarus; India; Russia

Other Identifiers

BCD-217-2

Identifier Type: -

Identifier Source: org_study_id