<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/NCT04486391</url>
  </required_header>
  <id_info>
    <org_study_id>BGB-A317-314</org_study_id>
    <secondary_id>CTR20201517</secondary_id>
    <nct_id>NCT04486391</nct_id>
  </id_info>
  <brief_title>Tislelizumab Monotherapy Versus Salvage Chemotherapy for Relapsed/Refractory Classical Hodgkin Lymphoma</brief_title>
  <official_title>A Multicenter, Open-Label, Randomized Controlled Phase 3 Study of Tislelizumab Monotherapy Versus Salvage Chemotherapy in Patients With Relapsed/Refractory Classical Hodgkin Lymphoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>BeiGene</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>BeiGene</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>
      The primary objective of this study is to evaluate the efficacy of tislelizumab in&#xD;
      participants with relapsed or refractory classical Hodgkin lymphoma (cHL), as measured by&#xD;
      Progression-free Survival (PFS) as assessed by investigator&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Anticipated">March 26, 2025</completion_date>
  <primary_completion_date type="Anticipated">September 26, 2024</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Progression-free Survival (PFS) by Investigator</measure>
    <time_frame>Up to 45 months</time_frame>
    <description>Time from the date of randomization to the date of progressive disease (PD) or death, whichever occurs first</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of Response (DOR) by Investigator</measure>
    <time_frame>Up to 45 months</time_frame>
    <description>The time from the date that response criteria are first met to the date that PD is objectively documented or death, whichever occurs first</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Response Rate (ORR) by Investigator</measure>
    <time_frame>Up to 45 months</time_frame>
    <description>The proportion of participants who achieves a best overall response of complete response (CR) or partial response (PR)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Complete Response (CR) by Investigator</measure>
    <time_frame>Up to 45 months</time_frame>
    <description>The proportion of participants who achieves a best overall response of CR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Response (TTR) by Investigator</measure>
    <time_frame>Up to 45 months</time_frame>
    <description>Time from the date of randomization to the time the response criteria are first met</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>Up to 45 months</time_frame>
    <description>Defined as the time from the date of randomization to the date of death due to any reason</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants experiencing Adverse Events (AEs)</measure>
    <time_frame>Up to 45 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants experiencing Serious Adverse Events (SAEs)</measure>
    <time_frame>Up to 45 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">123</enrollment>
  <condition>Classical Hodgkin Lymphoma</condition>
  <arm_group>
    <arm_group_label>Tislelizumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tislelizumab monotherapy for up to 45 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Salvage chemotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Salvage chemotherapy for up to 45 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tislelizumab</intervention_name>
    <description>200 mg administered via intravenous (IV) infusion once every 3 weeks</description>
    <arm_group_label>Tislelizumab</arm_group_label>
    <other_name>BGB-A317</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Salvage Chemotherapy</intervention_name>
    <description>Salvage chemotherapy administered as assessed as appropriate by the investigator in accordance with the local guideline, including but not limited to DHAP (dexamethasone, cisplatin, high-dose cytarabine), ESHAP (etoposide, methylprednisolone, high-dose cytarabine and cisplatin), DICE (dexamethasone, ifosfamide, carboplatin, etoposide), ICE (ifosfamide, carboplatin, etoposide), IGEV (ifosfamide, gemcitabine, vinorelbine, prednisone), GVD (gemcitabine, vinorelbine, liposomal doxorubicin), and MINE (etoposide, ifosfamide, mesna, mitoxantrone)</description>
    <arm_group_label>Salvage chemotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
        1. Histologically confirmed cHL.Must have relapsed or refractory ( cHL and&#xD;
&#xD;
          1. Has failed to achieve a response or progressed after autologous hematopoietic stem&#xD;
             cell transplant (ASCT). or&#xD;
&#xD;
          2. Has received at least two prior lines of systemic chemotherapies for cHL and is not an&#xD;
             ASCT candidate.&#xD;
&#xD;
             2. Must have measurable disease 3. Eastern Cooperative Oncology Group (ECOG)&#xD;
             performance status of 0 or 1.&#xD;
&#xD;
             4. Must have adequate organ functions. 5. Prior chemotherapy, radiotherapy,&#xD;
             immunotherapy or investigational therapy used to control cancer including locoregional&#xD;
             treatment must have been completed ≥ 4 weeks before the first dose of study drug, and&#xD;
             all treatment-related adverse events are stable and have either returned to baseline&#xD;
             or Grade 0/1&#xD;
&#xD;
             Key Exclusion Criteria:&#xD;
&#xD;
               1. Nodular lymphocyte-predominant Hodgkin lymphoma or gray zone lymphoma. Known&#xD;
                  central nervous system (CNS) lymphoma.&#xD;
&#xD;
               2. Prior allogeneic hematopoietic stem cell transplant. ASCT or Chimeric Antigen&#xD;
                  Receptor T-Cell Immunotherapy (CAR-T) within 100 days of first dose of study&#xD;
                  drug.&#xD;
&#xD;
               3. Prior therapies targeting PD-1 or PD-L1.&#xD;
