Clincosm LogoSign in Get a demo

OCTAVA: 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

Sponsor
Biocad (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05732805
Collaborator
(none)
270
Enrollment
63
Locations
2
Arms
32
Anticipated Duration (Months)
4.3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: BCD-217
  • Biological: BCD-100
  • Biological: Placebo
 Phase 3

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)

Study Design

Study Type:
Interventional
Anticipated Enrollment :
270 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Aug 2, 2022
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Apr 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: BCD-217 (nurulimab + prolgolimab)

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

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).
Other Names:
  • nurulimab+prolgolimab

    • 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).
    Other Names:
  • prolgolimab
  • Forteca

    • Biological: Placebo
    Placebo
    Active Comparator: BCD-100 (prolgolimab)

    Prolgolimab monotherapy.

    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).
    Other Names:
  • prolgolimab
  • Forteca

    • Biological: Placebo
    Placebo

    Outcome Measures

    Primary Outcome Measures

    1. Progression-free survival [24 months]

    Secondary Outcome Measures

    1. Overall survival [24 months]

    2. Overall response rate (partial response + complete response rate) [24 months]

    3. Disease control rate (stable disease + partial response + complete response rate) [24 months]

    4. Time to response [24 months]

    5. Duration of response [24 months]

    6. The proportion of subjects experiencing adverse events related to study therapy [24 months]

    7. The proportion of subjects experiencing any grade 3 or higher adverse events [24 months]

    8. The proportion of subjects with SAEs [24 months]

    9. The proportion of subjects with immune-related adverse events of any severity [24 months]

    10. The proportion of subjects with severe immune-related adverse events [24 months]

    11. The proportion of subjects requiring treatment discontinuation due to AEs [24 months]

    12. The proportion of BAb and NAb positive subjects [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) [24 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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;

    1. 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.) ;

    2. History of interstitial pulmonary disease or pneumonitis requiring systemic glucocorticoids;

    3. 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;

    4. Hematologic abnormalities :

    • neutrophils <1.5×109/L;

    • platelets <100×109/L;

    • hemoglobin <90 g/L;

    1. Renal impairment: creatinine ≥2.5×ULN;

    2. 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);

    1. Any antitumor treatment within less than 4 weeks or surgery within less than 28 days prior to randomization within the study;

    2. History of oncological disease, except for radically treated diseases with remission for over 5 years prior randomization in this study ;

    3. Conditions limiting the subject's ability to comply with the Protocol requirements (in the Investigator's opinion );

    4. Participation in other clinical studies within less than 30 days prior to randomization and during this clinical study ;

    5. Acute infections or activation of chronic infectious diseases or systemic antibacterial therapy within less than 28 days prior to randomization;

