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Study of Efficacy and Safety of BCD-217 (Anti-CTLA-4 and Anti-PD-1) Followed By BCD-100 (Anti-PD-1) Versus BCD-100 Monotherapy as First-Line Treatment in Patients With Unresectable or Metastatic Melanoma

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ClinicalTrials.gov Identifier: NCT03913923
Recruitment Status : Not yet recruiting
First Posted : April 12, 2019
Last Update Posted : May 9, 2019
Sponsor:
Information provided by (Responsible Party):
Biocad

Brief Summary:
This is a multicenter randomized double-blind placebo-controlled phase II clinical trial. The purpose of this trial is to evaluate efficacy and safety of therapy consisting of BCD-217 (fixed dose combination of anti-CTLA-4 and anti-PD-1 monoclonal antibodies) and sequential BCD-100 (anti-PD-1 monoclonal antibody) versus BCD-100 monotherapy as first-line treatment in patients with treatment-naïve unresectable or metastatic melanoma.

Condition or disease Intervention/treatment Phase
Melanoma Melanoma Metastatic Biological: BCD-217 Biological: BCD-100 Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: International Multicenter Double-Blind Placebo-Controlled Comparative Randomized Trial of Efficacy and Safety of BCD-217 (Anti-CTLA-4 and Anti-PD-1) And BCD-100 (Anti-PD-1) Therapy Compared to BCD-100 Monotherapy as First-Line Treatment in Patients With Unresectable or Metastatic Melanoma
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Arm Intervention/treatment
Experimental: BCD-217 and BCD-100
Patients will receive 4 blinded infusions of BCD-217 plus Placebo. Starting with the fith infusion patients will receive unblinded BCD-100 monotherapy.
Biological: BCD-217
Combination of anti-CTLA-4 and anti-PD-1 monoclonal antibodies, 1mg/kg and 3 mg/mg, respectively, given Q3W as IV infusion

Biological: BCD-100
Anti-PD-1 monoclonal antibody, 1 mg/kg, given Q2W as IV infusion

Other: Placebo
Placebo

Active Comparator: BCD-100 monotherapy
Patients will receive 4 blinded infusions of BCD-100 plus Placebo. Starting with the fith infusion patients will receive unblinded BCD-100 monotherapy.
Biological: BCD-100
Anti-PD-1 monoclonal antibody, 1 mg/kg, given Q2W as IV infusion

Other: Placebo
Placebo




Primary Outcome Measures :
  1. Median Progression-Free Survival [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Progression-Free Survival (PFS) [ Time Frame: 2 years ]
    The time from the date of randomization until progression of disease per RECIST 1.1 and iRECIST or death

  2. Overall Survival (OS) [ Time Frame: 3 years ]
    The time from the date of randomization until death

  3. Overall Response Rate [ Time Frame: 2 years ]
    The percentage of the participants who have a Complete Response or a Partial Response as assessed by a blind independent central reviewer per RECIST 1.1. and iRECIST

  4. Disease Control Rate [ Time Frame: 2 years ]
    The percentage of the participants who have a Complete Response, a Partial Response or a Stable DIsease as assessed by a blind independent central reviewer per RECIST 1.1. and iRECIST

  5. Time to Response (TTR) [ Time Frame: 2 years ]
    TTR will be calculated from the randomization date

  6. Duration of Response [ Time Frame: 2 years ]
    DOR will be calculated from the moment of registration of response till event (progression or death)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed Informed Consent Form and the subject's ability to follow the Protocol requirements;
  2. Age: 18 years and older at the signing of the informed consent;
  3. Histologically verified (documented) melanoma;
  4. Previously untreated unresectable stage III melanoma or metastatic stage IV melanoma;
  5. Available tissue blocks for histological examination or patient's agreement to give biopsy specimens
  6. Patient's consent for PD-L1 expression status and BRAF V600 testing;
  7. ECOG performance status of 0 or 1;
  8. Life expectancy of at least 12 weeks from the screening;
  9. At least one RECIST 1.1-defined measurable target lesion confirmed by an independent review;
  10. Patients with reproductive potential must agree to practice acceptable methods of birth control throughout the entire trial period, starting from signing the informed consent and up to 24 weeks after the last dose of investigational drug.