&#xD;
               4. Prior malignancy within the past 3 years except for curatively treated basal or&#xD;
                  squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of&#xD;
                  the cervix or breast.&#xD;
&#xD;
               5. Participant with active autoimmune disease or history of autoimmune disease with&#xD;
                  high risk of recurrence.&#xD;
&#xD;
               6. Serious acute or chronic infection requiring systemic therapy.&#xD;
&#xD;
               7. Known human immunodeficiency virus (HIV), or serologic status reflecting active&#xD;
                  hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.&#xD;
&#xD;
             NOTE: Other protocol defined Inclusion/Exclusion criteria may 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>Xia Zhao, MD</last_name>
    <role>Study Director</role>
    <affiliation>BeiGene</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>BeiGene</last_name>
    <phone>1-877-828-5568</phone>
    <email>clinicaltrials@beigene.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Beijing Cancer Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100142</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Quanzhou First Affliated Hospital of Fujian Medical University</name>
      <address>
        <city>Quanzhou</city>
        <state>Fujian</state>
        <zip>362000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Harbin Medical University Cancer Hospital</name>
      <address>
        <city>Harbin</city>
        <state>Heilongjiang</state>
        <zip>150000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Henan Cancer Hospital</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <zip>450000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hunan Cancer Hospital</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410013</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Jilin Cancer Hospital</name>
      <address>
        <city>Changchun</city>
        <state>Jilin</state>
        <zip>130021</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Zhejiang Cancer Hospital</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310022</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>July 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>July 25, 2023</last_update_submitted>
  <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 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>Lymphoma</mesh_term>
    <mesh_term>Hodgkin Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tislelizumab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</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/NCT04486391
org study id: BGB-A317-314
secondary id: CTR20201517
nct id: NCT04486391
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary objective of this study is to evaluate the efficacy of tislelizumab in
      participants with relapsed or refractory classical Hodgkin lymphoma (cHL), as measured by
      Progression-free Survival (PFS) as assessed by investigator
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression-free Survival (PFS) by Investigator
time frame: Up to 45 months
description: Time from the date of randomization to the date of progressive disease (PD) or death, whichever occurs first
measure: Duration of Response (DOR) by Investigator
time frame: Up to 45 months
description: The time from the date that response criteria are first met to the date that PD is objectively documented or death, whichever occurs first
measure: Overall Response Rate (ORR) by Investigator
time frame: Up to 45 months
description: The proportion of participants who achieves a best overall response of complete response (CR) or partial response (PR)
measure: Rate of Complete Response (CR) by Investigator
time frame: Up to 45 months
description: The proportion of participants who achieves a best overall response of CR
measure: Time to Response (TTR) by Investigator
time frame: Up to 45 months
description: Time from the date of randomization to the time the response criteria are first met
measure: Overall survival (OS)
time frame: Up to 45 months
description: Defined as the time from the date of randomization to the date of death due to any reason
measure: Number of participants experiencing Adverse Events (AEs)
time frame: Up to 45 months
measure: Number of participants experiencing Serious Adverse Events (SAEs)
time frame: Up to 45 months
arm group label: Tislelizumab
arm group type: Experimental
description: Tislelizumab monotherapy for up to 45 months
arm group label: Salvage chemotherapy
arm group type: Experimental
description: Salvage chemotherapy for up to 45 months
intervention type: Drug
intervention name: Tislelizumab
description: 200 mg administered via intravenous (IV) infusion once every 3 weeks
arm group label: Tislelizumab
other name: BGB-A317
intervention type: Drug
intervention name: Salvage Chemotherapy
description: Salvage chemotherapy administered as assessed as appropriate by the investigator in accordance with the local guideline, including but not limited to DHAP (dexamethasone, cisplatin, high-dose cytarabine), ESHAP (etoposide, methylprednisolone, high-dose cytarabine and cisplatin), DICE (dexamethasone, ifosfamide, carboplatin, etoposide), ICE (ifosfamide, carboplatin, etoposide), IGEV (ifosfamide, gemcitabine, vinorelbine, prednisone), GVD (gemcitabine, vinorelbine, liposomal doxorubicin), and MINE (etoposide, ifosfamide, mesna, mitoxantrone)
arm group label: Salvage chemotherapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Xia Zhao, MD
role: Study Director
affiliation: BeiGene
last name: BeiGene
phone: 1-877-828-5568
email: clinicaltrials@beigene.com
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
country: China
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Hodgkin Disease
mesh term: Tislelizumab
sharing ipd: Yes