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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05732805
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Biocad
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Active, not recruiting
Countries Belarus, India, Russian Federation
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Melanoma, Melanoma (Skin), Melanoma Stage III, Melanoma Stage IV, Melanoma Unresectable, Melanoma Metastatic, Melanoma Advanced
Additional Details

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)

Arms & Interventions

Arms

Experimental: BCD-217 (nurulimab + prolgolimab)

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

Active Comparator: BCD-100 (prolgolimab)

Prolgolimab monotherapy.

Interventions

Biological: - 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).

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).

Biological: - Placebo

Placebo

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Babruysk, Belarus

Status

Address

Healthcare Institution "Bobruisk Interdistrict Oncological Dispensary"

Babruysk, ,

Brest, Belarus

Status

Address

Healthcare Institution "Brest Regional Oncological Dispensary"

Brest, ,

Gomel, Belarus

Status

Address

Health Institution "Gomel Regional Clinical Oncology Center"

Gomel, ,

Grodno, Belarus

Status

Address

Health care institution "Grodno University Clinic"

Grodno, ,

Lesnoy, Belarus

Status

Address

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

Lesnoy, ,

Minsk, Belarus

Status

Address

Healthcare Institution "Minsk City Clinical Cancer Center"

Minsk, , 220013

Mogilev, Belarus

Status

Address

State Institution "Mogilev Regional Oncological Dispensary"

Mogilev, ,

Vitebsk, Belarus

Status

Address

Healthcare Institution "Vitebsk Regional Clinical Oncology Center"

Vitebsk, ,

Fortis Hospital, Faridabad, India

Status

Address

Fortis Hospital

Faridabad, ,

Kasturba Medical College and Hospital, Mangalore, India

Status

Address

Kasturba Medical College and Hospital

Mangalore, ,

TATA Memorial Hospital, Mumbai, India

Status

Address

TATA Memorial Hospital

Mumbai, ,

Nagpur, India

Status

Address

HealthCare Global Enterprises Ltd, NCHRI Cancer Center

Nagpur, ,

Nashik, India

Status

Address

HealthCare Global Enterprises Ltd Manavata cancer Centre

Nashik, ,

Sankalp Superspeciality Hospital, Nashik, India

Status

Address

Sankalp Superspeciality Hospital

Nashik, ,

All India Institute of Medical Science, New Delhi, India

Status

Address

All India Institute of Medical Science

New Delhi, ,

Pune, India

Status

Address

Deenanath Mangeshkar Hospital & Research Center

Pune, ,

Pune, India

Status

Address

PDEAS Ayurved Rugnalaya & Steriling Multispeciality Hospital

Pune, ,

Horizon Mulitispeciality Hospital, Sangli, India

Status

Address

Horizon Mulitispeciality Hospital

Sangli, ,

Shalby Hospital, Surat, India

Status

Address

Shalby Hospital

Surat, ,

Kiran Multispeciality hospital &Research, Sūrat, India

Status

Address

Kiran Multispeciality hospital &Research

Sūrat, ,

Chelyabinsk, Chelyabinsk Oblast, Russian Federation

Status

Address

Chelyabinsk Regional Clinical Center for Oncology and Nuclear Medicine

Chelyabinsk, Chelyabinsk Oblast, 454087

LLC "New Clinic", Pyatigorsk, Stavropol Krai, Russian Federation

Status

Address

LLC "New Clinic"

Pyatigorsk, Stavropol Krai, 357500

Arkhangelsk Clinical Oncology Dispensary, Arkhangel'sk, Russian Federation

Status

Address

Arkhangelsk Clinical Oncology Dispensary

Arkhangel'sk, ,

Barnaul, Russian Federation

Status

Address

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

Barnaul, ,

Limited Liability Company "EVIMED", Chelyabinsk, Russian Federation

Status

Address

Limited Liability Company "EVIMED"

