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MelanomaPhase 3OCTAVANCT05732805

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

A Phase 3 study testing BCD-217 and BCD-100 in people with Melanoma and Melanoma (Skin), run by Biocad at 63 sites in 3 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Melanoma, Melanoma (Skin), Melanoma Stage III
What is being tested?
BCD-217 and BCD-100
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
270 participants
Where
63 sitesin 3 countries
Study dates
2 Aug 2022to Jul 2025
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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;
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  • 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) ;
  • 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;
  • 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.) ;
  • History of interstitial pulmonary disease or pneumonitis requiring systemic glucocorticoids;
  • 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;
  • Hematologic abnormalities :
  • neutrophils <1.5×109/L;
  • platelets <100×109/L;
  • hemoglobin <90 g/L;
  • Renal impairment: creatinine ≥2.5×ULN;
  • 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);
  • Any antitumor treatment within less than 4 weeks or surgery within less than 28 days prior to randomization within 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), active syphilis, 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-100 or BCD-217;
  • A history of hypersensitivity to monoclonal antibody products;
  • Pregnancy or breastfeeding.

Trial locations and contacts

63 sites in 3 countries.

63 sites in 3 countries

Russia43 sites

  • Arkhangelsk Clinical Oncology Dispensary

    Arkhangelsk

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

    Barnaul

  • Chelyabinsk Regional Clinical Center for Oncology and Nuclear Medicine

    Chelyabinsk, Chelyabinsk Oblast, 454087

  • Limited Liability Company "EVIMED"

    Chelyabinsk

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

    Chelyabinsk

  • State budgetary healthcare institution Leningrad Regional Clinical Hospital

    Gatchina

  • 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'

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

    Kemerovo

  • Regional Goverment Budgetary Healthcare State "Kostroma Oncology Center"

    Kostroma, 156005

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

    Kuz'molovskiy

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

    Moscow

  • Branch of Hadassah Medical LTD Limited Liability Company

    Moscow

  • 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

  • JSC "Medsi Group"

    Moscow

  • Moscow City Oncology Hospital No. 62

    Moscow

  • 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

  • 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 Region State Budgetary Healthcare Facility "Clinical Diagnostics Center"

    Nizhny Novgorod, 603006

  • LLC "DobroMed"

    Novosibirsk

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

    Novosibirsk

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

    Obninsk

  • Budgetary Healthcare Institution of Omsk Region "Clinical Oncology Center"

    Omsk

  • 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 "New Clinic"

    Pyatigorsk, Stavropol Kray, 357500

  • LLC "Clinical Trials"

    Saint Petersburg, 188663

  • JSC "Modern Medical Technologies"

    Saint Petersburg, 190013

  • City Hospital #40, Kurortny district

    Saint Petersburg

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

    Saint Petersburg

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

    Saint Petersburg

  • Limited Liability Company "EuroCityClinic"

    Saint Petersburg

  • Limited Liability Company "Oncological Research Center"

    Saint Petersburg

  • Limited Liability Company "Stepmed Clinic"

    Saint Petersburg

  • Limited Liability Company "Strategic Medical Systems"

    Saint Petersburg

  • LLC "AV medical group"

    Saint Petersburg

  • N.N. Petrov National Medicine Research Center of oncology

    Saint Petersburg

  • Private Medical Institution Evromedservis

    Saint Petersburg

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

    Saint Petersburg

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

    Samara

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

    Saransk

  • Oncology Dispensary 2

    Sochi, 354057

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

    Volgograd

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

    Yaroslavl, 150054

Other trials in Russia

India12 sites

  • Fortis Hospital

    Faridabad

  • Kasturba Medical College and Hospital

    Mangalore

  • TATA Memorial Hospital

    Mumbai

  • HealthCare Global Enterprises Ltd, NCHRI Cancer Center

    Nagpur

  • HealthCare Global Enterprises Ltd Manavata cancer Centre

    Nashik

  • Sankalp Superspeciality Hospital

    Nashik

  • All India Institute of Medical Science

    New Delhi

  • Deenanath Mangeshkar Hospital & Research Center

    Pune

  • PDEAS Ayurved Rugnalaya & Steriling Multispeciality Hospital

    Pune

  • Horizon Mulitispeciality Hospital

    Sangli

  • Shalby Hospital

    Surat

  • Kiran Multispeciality hospital &Research

    Sūrat

Other trials in India

Belarus8 sites

  • Healthcare Institution "Bobruisk Interdistrict Oncological Dispensary"

    Babruysk

  • Healthcare Institution "Brest Regional Oncological Dispensary"

    Brest

  • Health care institution "Grodno University Clinic"

    Grodno

  • Health Institution "Gomel Regional Clinical Oncology Center"

    Homyel

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

    Lesnoy

  • Healthcare Institution "Minsk City Clinical Cancer Center"

    Minsk, 220013

  • State Institution "Mogilev Regional Oncological Dispensary"

    Mogilev

  • Healthcare Institution "Vitebsk Regional Clinical Oncology Center"

    Vitebsk

Other trials in Belarus

About this study

Official title: 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

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.

Read the 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)
Being tested
BCD-217, BCD-100, Placebo
Keywords
PD-1, CTLA-4, prolgolimab, nurulimab, immunotherapy, checkpoint inhibitors, CPI, programm death, cytotoxic T-lymphocyte-associated protein
Medical subject headings
Melanoma, Diabetes Mellitus, Insulin-Dependent, 12

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BCD-217Biological

    Also called nurulimab+prolgolimab

    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-100Biological

    Also called prolgolimab, Forteca

    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).

  • PlaceboBiological

    Placebo

Study groups in NCT05732805
Study groupRoleWhat they receive
BCD-217 (nurulimab + prolgolimab)ExperimentalBCD-217 followed by prolgolimab 1 mg/kg monotherapy.
Receives: Biological: BCD-217; Biological: BCD-100; Biological: Placebo
BCD-100 (prolgolimab)Active comparatorProlgolimab monotherapy.
Receives: Biological: BCD-100; Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival

    Measured: 24 months

Secondary outcomes (13)

  1. Overall survival

    Measured: 24 months

  2. Overall response rate (partial response + complete response rate)

    Measured: 24 months

  3. Disease control rate (stable disease + partial response + complete response rate)

    Measured: 24 months

  4. Time to response

    Measured: 24 months

  5. Duration of response

    Measured: 24 months

  6. The proportion of subjects experiencing adverse events related to study therapy

    Measured: 24 months

  7. The proportion of subjects experiencing any grade 3 or higher adverse events

    Measured: 24 months

  8. The proportion of subjects with SAEs

    Measured: 24 months

  9. The proportion of subjects with immune-related adverse events of any severity

    Measured: 24 months

  10. The proportion of subjects with severe immune-related adverse events

    Measured: 24 months

  11. The proportion of subjects requiring treatment discontinuation due to AEs

    Measured: 24 months

  12. The proportion of BAb and NAb positive subjects

    Measured: 24 months

  13. Ctrough (plasma concentration of anti-PD-1/CTLA-4 monoclonal antibody measured at the end of the dosing interval before the next dose)

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2023
  2. Study start2 Aug 2022
  3. Primary completion20 Jun 2024
  4. Study completionJul 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
270 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05732805
Sponsor's protocol ID
BCD-217-2
Acronym
OCTAVA
Status last verified
Feb 2025
First submitted
8 Feb 2023
Last updated
27 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BCD-217 and BCD-100 in people with Melanoma and Melanoma (Skin), run by Biocad at 63 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 40 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 63 sites in Russia, India, Belarus. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05732805.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2025.

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