xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05986331</url>
    </required_header>
    <id_info>
      <org_study_id>BCD-201-2</org_study_id>
      <nct_id>NCT05986331</nct_id>
    </id_info>
    <brief_title>Clinical Study of the Efficacy and Safety of BCD-201 and Keytruda in Subjects With Advanced Melanoma</brief_title>
    <official_title>A Randomized, Double-Blind Clinical Study of the Efficacy and Safety of BCD-201 (JSC BIOCAD) and Keytruda® in Patients With Unresectable or Metastatic Melanoma</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Biocad</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Biocad</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This clinical study is designed as a randomized, double-blind trial. Subjects with&#xD;
        unresectable, metastatic, or recurrent skin melanoma will be randomized to one of the two&#xD;
        study groups (BCD-201 group and Keytruda group) at a 1:1 ratio.&#xD;
  &#xD;
        The goal of this study is to compare the efficacy and safety of BCD-201 and Keytruda as&#xD;
        first-line therapy in subjects with unresectable, metastatic, or recurrent skin melanoma.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 18, 2022</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">July 31, 2023</primary_completion_date>
    <phase>Phase 3</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>To compare the overall response rate (ORR) in the BCD-201 group and the Keytruda group</measure>
      <time_frame>24 weeks of treatment</time_frame>
      <description>ORR according to RECIST 1.1</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>To compare the ORR according to iRECIST in the BCD-201 group and the Keytruda group</measure>
      <time_frame>every 12 weeks up to 2 years</time_frame>
      <description>ORR according to iRECIST</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To compare the duration of response in the BCD-201 group and the Keytruda group</measure>
      <time_frame>up to 2 years</time_frame>
      <description>Duration of response will be calculated from the moment of registration of response till event (progression or death)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To compare the time to response according to RECIST 1.1 and iRECIST in the BCD-201 group and the Keytruda group</measure>
      <time_frame>every 12 weeks up to 2 years</time_frame>
      <description>time to response will be calculated from the randomization date</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To compare the disease control rate in the BCD-201 group and the Keytruda group</measure>
      <time_frame>up to 2 years</time_frame>
      <description>The percentage of the participants who have a Complete Response, a Partial Response or a Stable DIsease</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To compare the progression-free survival (PFS) per RECIST 1.1 and iRECIST in the BCD-201 group and the Keytruda group</measure>
      <time_frame>up to 2 years</time_frame>
      <description>The time from the date of randomization until progression of disease according to RECIST 1.1 / iRECIST criteria or death</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To compare the overall survival in the BCD-201 group and the Keytruda group</measure>
      <time_frame>up to 2 years</time_frame>
      <description>The time from the date of randomization until death</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To compare the incidence of Treatment-Emergent Adverse Events (Safety profiles of BCD-201 and Keytruda)</measure>
      <time_frame>through study completion, an average of 2 years.</time_frame>
      <description>Presence of any adverse events (AEs), presence of adverse reactions (ARs), presence of serious adverse reactions (SARs), presence of severe ARs (grade 3 or higher severity according to CTCAE v.5.0), presence of ARs leading to discontinuation of study therapy, presence of immune-mediated AEs</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Area under the concentration-time curve (AUC(0-504))</measure>
      <time_frame>up to 24 weeks of the double-blind treatment period</time_frame>
      <description>Area under the plasma concentration versus time curve in the time interval from 0 to 504 hours</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>AUC(0-∞)</measure>
      <time_frame>up to 24 weeks of the double-blind treatment period</time_frame>
      <description>Area under the plasma concentration versus time curve in the time interval from 0 to time infinity</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Peak Plasma Concentration (Cmax)</measure>
      <time_frame>up to 24 weeks of the double-blind treatment period</time_frame>
      <description>maximum concentration of pembrolizumab</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to maximum concentration (Tmax)</measure>
      <time_frame>up to 24 weeks of the double-blind treatment period</time_frame>
      <description>time to maximum concentration of pembrolizumab</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Elimination rate constant (kel)</measure>
      <time_frame>up to 24 weeks of the double-blind treatment period</time_frame>
      <description>kel of pembrolizumab</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Total clearance (Cl)</measure>
      <time_frame>up to 24 weeks of the double-blind treatment period</time_frame>
      <description>Cl of pembrolizumab</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Steady-state volume of distribution of the drug substance (Vd)</measure>
      <time_frame>up to 24 weeks of the double-blind treatment period</time_frame>
      <description>Vd of pembrolizumab</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Half-life period (T1/2)</measure>
      <time_frame>up to 24 weeks of the double-blind treatment period</time_frame>