    6. Active hepatitis B, active hepatitis C (confirmed by PCR), active syphilis, HIV-infection, currently or previously ;

    7. Impossibility to administer the investigational product intravenously;

    8. Impossibility to administer intravenous contrast agents (including due to hypersensitivity to contrast media);

    9. Hypersensitivity to any of the components of BCD-100 or BCD-217;

    10. A history of hypersensitivity to monoclonal antibody products;

    11. Pregnancy or breastfeeding.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Healthcare Institution "Bobruisk Interdistrict Oncological Dispensary" Babruysk Belarus
    2 Healthcare Institution "Brest Regional Oncological Dispensary" Brest Belarus
    3 Health Institution "Gomel Regional Clinical Oncology Center" Gomel Belarus
    4 Health care institution "Grodno University Clinic" Grodno Belarus
    5 State Institution "Republican Scientific and Practical Center of Oncology and Medical Radiology named after A.I. N.N. Alexandrov" Lesnoy Belarus
    6 Healthcare Institution "Minsk City Clinical Cancer Center" Minsk Belarus 220013
    7 State Institution "Mogilev Regional Oncological Dispensary" Mogilev Belarus
    8 Healthcare Institution "Vitebsk Regional Clinical Oncology Center" Vitebsk Belarus
    9 Fortis Hospital Faridabad India
    10 Kasturba Medical College and Hospital Mangalore India
    11 TATA Memorial Hospital Mumbai India
    12 HealthCare Global Enterprises Ltd, NCHRI Cancer Center Nagpur India
    13 HealthCare Global Enterprises Ltd Manavata cancer Centre Nashik India
    14 Sankalp Superspeciality Hospital Nashik India
    15 All India Institute of Medical Science New Delhi India
    16 Deenanath Mangeshkar Hospital & Research Center Pune India
    17 PDEAS Ayurved Rugnalaya & Steriling Multispeciality Hospital Pune India
    18 Horizon Mulitispeciality Hospital Sangli India
    19 Shalby Hospital Surat India
    20 Kiran Multispeciality hospital &Research Sūrat India
    21 Chelyabinsk Regional Clinical Center for Oncology and Nuclear Medicine Chelyabinsk Chelyabinsk Oblast Russian Federation 454087
    22 LLC "New Clinic" Pyatigorsk Stavropol Krai Russian Federation 357500
    23 Arkhangelsk Clinical Oncology Dispensary Arkhangel'sk Russian Federation
    24 Regional State Budgetary Institution of Health Care "Altai Regional Oncological Dispensary" Barnaul Russian Federation
    25 Limited Liability Company "EVIMED" Chelyabinsk Russian Federation
    26 Private healthcare institution "Clinical hospital "RZD-Medicine" of the city of Chelyabinsk" Chelyabinsk Russian Federation
    27 State budgetary healthcare institution Leningrad Regional Clinical Hospital Gatchina Russian Federation
    28 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 Russian Federation
    29 State budgetary health care institution "Kuzbass clinical oncological dispensary named after M.S. Rappoport" Kemerovo Russian Federation
    30 Regional Goverment Budgetary Healthcare State "Kostroma Oncology Center" Kostroma Russian Federation 156005
    31 State Budgetary Institution of Healthcare "Leningrad Regional Clinical Oncological Dispensary named after V.I. L.D. Romana" Kuz'molovskiy Russian Federation
    32 "Russian Cancer Research Center named after N.N. Blokhin "of the Ministry of Health of the Russian Federation Moscow Russian Federation
    33 Branch of Hadassah Medical LTD Limited Liability Company Moscow Russian Federation
    34 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 Russian Federation
    35 Joint Stock Company "K31 City" Moscow Russian Federation
    36 JSC "Medsi Group" Moscow Russian Federation
    37 Moscow City Oncology Hospital No. 62 Moscow Russian Federation
    38 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 Russian Federation
    39 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 Russian Federation
    40 Nizhny Novgorod Region State Budgetary Healthcare Facility "Clinical Diagnostics Center" Nizhny Novgorod Russian Federation 603006
    41 LLC "DobroMed" Novosibirsk Russian Federation
    42 State Budgetary Healthcare Institution "Novosibirsk Regional Clinical Oncology Center" of the Novosibirsk Region Novosibirsk Russian Federation
    43 Federal State Budgetary Institution "National Medical Research Center for Radiology" of the Ministry of Health of the Russian Federation Obninsk Russian Federation
    44 Budgetary Healthcare Institution of Omsk Region "Clinical Oncology Center" Omsk Russian Federation
    45 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 Russian Federation
    46 LLC "Clinical Trials" Saint Petersburg Russian Federation 188663
    47 JSC "Modern Medical Technologies" Saint Petersburg Russian Federation 190013
    48 Federal State Budgetary Educational Institution of Higher Education "Saint Petersburg State University" Saint Petersburg Russian Federation
    49 Federal State Budgetary Health Institution St. Petersburg Clinical Hospital of the Russian Academy of Sciences Saint Petersburg Russian Federation
    50 Limited Liability Company "EuroCityClinic" Saint Petersburg Russian Federation
    51 Limited Liability Company "Oncological Research Center" Saint Petersburg Russian Federation
    52 Limited Liability Company "Stepmed Clinic" Saint Petersburg Russian Federation
    53 Limited Liability Company "Strategic Medical Systems" Saint Petersburg Russian Federation
    54 LLC "AV medical group" Saint Petersburg Russian Federation
    55 N.N. Petrov National Medicine Research Center of oncology Saint Petersburg Russian Federation
    56 Private Medical Institution Evromedservis Saint Petersburg Russian Federation
    57 Private institution educational organization of higher education "Medical University "Reaviz" Samara Russian Federation
    58 State budgetary health care institution "St. Petersburg Clinical Scientific and Practical Center of Specialized Medical Assistance (Oncological)" Sankt Petersburg Russian Federation
    59 Federal State Educational Institution of Higher Professional Education "Mordovia State University N.P. Ogareva " Saransk Russian Federation
    60 Oncology Dispensary 2 Sochi Russian Federation 354057
    61 City Hospital #40, Kurortny district St. Petersburg Russian Federation
    62 State Health Care Institution "Volgograd Regional Clinical Oncology Dispensary № 1" Volgograd Russian Federation
    63 State Regional Budgetary Healthcare Institution "Regional Clinical Oncology Hospital" of the Yaroslavl Region Yaroslavl Russian Federation 150054

    Sponsors and Collaborators

    • Biocad

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Biocad
    ClinicalTrials.gov Identifier:
    NCT05732805
    Other Study ID Numbers:
    • BCD-217-2
    First Posted:
    Feb 17, 2023
    Last Update Posted:
    Feb 17, 2023
    Last Verified:
    Feb 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Biocad
    PD-1
    CTLA-4
    prolgolimab
    nurulimab
    immunotherapy
    checkpoint inhibitors
    CPI
    programm death
    cytotoxic T-lymphocyte-associated protein
    Additional relevant MeSH terms:
    Melanoma

    Study Results

    No Results Posted as of Feb 17, 2023