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
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
1 other identifier
interventional
270
3 countries
63
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Aug 2022
Typical duration for phase_3
63 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 2, 2022
CompletedFirst Submitted
Initial submission to the registry
February 8, 2023
CompletedFirst Posted
Study publicly available on registry
February 17, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 20, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2025
CompletedFebruary 27, 2025
February 1, 2025
1.9 years
February 8, 2023
February 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free survival
24 months
Secondary Outcomes (13)
Overall survival
24 months
Overall response rate (partial response + complete response rate)
24 months
Disease control rate (stable disease + partial response + complete response rate)
24 months
Time to response
24 months
Duration of response
24 months
- +8 more secondary outcomes
Study Arms (2)
BCD-217 (nurulimab + prolgolimab)
EXPERIMENTALBCD-217 followed by prolgolimab 1 mg/kg monotherapy.
BCD-100 (prolgolimab)
ACTIVE COMPARATORProlgolimab monotherapy.
Interventions
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).
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).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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) ;
- +25 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biocadlead
Study Sites (63)
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, 220013, 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
SÅ«rat, India
Chelyabinsk Regional Clinical Center for Oncology and Nuclear Medicine
Chelyabinsk, Chelyabinsk Oblast, 454087, Russia
LLC "New Clinic"
Pyatigorsk, Stavropol Kray, 357500, 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, 156005, 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, 603006, 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, 188663, Russia
JSC "Modern Medical Technologies"
Saint Petersburg, 190013, 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, 354057, Russia
State Health Care Institution "Volgograd Regional Clinical Oncology Dispensary â„– 1"
Volgograd, Russia
State Regional Budgetary Healthcare Institution "Regional Clinical Oncology Hospital" of the Yaroslavl Region
Yaroslavl, 150054, Russia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 8, 2023
First Posted
February 17, 2023
Study Start
August 2, 2022
Primary Completion
June 20, 2024
Study Completion
July 1, 2025
Last Updated
February 27, 2025
Record last verified: 2025-02