      <description>T1/2 of pembrolizumab</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Concentrations at the end of each infusion (CEOI)</measure>
      <time_frame>up to 24 weeks of the double-blind treatment period</time_frame>
      <description>concentrations at the end of each infusion of pembrolizumab</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To compare the immunogenicity of BCD-201 and Keytruda.</measure>
      <time_frame>pre-dose to day169 of the double-blind treatment period, 8 timepoints</time_frame>
      <description>Development of binding and neutralizing antibodies to pembrolizumab</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">366</enrollment>
    <condition>Melanoma (Skin)</condition>
    <arm_group>
      <arm_group_label>BCD-201 group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>BCD-201 200 mg as a 30-minute intravenous infusion once every 3 weeks</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Keytruda</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Keytruda 200 mg as a 30-minute intravenous infusion once every 3 weeks</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>BCD-201</intervention_name>
      <description>up to 8 treatment cycles</description>
      <arm_group_label>BCD-201 group</arm_group_label>
      <other_name>Pembrolizumab</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Keytruda</intervention_name>
      <description>up to 8 treatment cycles</description>
      <arm_group_label>Keytruda</arm_group_label>
      <other_name>pembrolizumab</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Signed informed consent;&#xD;
  &#xD;
            -  Histologically confirmed melanoma;&#xD;
  &#xD;
            -  Tumor first detected at the stage of advanced unresectable or metastatic disease, or&#xD;
               disease progressing during or recurring after previous radical therapy;&#xD;
  &#xD;
            -  ECOG score 0-1;&#xD;
  &#xD;
            -  At least one measurable lesion according to RECIST 1.1;&#xD;
  &#xD;
            -  Laboratory test results consistent with adequate functioning of systems and organs;&#xD;
  &#xD;
            -  Willingness of men and women of childbearing potential to use highly effective&#xD;
               contraceptive methods from the signing of the informed consent form, throughout the&#xD;
               study and for 6 months after the administration of the last product dose.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Indications for radical therapy (surgery, radiation therapy);&#xD;
  &#xD;
            -  Uveal, ocular or mucosal melanoma;&#xD;
  &#xD;
            -  Active CNS metastases and/or carcinomatous meningitis;&#xD;
  &#xD;
            -  Subjects with severe concomitant disorders, life-threatening acute complications of&#xD;
               the primary disease;&#xD;
  &#xD;
            -  Concomitant diseases and/or conditions that significantly increase the risk of AEs&#xD;
               during the study;&#xD;
  &#xD;
            -  Active, known or suspected autoimmune disorders (subjects with type 1 diabetes&#xD;
               mellitus or hypothyroidism requiring only hormone-replacement therapy and those with&#xD;
               skin disorders [vitiligo, alopecia, or psoriasis] not requiring systemic therapy are&#xD;
               eligible to participate);&#xD;
  &#xD;
            -  The need for therapy with glucocorticoids or any other drugs with immunosuppressive&#xD;
               effects within 14 days prior to randomization;&#xD;
  &#xD;
            -  History of (non-infectious) pneumonitis requiring glucocorticoid therapy or&#xD;
               pneumonitis at the time of screening;&#xD;
  &#xD;
            -  Hypersensitivity or allergy to any of the pembrolizumab product components;&#xD;
  &#xD;
            -  Pregnancy or breastfeeding, as well as intention to become pregnant or father a child&#xD;
               during the study period.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Vladimir Chistiakov</last_name>
      <phone>+7 (812) 380 49 34</phone>
      <email>chistiakov@biocad.ru</email>
    </overall_contact>
    <location>
      <facility>
        <name>Budgetary healthcare institution of the Omsk region &quot;Clinical oncological dispensary&quot;</name>
        <address>
          <city>Omsk</city>
          <country>Russian Federation</country>
        </address>
      </facility>
      <status>Active, not recruiting</status>
    </location>
    <location>
      <facility>
        <name>&quot;Saint Petersburg Clinical Research and Practice Center for Specialized Medical Care (Oncology)&quot;</name>
        <address>
          <city>Saint Petersburg</city>
          <country>Russian Federation</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Vladimir Moiseyenko</last_name>
        <email>moiseyenkov@gmail.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Federal State Budgetary Educational Institution of Higher Education &quot;Saint Petersburg State University&quot;</name>
        <address>
          <city>Saint Petersburg</city>
          <country>Russian Federation</country>
        </address>
      </facility>
      <status>Active, not recruiting</status>
    </location>
    <location_countries>
      <country>Russian Federation</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>February 13, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Melanoma</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pembrolizumab</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05986331
  org study id: BCD-201-2
  nct id: NCT05986331
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This clinical study is designed as a randomized, double-blind trial. Subjects with
        unresectable, metastatic, or recurrent skin melanoma will be randomized to one of the two
        study groups (BCD-201 group and Keytruda group) at a 1:1 ratio.
