<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/NCT02247349</url>
  </required_header>
  <id_info>
    <org_study_id>CA001-030</org_study_id>
    <secondary_id>2014-002372-89</secondary_id>
    <nct_id>NCT02247349</nct_id>
  </id_info>
  <brief_title>BMS-986012 in Relapsed/Refractory SCLC</brief_title>
  <official_title>A Phase 1/2 Multicenter Study of BMS-986012 in Subjects With Relapsed/Refractory Small Cell Lung Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bristol-Myers Squibb</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bristol-Myers Squibb</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the safety, tolerability, pharmacokinetics,&#xD;
      immunogenicity, antitumor activity and pharmacodynamics of BMS-986012 alone and in&#xD;
      combination with nivolumab in patients with relapsed/refractory SCLC.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 14, 2014</start_date>
  <completion_date type="Actual">December 21, 2022</completion_date>
  <primary_completion_date type="Actual">December 21, 2022</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety as measured by frequency of worst grade of adverse events (AEs), worst grade of serious adverse events (SAEs), incidence of adverse events leading to discontinuations, and deaths</measure>
    <time_frame>Weekly for 1st and 2nd 21-day cycles, then once every 3 weeks during study treatment, at end of treatment and every 30 days during clinical follow-up until resolution of adverse events or 100 days after the last dose of study medication (Approx 3 years)</time_frame>
    <description>Safety as measured by frequency of worst grade of adverse events (AEs), worst grade of serious adverse events (SAEs), incidence of adverse events leading to discontinuations, and deaths graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), as appropriate</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum observed serum concentration (Cmax) for BMS-986012 (anti-fucosyl-GM1)</measure>
    <time_frame>At multiple timepoints during first 4 cycles then every 4th cycle, at end of treatment and during clinical follow-up (Approx duration of study 3 years)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum observed serum concentration (Cmax) for BMS-986012 (anti-fucosyl-GM1) in combination with Nivolumab</measure>
    <time_frame>At multiple timepoints during first 4 cycles then every 4th cycle, at end of treatment and during clinical follow-up (Approx duration of study 3 years)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time of maximum observed serum concentration (Tmax) for BMS-986012 (anti-fucosyl-GM1)</measure>
    <time_frame>At multiple timepoints during first 4 cycles then every 4th cycle, at end of treatment and during clinical follow-up (Approx duration of study 3 years)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time of maximum observed serum concentration (Tmax) for BMS-986012 (anti-fucosyl-GM1) in combination with Nivolumab</measure>
    <time_frame>At multiple timepoints during first 4 cycles then every 4th cycle, at end of treatment and during clinical follow-up (Approx duration of study 3 years)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Observed serum concentration at the end of a dosing interval (Ctau) for BMS-986012 (anti-fucosyl-GM1)</measure>
    <time_frame>At multiple timepoints during first 4 cycles then every 4th cycle, at end of treatment and during clinical follow-up (Approx duration of study 3 years)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Observed serum concentration at the end of a dosing interval (Ctau) for BMS-986012 (anti-fucosyl-GM1) in combination with Nivolumab</measure>
    <time_frame>At multiple timepoints during first 4 cycles then every 4th cycle, at end of treatment and during clinical follow-up (Approx duration of study 3 years)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the serum concentration-time curve from time zero to time t (AUC(0-t)) for BMS-986012 (anti-fucosyl-GM1) in combination with Nivolumab</measure>
    <time_frame>At multiple timepoints during first 4 cycles then every 4th cycle, at end of treatment and during clinical follow-up (Approx duration of study 3 years)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the serum concentration-time curve from time zero to time t (AUC(0-t)) for BMS-986012 (anti-fucosyl-GM1)</measure>
    <time_frame>At multiple timepoints during first 4 cycles then every 4th cycle, at end of treatment and during clinical follow-up (Approx duration of study 3 years)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the serum concentration-time curve in one dosing interval (AUC(TAU)) for BMS-986012 (anti-fucosyl-GM1)</measure>
    <time_frame>At multiple timepoints during first 4 cycles then every 4th cycle, at end of treatment and during clinical follow-up (Approx duration of study 3 years)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the serum concentration-time curve in one dosing interval (AUC(TAU)) for BMS-986012 (anti-fucosyl-GM1) in combination with Nivolumab</measure>