Exclusion Criteria:

  1. Indications for radical therapy (surgical or radiotherapy);
  2. Prior anti-cancer therapy for unresectable/metastatic melanoma;
  3. Previous use of checkpoint inhibitors, including PD-1/PD-L1/PD-L2/CTLA-4 agents;
  4. Use of immunostimulants, monoclonal antibodies and/or colony-stimulating factors within less than 4 weeks prior to randomization to this study;
  5. Ocular melanoma;
  6. Central nervous system (CNS) metastases;
  7. Evidence of severe or concomitant diseases/life-threatening complications of the main condition (e.g., massive pleural, pericardial, or peritoneal effusion that requires medical intervention , pulmonary lymphangitis) at the signing of the informed consent;
  8. Any concomitant disease observed at the screening that increases the risk of adverse events during the investigational therapy:

    1. Grade III—IV stable angina;
    2. Unstable angina or a history of myocardial infarction within 6 months prior to signing the informed consent;
    3. Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system;
    4. Severe, resistant hypertension;
    5. History of atopic asthma, angioedema;
    6. Moderate to severe respiratory failure, Grade 3 to 4 chronic obstructive pulmonary disease;
    7. Any other concomitant condition (e.g., metabolism, blood, hepatic, renal, pulmonary, neurological, endocrine, cardiac, infectious, or gastrointestinal disorder) that constitutes an unacceptable risk to the patient's health during the investigational therapy;
  9. Systemic autoimmune diseases (including but not limited to SLE, Crohn's disease, ulcerative colitis, systemic scleroderma, inflammatory myopathy, mixed connective tissue disease, overlap syndrome, etc.);
  10. Interstitial lung disease or pneumonia, requiring systemic use of corticosteroids;
  11. Patients who need therapy with corticosteroids or other immunosuppressants within 2 weeks prior to randomization;
  12. Hematologic disorders: neutrophils <1500/mcl or platelets <100 000/mcl or hemoglobin <90 g/l;
  13. Renal disorders: creatinine ≥ 1.5 x UNL;
  14. Hepatic disorders: bilirubin ≥ 1.5 x UNL (excluding Gilbert's syndrome if bilirubin < 50 µmol/l) or AST/ALT ≥ 3 x UNL (excluding subjects with liver metastases if AST/ALT < 5 x UNL) or alkaline phosphatase ≥ 5 x UNL;
  15. Any anti-cancer therapy less than 28 days prior to randomization;
  16. History of cancer (except for radically treated with at least 5 years in remission);
  17. Any condition that prevents a patient from following the Protocol procedures (dementia, neurological or mental disorders, drug/alcohol abuse, etc.);
  18. Simultaneous participation in other clinical trials , participation in other clinical trials within 30 days prior to randomization;
  19. Acute infection or the acute phase of chronic infection within 28 days prior to randomization;
  20. Active HBV/HCV/HIV infection, active syphilis;
  21. Patients unable to receive an IV infusion of BCD-100;
  22. Patients unable to receive an IV contrast agent;
  23. Hypersensitivity to any of the components of BCD-100 and BCD-217;
  24. History of hypersensitivity to any therapeutic monoclonal antibody;
  25. Pregnant or lactating female.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03913923


Contacts
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Contact: Mariia S Shustova, MD +7-(812)-380-49-33 biocad@biocad.ru
Contact: Fedor B Kryukov, MD, PhD +7-(812)-380-49-33 biocad@biocad.ru

Sponsors and Collaborators
Biocad
Investigators
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Study Director: Roman A Ivanov, PhD Vice President R&D, JSC BIOCAD

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Responsible Party: Biocad
ClinicalTrials.gov Identifier: NCT03913923     History of Changes
Other Study ID Numbers: BCD-217-1/OBERTON
First Posted: April 12, 2019    Key Record Dates
Last Update Posted: May 9, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas