<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/NCT03777579</url>
  </required_header>
  <id_info>
    <org_study_id>NABP201801</org_study_id>
    <nct_id>NCT03777579</nct_id>
  </id_info>
  <brief_title>A Study of First-line JS001 and Nab-paclitaxel Versus Palcelbo and Nab-Paclitaxel in Participants With Advanced Recurrent or Metastatic TNBC</brief_title>
  <official_title>A Phase III, Multicenter, Randomized, Placebo-Controlled Study of JS001 (Anti-PD-1 Antibody) in Combination With Nab-Paclitaxel Compared With Placebo With Nab-Paclitaxel as First-line Therapy for Patients With Primarily Diagnose or Recurrent and Metastatic Triple-Negative Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CSPC ZhongQi Pharmaceutical Technology Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>CSPC ZhongQi Pharmaceutical Technology Co., Ltd.</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This multicenter, randomized, double-blind study will evaluate the efficacy, safety of JS001&#xD;
      administered with nab-paclitaxel compared with placebo in combination with nab-paclitaxel as&#xD;
      first-line therapy in participants with primarily diagnosed stage IV and recurrent or&#xD;
      metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy&#xD;
      for metastatic breast cancer (mBC).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    trial handovered to another sponser.&#xD;
  </why_stopped>
  <start_date type="Actual">December 21, 2018</start_date>
  <completion_date type="Anticipated">July 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2019</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Progression-Free Survival (PFS) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)by Independent Review Committee (IRC)</measure>
    <time_frame>From Day 1 to disease progression (PD) or death from any cause, assessed up to end of study (up to approximately 30 months)</time_frame>
    <description>PFS is defined as the time from randomization to the first occurrence of PD, as determined by the investigator using RECIST v1.1, or death from any cause during the study, whichever occurs first. PD is defined as greater than or equal to (&gt;/=) 20 percent (%) relative increase and &gt;/=5 millimeter (mm) of absolute increase in the sum of diameters (SD) of target lesions (TLs), taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression-Free Survival (PFS) Assessed Using RECIST v1.1 by investigator</measure>
    <time_frame>From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 30 months)</time_frame>
    <description>PFS is defined as the time from randomization to the first occurrence of PD, as determined by the investigator using RECIST v1.1, or death from any cause during the study, whichever occurs first. PD is defined as greater than or equal to (&gt;/=) 20 percent (%) relative increase and &gt;/=5 millimeter (mm) of absolute increase in the sum of diameters (SD) of target lesions (TLs), taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective response rate (ORR) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)by IRC</measure>
    <time_frame>From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 30 months)</time_frame>
    <description>ORR is defined as the rate of CR or PR, as determined by IRC using RECIST v1.1 criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of response (DoR) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)by IRC</measure>
    <time_frame>From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 30 months)</time_frame>
    <description>DoR is defined as the time period from the date of initial CR or PR until the date of PD or death from any cause, whichever occurs first.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease control rate (DCR) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)by IRC</measure>
    <time_frame>From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 30 months)</time_frame>
    <description>DCR is defined as the rate of of CR, PR, or stable disease according to RECIST v1.1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months)</time_frame>
    <description>OS is defined as the time from randomization to death from any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>OS rate at 12 months</measure>
    <time_frame>the percent of participants that are alive at 12months from Day 1.</time_frame>
    <description>OS is defined as the time from randomization to death from any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>OS rate at 24 months</measure>
    <time_frame>the percent of participants that are alive at 24 months from Day 1.</time_frame>
    <description>OS is defined as the time from randomization to death from any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PFS Assessed Using immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) by investigator</measure>
    <time_frame>From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months)</time_frame>
    <description>Progression is confirmed in the target lesion category if the next imaging assessment after iUPD (4-8 weeks later) confirms a further increase in sum of measures of target disease from iUPD, with an increase of at least 5mm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ORR Assessed Using immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) by investigator</measure>
    <time_frame>From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months)</time_frame>
    <description>ORR is defined as the rate of iCR or iPR, as determined by investigator using iRECIST criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DoR Assessed Using immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) by investigator</measure>
    <time_frame>From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months)</time_frame>
    <description>DoR is defined as the time period from the date of initial iCR or iPR until the date of iCPD or death from any cause, whichever occurs first.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DCR Assessed Using immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) by investigator</measure>
    <time_frame>From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months)</time_frame>
    <description>DCR is defined as the rate of of iCR, iPR, or stable disease according to iRECIST.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage and severity of Participants With Adverse Events (AEs)</measure>
    <time_frame>From Day 1 to 60 days after last dose of study drug, assessed up to end of study (up to approximately 30 months)</time_frame>
    <description>percentage and CTC AE(v5.0) of AEs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Anti-Drug Antibodies (ATAs)</measure>
    <time_frame>Pre-dose (60minutes±10minutes) on Day 1 of Cycles 1, 3, 5, 7, 9 and at every 6 cycles thereafter until disease progression, at disease progression. (maximum up to 30 months) (1 Cycle = 21 days)</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">375</enrollment>
  <condition>Triple Negative Breast Cancer</condition>
  <arm_group>
    <arm_group_label>JS001 Plus Nab-Paclitaxel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants assigned to JS001 plus nab-paclitaxel will receive both agents until disease progression or unacceptable toxicity.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Plus Nab-Paclitaxel</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants assigned to placebo plus nab-paclitaxel will receive both agents until disease progression or unacceptable toxicity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>JS001，an engineered anti-PD-1 antibody</intervention_name>
    <description>JS001 at a fixed dose of 240 milligrams via intravenous (IV) infusion on Days 1 of each 21-day cycle until disease progression or unacceptable toxicity.</description>
    <arm_group_label>JS001 Plus Nab-Paclitaxel</arm_group_label>
    <other_name>Terepril monoclonal antibody</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nab-Paclitaxel</intervention_name>
    <description>Nab-Paclitaxel at a starting dose of 125mg per square meter via IV infusion on Days 1, 8 of each 21-day cycle. Nab-Paclitaxel will be administered until disease progression or unacceptable toxicity.</description>
    <arm_group_label>JS001 Plus Nab-Paclitaxel</arm_group_label>
    <arm_group_label>Placebo Plus Nab-Paclitaxel</arm_group_label>
    <other_name>Paclitaxel For Injection（Albumin Bound）</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo administered via intravenous (IV) infusion on Days 1 of each 21-day cycle until disease progression or unacceptable toxicity.</description>
    <arm_group_label>Placebo Plus Nab-Paclitaxel</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Primarily diagnosed stage IV or recurrent and metastatic, histologically documented&#xD;
             TNBC characterized by absence of human epidermal growth factor 2 (HER2), estrogen&#xD;
             receptor (ER), and progesterone receptor (PR) expression;&#xD;
&#xD;
          2. No prior chemotherapy or targeted systemic therapy for inoperable stage IV or&#xD;
             metastatic TNBC；&#xD;
&#xD;
          3. Eligible for taxane monotherapy；&#xD;
&#xD;
          4. Eastern Cooperative Oncology Group performance status of 0 or 1；&#xD;
&#xD;
          5. Measurable disease as defined by RECIST v1.1；&#xD;
&#xD;
          6. Adequate hematologic and end-organ function。&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Known central nervous system (CNS) disease with active syndrome or untreated disease,&#xD;
             except for treated asymptomatic CNS metastases；&#xD;
&#xD;
          2. History of autoimmune disease；&#xD;
&#xD;
          3. History of Anaphylaxis to PD-(L)1 antibody or CTLA-4 antibody or paclitaxel;&#xD;
&#xD;
          4. Prior allogeneic stem cell or solid organ transplantation;&#xD;
&#xD;
          5. Active hepatitis B or hepatitis C;&#xD;
&#xD;
          6. Positive of HIV antibody.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>JIANG ZE FEI, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beijing 302 Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The fifth medical center of PLA general hospital</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 12, 2018</study_first_submitted>
  <study_first_submitted_qc>December 13, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 17, 2018</study_first_posted>
  <last_update_submitted>August 6, 2019</last_update_submitted>
  <last_update_submitted_qc>August 6, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 8, 2019</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>Breast Neoplasms</mesh_term>
    <mesh_term>Triple Negative Breast Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paclitaxel</mesh_term>
    <mesh_term>Albumin-Bound Paclitaxel</mesh_term>
    <mesh_term>Antibodies</mesh_term>
    <mesh_term>Immunoglobulins</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03777579
org study id: NABP201801
nct id: NCT03777579
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This multicenter, randomized, double-blind study will evaluate the efficacy, safety of JS001
      administered with nab-paclitaxel compared with placebo in combination with nab-paclitaxel as
      first-line therapy in participants with primarily diagnosed stage IV and recurrent or
      metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy
      for metastatic breast cancer (mBC).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Progression-Free Survival (PFS) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)by Independent Review Committee (IRC)
time frame: From Day 1 to disease progression (PD) or death from any cause, assessed up to end of study (up to approximately 30 months)
description: PFS is defined as the time from randomization to the first occurrence of PD, as determined by the investigator using RECIST v1.1, or death from any cause during the study, whichever occurs first. PD is defined as greater than or equal to (>/=) 20 percent (%) relative increase and >/=5 millimeter (mm) of absolute increase in the sum of diameters (SD) of target lesions (TLs), taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions.
measure: Progression-Free Survival (PFS) Assessed Using RECIST v1.1 by investigator
time frame: From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 30 months)
description: PFS is defined as the time from randomization to the first occurrence of PD, as determined by the investigator using RECIST v1.1, or death from any cause during the study, whichever occurs first. PD is defined as greater than or equal to (>/=) 20 percent (%) relative increase and >/=5 millimeter (mm) of absolute increase in the sum of diameters (SD) of target lesions (TLs), taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions.
measure: Objective response rate (ORR) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)by IRC
time frame: From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 30 months)
description: ORR is defined as the rate of CR or PR, as determined by IRC using RECIST v1.1 criteria.
measure: Duration of response (DoR) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)by IRC
time frame: From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 30 months)
description: DoR is defined as the time period from the date of initial CR or PR until the date of PD or death from any cause, whichever occurs first.
measure: Disease control rate (DCR) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)by IRC
time frame: From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 30 months)
description: DCR is defined as the rate of of CR, PR, or stable disease according to RECIST v1.1.
measure: Overall Survival (OS)
time frame: From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months)
description: OS is defined as the time from randomization to death from any cause.
measure: OS rate at 12 months
time frame: the percent of participants that are alive at 12months from Day 1.
description: OS is defined as the time from randomization to death from any cause.
measure: OS rate at 24 months
time frame: the percent of participants that are alive at 24 months from Day 1.
description: OS is defined as the time from randomization to death from any cause.
measure: PFS Assessed Using immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) by investigator
time frame: From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months)
description: Progression is confirmed in the target lesion category if the next imaging assessment after iUPD (4-8 weeks later) confirms a further increase in sum of measures of target disease from iUPD, with an increase of at least 5mm.
measure: ORR Assessed Using immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) by investigator
time frame: From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months)
description: ORR is defined as the rate of iCR or iPR, as determined by investigator using iRECIST criteria.
measure: DoR Assessed Using immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) by investigator
time frame: From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months)
description: DoR is defined as the time period from the date of initial iCR or iPR until the date of iCPD or death from any cause, whichever occurs first.
measure: DCR Assessed Using immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) by investigator
time frame: From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months)
description: DCR is defined as the rate of of iCR, iPR, or stable disease according to iRECIST.
measure: Percentage and severity of Participants With Adverse Events (AEs)
time frame: From Day 1 to 60 days after last dose of study drug, assessed up to end of study (up to approximately 30 months)
description: percentage and CTC AE(v5.0) of AEs
measure: Percentage of Participants With Anti-Drug Antibodies (ATAs)
time frame: Pre-dose (60minutes±10minutes) on Day 1 of Cycles 1, 3, 5, 7, 9 and at every 6 cycles thereafter until disease progression, at disease progression. (maximum up to 30 months) (1 Cycle = 21 days)
arm group label: JS001 Plus Nab-Paclitaxel
arm group type: Experimental
description: Participants assigned to JS001 plus nab-paclitaxel will receive both agents until disease progression or unacceptable toxicity.
arm group label: Placebo Plus Nab-Paclitaxel
arm group type: Placebo Comparator
description: Participants assigned to placebo plus nab-paclitaxel will receive both agents until disease progression or unacceptable toxicity.
intervention type: Drug
intervention name: JS001，an engineered anti-PD-1 antibody
description: JS001 at a fixed dose of 240 milligrams via intravenous (IV) infusion on Days 1 of each 21-day cycle until disease progression or unacceptable toxicity.
arm group label: JS001 Plus Nab-Paclitaxel
other name: Terepril monoclonal antibody
intervention type: Drug
intervention name: Nab-Paclitaxel
description: Nab-Paclitaxel at a starting dose of 125mg per square meter via IV infusion on Days 1, 8 of each 21-day cycle. Nab-Paclitaxel will be administered until disease progression or unacceptable toxicity.
arm group label: JS001 Plus Nab-Paclitaxel
arm group label: Placebo Plus Nab-Paclitaxel
other name: Paclitaxel For Injection（Albumin Bound）
intervention type: Drug
intervention name: Placebo
description: Placebo administered via intravenous (IV) infusion on Days 1 of each 21-day cycle until disease progression or unacceptable toxicity.
arm group label: Placebo Plus Nab-Paclitaxel
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: JIANG ZE FEI, PHD
role: Principal Investigator
affiliation: Beijing 302 Hospital
facility: 
country: China
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Triple Negative Breast Neoplasms
mesh term: Paclitaxel
mesh term: Albumin-Bound Paclitaxel
mesh term: Antibodies
mesh term: Immunoglobulins
sharing ipd: No