    <time_frame>At multiple timepoints during first 4 cycles then every 4th cycle, at end of treatment and during clinical follow-up (Approx duration of study 3 years)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Best overall response (BOR) for BMS-986012 (anti-fucosyl-GM1)</measure>
    <time_frame>Approximately every 6 weeks until disease progression or every 3-4 months for subjects with a confirmed response (Approx duration of study 3 years)</time_frame>
    <description>Best overall response (BOR): defined as the best response designation over the study as a whole, recorded between the dates of first dose until the last tumor assessment prior to subsequent therapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective Response Rate (ORR) for BMS-986012 (anti-fucosyl-GM1)</measure>
    <time_frame>Approximately every 6 weeks until disease progression or every 3-4 months for subjects with a confirmed response (Approx duration of study 3 years)</time_frame>
    <description>Objective Response Rate (ORR): defined as the total number of subjects whose best overall response (BOR) is either a complete response (CR) or partial response (PR) divided by the total number of subjects in the population of interest</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response for BMS-986012 (anti-fucosyl-GM1)</measure>
    <time_frame>Approximately every 6 weeks until disease progression or every 3-4 months for subjects with a confirmed response (Approx duration of study 3 years)</time_frame>
    <description>Duration of Response: defined as the time between the date of first response and the subsequent date of objectively documented disease progression or death, whichever occurs first</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival (PFS) for BMS-986012 (anti-fucosyl-GM1)</measure>
    <time_frame>Approximately every 6 weeks until disease progression or every 3-4 months for subjects with a confirmed response (Approx duration of study 3 years)</time_frame>
    <description>Progression Free Survival (PFS): defined as the time from the first dose of study medication to the date of the first objective documentation of tumor progression or death due to any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival Rate (PFSR) at week &quot;t&quot;; for BMS-986012 (anti-fucosyl-GM1)</measure>
    <time_frame>Approximately every 6 weeks until disease progression or every 3-4 months for subjects with a confirmed response (Approx duration of study 3 years)</time_frame>
    <description>Progression Free Survival Rate (PFSR) at week &quot;t&quot;: defined as the proportion of subjects who remain progression free and surviving at &quot;t&quot; weeks (t=12, 24, 36, etc)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS) for BMS-986012 (anti-fucosyl-GM1)</measure>
    <time_frame>Approximately every 6 weeks until disease progression or every 3-4 months for subjects with a confirmed response (Approx duration of study 3 years)</time_frame>
    <description>Overall Survival (OS): defined as the time between the date of first dose of study medication and the date of death. For subjects without documentation of death, OS will be censored on the last date the subject was known to be alive</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival Rate (OSR) at month &quot;t&quot; for BMS-986012 (anti-fucosyl-GM1)</measure>
    <time_frame>Approximately every 6 weeks until disease progression or every 3-4 months for subjects with a confirmed response (Approx duration of study 3 years)</time_frame>
    <description>Overall Survival Rate (OSR) at month &quot;t&quot;: defined as the proportion of subjects surviving at &quot;t&quot; months (eg, t=6, 12, 24 months, etc)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of specific anti-drug antibodies (ADA) to BMS-986012 every 3 weeks for first 3 cycles then every 4 cycles, at end of treatment and during clinical follow-up</measure>
    <time_frame>Every 3 weeks for first 3 cycles then every 4 cycles, at end of treatment and during clinical follow-up (Approx duration of study 3 years)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of specific anti-drug antibodies (ADA) to BMS-986012 in combination with Nivolumab every 3 weeks for first 3 cycles then every 4 cycles, at end of treatment and during clinical follow-up</measure>
    <time_frame>Every 3 weeks for first 3 cycles then every 4 cycles, at end of treatment and during clinical follow-up (Approx duration of study 3 years)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in the QTcF following administration of BMS-986012 at multiple timepoints during first cycle, then Day 1 of subsequent cycles and at end of treatment</measure>