  
        The goal of this study is to compare the efficacy and safety of BCD-201 and Keytruda as
        first-line therapy in subjects with unresectable, metastatic, or recurrent skin melanoma.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: To compare the overall response rate (ORR) in the BCD-201 group and the Keytruda group
  time frame: 24 weeks of treatment
  description: ORR according to RECIST 1.1
  measure: To compare the ORR according to iRECIST in the BCD-201 group and the Keytruda group
  time frame: every 12 weeks up to 2 years
  description: ORR according to iRECIST
  measure: To compare the duration of response in the BCD-201 group and the Keytruda group
  time frame: up to 2 years
  description: Duration of response will be calculated from the moment of registration of response till event (progression or death)
  measure: To compare the time to response according to RECIST 1.1 and iRECIST in the BCD-201 group and the Keytruda group
  time frame: every 12 weeks up to 2 years
  description: time to response will be calculated from the randomization date
  measure: To compare the disease control rate in the BCD-201 group and the Keytruda group
  time frame: up to 2 years
  description: The percentage of the participants who have a Complete Response, a Partial Response or a Stable DIsease
  measure: To compare the progression-free survival (PFS) per RECIST 1.1 and iRECIST in the BCD-201 group and the Keytruda group
  time frame: up to 2 years
  description: The time from the date of randomization until progression of disease according to RECIST 1.1 / iRECIST criteria or death
  measure: To compare the overall survival in the BCD-201 group and the Keytruda group
  time frame: up to 2 years
  description: The time from the date of randomization until death
  measure: To compare the incidence of Treatment-Emergent Adverse Events (Safety profiles of BCD-201 and Keytruda)
  time frame: through study completion, an average of 2 years.
  description: Presence of any adverse events (AEs), presence of adverse reactions (ARs), presence of serious adverse reactions (SARs), presence of severe ARs (grade 3 or higher severity according to CTCAE v.5.0), presence of ARs leading to discontinuation of study therapy, presence of immune-mediated AEs
  measure: Area under the concentration-time curve (AUC(0-504))
  time frame: up to 24 weeks of the double-blind treatment period
  description: Area under the plasma concentration versus time curve in the time interval from 0 to 504 hours
  measure: AUC(0-∞)
  time frame: up to 24 weeks of the double-blind treatment period
  description: Area under the plasma concentration versus time curve in the time interval from 0 to time infinity
  measure: Peak Plasma Concentration (Cmax)
  time frame: up to 24 weeks of the double-blind treatment period
  description: maximum concentration of pembrolizumab
  measure: Time to maximum concentration (Tmax)
  time frame: up to 24 weeks of the double-blind treatment period
  description: time to maximum concentration of pembrolizumab
  measure: Elimination rate constant (kel)
  time frame: up to 24 weeks of the double-blind treatment period
  description: kel of pembrolizumab
  measure: Total clearance (Cl)
  time frame: up to 24 weeks of the double-blind treatment period
  description: Cl of pembrolizumab
  measure: Steady-state volume of distribution of the drug substance (Vd)
  time frame: up to 24 weeks of the double-blind treatment period
  description: Vd of pembrolizumab
  measure: Half-life period (T1/2)
  time frame: up to 24 weeks of the double-blind treatment period
  description: T1/2 of pembrolizumab
  measure: Concentrations at the end of each infusion (CEOI)
  time frame: up to 24 weeks of the double-blind treatment period
  description: concentrations at the end of each infusion of pembrolizumab
  measure: To compare the immunogenicity of BCD-201 and Keytruda.
  time frame: pre-dose to day169 of the double-blind treatment period, 8 timepoints
  description: Development of binding and neutralizing antibodies to pembrolizumab
  arm group label: BCD-201 group
  arm group type: Experimental
  description: BCD-201 200 mg as a 30-minute intravenous infusion once every 3 weeks
  arm group label: Keytruda
  arm group type: Active Comparator
  description: Keytruda 200 mg as a 30-minute intravenous infusion once every 3 weeks
  intervention type: Drug
  intervention name: BCD-201
  description: up to 8 treatment cycles
  arm group label: BCD-201 group
  other name: Pembrolizumab
  intervention type: Drug
  intervention name: Keytruda
  description: up to 8 treatment cycles
  arm group label: Keytruda
  other name: pembrolizumab
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Vladimir Chistiakov
  phone: +7 (812) 380 49 34
  email: chistiakov@biocad.ru
  facility: 
  status: Active, not recruiting
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Active, not recruiting
  country: Russian Federation
  responsible party type: Sponsor
  mesh term: Melanoma
  mesh term: Pembrolizumab
  sharing ipd: No