Chelyabinsk, ,

Chelyabinsk, Russian Federation

Status

Address

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

Chelyabinsk, ,

Gatchina, Russian Federation

Status

Address

State budgetary healthcare institution Leningrad Regional Clinical Hospital

Gatchina, ,

Kazan, Russian Federation

Status

Address

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, ,

Kemerovo, Russian Federation

Status

Address

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

Kemerovo, ,

Kostroma, Russian Federation

Status

Address

Regional Goverment Budgetary Healthcare State "Kostroma Oncology Center"

Kostroma, , 156005

Kuz'molovskiy, Russian Federation

Status

Address

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

Kuz'molovskiy, ,

Moscow, Russian Federation

Status

Address

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

Moscow, ,

Moscow, Russian Federation

Status

Address

Branch of Hadassah Medical LTD Limited Liability Company

Moscow, ,

Moscow, Russian Federation

Status

Address

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, ,

Joint Stock Company "K31 City", Moscow, Russian Federation

Status

Address

Joint Stock Company "K31 City"

Moscow, ,

JSC "Medsi Group", Moscow, Russian Federation

Status

Address

JSC "Medsi Group"

Moscow, ,

Moscow City Oncology Hospital No. 62, Moscow, Russian Federation

Status

Address

Moscow City Oncology Hospital No. 62

Moscow, ,

Moscow, Russian Federation

Status

Address

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, ,

Moscow, Russian Federation

Status

Address

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, ,

Nizhny Novgorod, Russian Federation

Status

Address

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

Nizhny Novgorod, , 603006

LLC "DobroMed", Novosibirsk, Russian Federation

Status

Address

LLC "DobroMed"

Novosibirsk, ,

Novosibirsk, Russian Federation

Status

Address

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

Novosibirsk, ,

Obninsk, Russian Federation

Status

Address

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

Obninsk, ,

Omsk, Russian Federation

Status

Address

Budgetary Healthcare Institution of Omsk Region "Clinical Oncology Center"

Omsk, ,

Pesochnyy, Russian Federation

Status

Address

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, ,

LLC "Clinical Trials", Saint Petersburg, Russian Federation

Status

Address

LLC "Clinical Trials"

Saint Petersburg, , 188663

JSC "Modern Medical Technologies", Saint Petersburg, Russian Federation

Status

Address

JSC "Modern Medical Technologies"

Saint Petersburg, , 190013

Saint Petersburg, Russian Federation

Status

Address

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

Saint Petersburg, ,

Saint Petersburg, Russian Federation

Status

Address

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

Saint Petersburg, ,

Saint Petersburg, Russian Federation

Status

Address

Limited Liability Company "EuroCityClinic"

Saint Petersburg, ,

Saint Petersburg, Russian Federation

Status

Address

Limited Liability Company "Oncological Research Center"

Saint Petersburg, ,

Saint Petersburg, Russian Federation

Status

Address

Limited Liability Company "Stepmed Clinic"

Saint Petersburg, ,

Saint Petersburg, Russian Federation

Status

Address

Limited Liability Company "Strategic Medical Systems"

Saint Petersburg, ,

LLC "AV medical group", Saint Petersburg, Russian Federation

Status

Address

LLC "AV medical group"

Saint Petersburg, ,

Saint Petersburg, Russian Federation

Status

Address

N.N. Petrov National Medicine Research Center of oncology

Saint Petersburg, ,

Saint Petersburg, Russian Federation

Status

Address

Private Medical Institution Evromedservis

Saint Petersburg, ,

Samara, Russian Federation

Status

Address

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

Samara, ,

Sankt Petersburg, Russian Federation

Status

Address

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

Sankt Petersburg, ,

Saransk, Russian Federation

Status

Address

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

Saransk, ,

Oncology Dispensary 2, Sochi, Russian Federation

Status

Address

Oncology Dispensary 2

Sochi, , 354057

City Hospital #40, Kurortny district, St. Petersburg, Russian Federation

Status

Address

City Hospital #40, Kurortny district

St. Petersburg, ,

Volgograd, Russian Federation

Status

Address

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

Volgograd, ,

Yaroslavl, Russian Federation

Status

Address

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

Yaroslavl, , 150054

Stay Informed & Connected