    <time_frame>At multiple timepoints during first cycle, then Day 1 of subsequent cycles and at end of treatment (Approx duration of study 3 years)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in the QTcF following administration of BMS-986012 in combination with Nivolumab at multiple timepoints during first cycle, then Day 1 of subsequent cycles and at end of treatment</measure>
    <time_frame>At multiple timepoints during first cycle, then Day 1 of subsequent cycles and at end of treatment (Approx duration of study 3 years)</time_frame>
  </secondary_outcome>
  <number_of_arms>12</number_of_arms>
  <enrollment type="Actual">106</enrollment>
  <condition>Small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Dose Escalation (Monotherapy) Dose -1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Escalation (Monotherapy) Dose 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Escalation (Monotherapy) Dose 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Escalation (Monotherapy) Dose 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Escalation (Monotherapy) Dose 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Expansion (Monotherapy)- Cohort A (Refractory)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Expansion (Monotherapy) Cohort B (Refractory)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Expansion (Monotherapy) Cohort C (Sensitive)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Expansion (Monotherapy) Cohort D (Sensitive)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Escalation (Combination) Dose 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity in combination with Nivolumab specified dose on specified days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Escalation (Combination) Dose 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity in combination with Nivolumab specified dose on specified days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Expansion (Combination)- (Refractory and Sensitive)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity in combination with Nivolumab specified dose on specified days</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>BMS-986012 (anti-fucosyl-GM1)</intervention_name>
    <arm_group_label>Dose Escalation (Combination) Dose 1</arm_group_label>
    <arm_group_label>Dose Escalation (Combination) Dose 2</arm_group_label>
    <arm_group_label>Dose Escalation (Monotherapy) Dose -1</arm_group_label>
    <arm_group_label>Dose Escalation (Monotherapy) Dose 1</arm_group_label>
    <arm_group_label>Dose Escalation (Monotherapy) Dose 2</arm_group_label>
    <arm_group_label>Dose Escalation (Monotherapy) Dose 3</arm_group_label>
    <arm_group_label>Dose Escalation (Monotherapy) Dose 4</arm_group_label>
    <arm_group_label>Dose Expansion (Combination)- (Refractory and Sensitive)</arm_group_label>
    <arm_group_label>Dose Expansion (Monotherapy) Cohort B (Refractory)</arm_group_label>
    <arm_group_label>Dose Expansion (Monotherapy) Cohort C (Sensitive)</arm_group_label>
    <arm_group_label>Dose Expansion (Monotherapy) Cohort D (Sensitive)</arm_group_label>
    <arm_group_label>Dose Expansion (Monotherapy)- Cohort A (Refractory)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Nivolumab</intervention_name>
    <arm_group_label>Dose Escalation (Combination) Dose 1</arm_group_label>
    <arm_group_label>Dose Escalation (Combination) Dose 2</arm_group_label>
    <arm_group_label>Dose Expansion (Combination)- (Refractory and Sensitive)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        For more information regarding BMS clinical trial participation, please visit&#xD;
        www.BMSStudyConnect.com&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Histological or cytological confirmed small cell lung cancer (SCLC)&#xD;
&#xD;
          -  Performance Status 0-1&#xD;
&#xD;
          -  Adequate organ function&#xD;
&#xD;
          -  Measurable disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known or suspected brain metastasis&#xD;
&#xD;
          -  Small cell cancer not lung in origin&#xD;
&#xD;
          -  Significant or acute medical illness&#xD;
&#xD;
          -  Uncontrolled or significant cardiac disease&#xD;
&#xD;
          -  Infection&#xD;
&#xD;
          -  ≥ Grade 2 peripheral neuropathy&#xD;
&#xD;
          -  Concomitant malignancies&#xD;
&#xD;
          -  HIV related disease or known or suspected HIV+&#xD;
&#xD;
          -  Hepatitis B or C infection&#xD;
&#xD;
          -  ECG abnormalities as defined by the protocol&#xD;
&#xD;
          -  Allergies or hypersensitivities to monoclonal antibodies, BMS-986012 or related&#xD;
             compounds, including fucosyl-GM1 vaccine and Nivolumab&#xD;
&#xD;
        Other protocol defined inclusion/exclusion criteria could apply&#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_official>
    <last_name>Bristol-Myers Squibb</last_name>
    <role>Study Director</role>
    <affiliation>Bristol-Myers Squibb</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Nassau</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0001</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Forest Baptist Health</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>St. Leonards</city>
        <state>New South Wales</state>
        <zip>2065</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0011</name>
      <address>
        <city>Brisbane</city>
        <state>Queensland</state>
        <zip>4102</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Clayton</city>
        <state>Victoria</state>
        <zip>3168</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0015</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0012</name>
      <address>
        <city>Liege</city>
        <zip>4000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cross Cancer Institute</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 1Z2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nova Scotia Health Authority QEII Health Sciences Centre</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3H 2Y9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Juravinski Cancer Centre</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8V 5C2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0010</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 4L6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Health Network - Princess Margaret Cancer Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0008</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radboud Universitair Medisch Centrum</name>
      <address>
        <city>Nijmegen</city>
        <zip>6525 GA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0009</name>
      <address>
        <city>San Juan</city>
        <zip>00927</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Belgium</country>
    <country>Canada</country>
    <country>Korea, Republic of</country>
    <country>Netherlands</country>
    <country>Puerto Rico</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html</url>
    <description>BMS Clinical Trial Information</description>
  </link>
  <link>
    <url>https://www.bmsstudyconnect.com/us/en/home.html</url>
    <description>BMS Clinical Trial Patient Recruiting</description>
  </link>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>September 19, 2014</study_first_submitted>
  <study_first_submitted_qc>September 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>February 6, 2023</last_update_submitted>
  <last_update_submitted_qc>February 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 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>Lung Neoplasms</mesh_term>
    <mesh_term>Small Cell Lung Carcinoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nivolumab</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT02247349
org study id: CA001-030
secondary id: 2014-002372-89
nct id: NCT02247349
lead sponsor: 
has dmc: No
The purpose of this study is to determine the safety, tolerability, pharmacokinetics,
      immunogenicity, antitumor activity and pharmacodynamics of BMS-986012 alone and in
      combination with nivolumab in patients with relapsed/refractory SCLC.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Safety as measured by frequency of worst grade of adverse events (AEs), worst grade of serious adverse events (SAEs), incidence of adverse events leading to discontinuations, and deaths
time frame: Weekly for 1st and 2nd 21-day cycles, then once every 3 weeks during study treatment, at end of treatment and every 30 days during clinical follow-up until resolution of adverse events or 100 days after the last dose of study medication (Approx 3 years)
description: Safety as measured by frequency of worst grade of adverse events (AEs), worst grade of serious adverse events (SAEs), incidence of adverse events leading to discontinuations, and deaths graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), as appropriate
measure: Maximum observed serum concentration (Cmax) for BMS-986012 (anti-fucosyl-GM1)
time frame: At multiple timepoints during first 4 cycles then every 4th cycle, at end of treatment and during clinical follow-up (Approx duration of study 3 years)
measure: Maximum observed serum concentration (Cmax) for BMS-986012 (anti-fucosyl-GM1) in combination with Nivolumab
time frame: At multiple timepoints during first 4 cycles then every 4th cycle, at end of treatment and during clinical follow-up (Approx duration of study 3 years)
measure: Time of maximum observed serum concentration (Tmax) for BMS-986012 (anti-fucosyl-GM1)
time frame: At multiple timepoints during first 4 cycles then every 4th cycle, at end of treatment and during clinical follow-up (Approx duration of study 3 years)
measure: Time of maximum observed serum concentration (Tmax) for BMS-986012 (anti-fucosyl-GM1) in combination with Nivolumab
time frame: At multiple timepoints during first 4 cycles then every 4th cycle, at end of treatment and during clinical follow-up (Approx duration of study 3 years)
measure: Observed serum concentration at the end of a dosing interval (Ctau) for BMS-986012 (anti-fucosyl-GM1)
time frame: At multiple timepoints during first 4 cycles then every 4th cycle, at end of treatment and during clinical follow-up (Approx duration of study 3 years)
measure: Observed serum concentration at the end of a dosing interval (Ctau) for BMS-986012 (anti-fucosyl-GM1) in combination with Nivolumab
time frame: At multiple timepoints during first 4 cycles then every 4th cycle, at end of treatment and during clinical follow-up (Approx duration of study 3 years)
measure: Area under the serum concentration-time curve from time zero to time t (AUC(0-t)) for BMS-986012 (anti-fucosyl-GM1) in combination with Nivolumab
time frame: At multiple timepoints during first 4 cycles then every 4th cycle, at end of treatment and during clinical follow-up (Approx duration of study 3 years)
measure: Area under the serum concentration-time curve from time zero to time t (AUC(0-t)) for BMS-986012 (anti-fucosyl-GM1)
time frame: At multiple timepoints during first 4 cycles then every 4th cycle, at end of treatment and during clinical follow-up (Approx duration of study 3 years)
measure: Area under the serum concentration-time curve in one dosing interval (AUC(TAU)) for BMS-986012 (anti-fucosyl-GM1)
time frame: At multiple timepoints during first 4 cycles then every 4th cycle, at end of treatment and during clinical follow-up (Approx duration of study 3 years)
measure: Area under the serum concentration-time curve in one dosing interval (AUC(TAU)) for BMS-986012 (anti-fucosyl-GM1) in combination with Nivolumab
time frame: At multiple timepoints during first 4 cycles then every 4th cycle, at end of treatment and during clinical follow-up (Approx duration of study 3 years)
measure: Best overall response (BOR) for BMS-986012 (anti-fucosyl-GM1)
time frame: Approximately every 6 weeks until disease progression or every 3-4 months for subjects with a confirmed response (Approx duration of study 3 years)
description: Best overall response (BOR): defined as the best response designation over the study as a whole, recorded between the dates of first dose until the last tumor assessment prior to subsequent therapy
measure: Objective Response Rate (ORR) for BMS-986012 (anti-fucosyl-GM1)
time frame: Approximately every 6 weeks until disease progression or every 3-4 months for subjects with a confirmed response (Approx duration of study 3 years)
description: Objective Response Rate (ORR): defined as the total number of subjects whose best overall response (BOR) is either a complete response (CR) or partial response (PR) divided by the total number of subjects in the population of interest
measure: Duration of Response for BMS-986012 (anti-fucosyl-GM1)
time frame: Approximately every 6 weeks until disease progression or every 3-4 months for subjects with a confirmed response (Approx duration of study 3 years)
description: Duration of Response: defined as the time between the date of first response and the subsequent date of objectively documented disease progression or death, whichever occurs first
measure: Progression Free Survival (PFS) for BMS-986012 (anti-fucosyl-GM1)
time frame: Approximately every 6 weeks until disease progression or every 3-4 months for subjects with a confirmed response (Approx duration of study 3 years)
description: Progression Free Survival (PFS): defined as the time from the first dose of study medication to the date of the first objective documentation of tumor progression or death due to any cause
measure: Progression Free Survival Rate (PFSR) at week "t"; for BMS-986012 (anti-fucosyl-GM1)
time frame: Approximately every 6 weeks until disease progression or every 3-4 months for subjects with a confirmed response (Approx duration of study 3 years)
description: Progression Free Survival Rate (PFSR) at week "t": defined as the proportion of subjects who remain progression free and surviving at "t" weeks (t=12, 24, 36, etc)
measure: Overall Survival (OS) for BMS-986012 (anti-fucosyl-GM1)
time frame: Approximately every 6 weeks until disease progression or every 3-4 months for subjects with a confirmed response (Approx duration of study 3 years)
description: Overall Survival (OS): defined as the time between the date of first dose of study medication and the date of death. For subjects without documentation of death, OS will be censored on the last date the subject was known to be alive
measure: Overall Survival Rate (OSR) at month "t" for BMS-986012 (anti-fucosyl-GM1)
time frame: Approximately every 6 weeks until disease progression or every 3-4 months for subjects with a confirmed response (Approx duration of study 3 years)
description: Overall Survival Rate (OSR) at month "t": defined as the proportion of subjects surviving at "t" months (eg, t=6, 12, 24 months, etc)
measure: Occurrence of specific anti-drug antibodies (ADA) to BMS-986012 every 3 weeks for first 3 cycles then every 4 cycles, at end of treatment and during clinical follow-up
time frame: Every 3 weeks for first 3 cycles then every 4 cycles, at end of treatment and during clinical follow-up (Approx duration of study 3 years)
measure: Occurrence of specific anti-drug antibodies (ADA) to BMS-986012 in combination with Nivolumab every 3 weeks for first 3 cycles then every 4 cycles, at end of treatment and during clinical follow-up
time frame: Every 3 weeks for first 3 cycles then every 4 cycles, at end of treatment and during clinical follow-up (Approx duration of study 3 years)
measure: Changes in the QTcF following administration of BMS-986012 at multiple timepoints during first cycle, then Day 1 of subsequent cycles and at end of treatment
time frame: At multiple timepoints during first cycle, then Day 1 of subsequent cycles and at end of treatment (Approx duration of study 3 years)
measure: Changes in the QTcF following administration of BMS-986012 in combination with Nivolumab at multiple timepoints during first cycle, then Day 1 of subsequent cycles and at end of treatment
time frame: At multiple timepoints during first cycle, then Day 1 of subsequent cycles and at end of treatment (Approx duration of study 3 years)
arm group label: Dose Escalation (Monotherapy) Dose -1
arm group type: Experimental
description: BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity
arm group label: Dose Escalation (Monotherapy) Dose 1
arm group type: Experimental
description: BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity
arm group label: Dose Escalation (Monotherapy) Dose 2
arm group type: Experimental
description: BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity
arm group label: Dose Escalation (Monotherapy) Dose 3
arm group type: Experimental
description: BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity
arm group label: Dose Escalation (Monotherapy) Dose 4
arm group type: Experimental
description: BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity
arm group label: Dose Expansion (Monotherapy)- Cohort A (Refractory)
arm group type: Experimental
description: BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity
arm group label: Dose Expansion (Monotherapy) Cohort B (Refractory)
arm group type: Experimental
description: BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity
arm group label: Dose Expansion (Monotherapy) Cohort C (Sensitive)
arm group type: Experimental
description: BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity
arm group label: Dose Expansion (Monotherapy) Cohort D (Sensitive)
arm group type: Experimental
description: BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity
arm group label: Dose Escalation (Combination) Dose 1
arm group type: Experimental
description: BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity in combination with Nivolumab specified dose on specified days
arm group label: Dose Escalation (Combination) Dose 2
arm group type: Experimental
description: BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity in combination with Nivolumab specified dose on specified days
arm group label: Dose Expansion (Combination)- (Refractory and Sensitive)
arm group type: Experimental
description: BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity in combination with Nivolumab specified dose on specified days
intervention type: Biological
intervention name: BMS-986012 (anti-fucosyl-GM1)
arm group label: Dose Escalation (Combination) Dose 1
arm group label: Dose Escalation (Combination) Dose 2
arm group label: Dose Escalation (Monotherapy) Dose -1
arm group label: Dose Escalation (Monotherapy) Dose 1
arm group label: Dose Escalation (Monotherapy) Dose 2
arm group label: Dose Escalation (Monotherapy) Dose 3
arm group label: Dose Escalation (Monotherapy) Dose 4
arm group label: Dose Expansion (Combination)- (Refractory and Sensitive)
arm group label: Dose Expansion (Monotherapy) Cohort B (Refractory)
arm group label: Dose Expansion (Monotherapy) Cohort C (Sensitive)
arm group label: Dose Expansion (Monotherapy) Cohort D (Sensitive)
arm group label: Dose Expansion (Monotherapy)- Cohort A (Refractory)
intervention type: Biological
intervention name: Nivolumab
arm group label: Dose Escalation (Combination) Dose 1
arm group label: Dose Escalation (Combination) Dose 2
arm group label: Dose Expansion (Combination)- (Refractory and Sensitive)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bristol-Myers Squibb
role: Study Director
affiliation: Bristol-Myers Squibb
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country: Australia
country: Belgium
country: Canada
country: Korea, Republic of
country: Netherlands
country: Puerto Rico
country: United States
url: https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
description: BMS Clinical Trial Information
url: https://www.bmsstudyconnect.com/us/en/home.html
description: BMS Clinical Trial Patient Recruiting
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Small Cell Lung Carcinoma
mesh term: Nivolumab