<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/NCT04472806</url>
  </required_header>
  <id_info>
    <org_study_id>ZLuo</org_study_id>
    <nct_id>NCT04472806</nct_id>
  </id_info>
  <brief_title>Maintenance Treatment of Toripalimab(JS001) in Patients With Unresectable Locally Advanced or Metastatic Mucosal Melanoma</brief_title>
  <acronym>MTAM</acronym>
  <official_title>A Multicenter, Single-arm, Open, Phase II Clinical Study on the Efficacy and Safety of Toripalimab(JS001) After Chemotherapy in Combination With Endostar in Patients With Unresectable Locally Advanced or Metastatic Mucosal Melanoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fudan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Zhejiang Cancer Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fujian Cancer Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fudan University</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 study is a multicenter, single-arm, open, phase Ⅱ clinical study to evaluate the safety&#xD;
      and efficacy of Toripalimab(JS001) monoclonal injection after chemotherapy in combination&#xD;
      with Endostar for Locally Advanced or Metastatic Mucosal Melanoma.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 20, 2020</start_date>
  <completion_date type="Anticipated">June 20, 2023</completion_date>
  <primary_completion_date type="Anticipated">June 20, 2022</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Progression-Free Survival, PFS</measure>
    <time_frame>Approximately 1 years</time_frame>
    <description>PFS is defined as the time from the date of first treatment to the first occurrence of disease progression or death from any cause.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Objective Response Rate, ORR</measure>
    <time_frame>Approximately 2 years</time_frame>
    <description>ORR is defined as the proportion of patients with a complete response (CR) or partial response (PR) on two consecutive occasions &gt;= 4 weeks apart, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival, OS</measure>
    <time_frame>Approximately 2 years</time_frame>
    <description>OS is defined as the time from the date of first treatment to death from any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of AEs/SAEs</measure>
    <time_frame>Approximately 2 years</time_frame>
    <description>Percentage of Participants With Adverse Events/Severe Adverse Events</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">31</enrollment>
  <condition>Mucosal Melanoma</condition>
  <arm_group>
    <arm_group_label>chemotherapy+Endostar+Toripalimab(JS001)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Toripalimab</intervention_name>
    <description>Toripalimab, humanized anti-PD-1 monoclonal antibody is a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, which selectively interferes with the combination of PD-1 with its ligands, PD-L1 and PD-L2, resulting in the activation of lymphocytes and elimination of malignancy theoretically.&#xD;
Toripalimab treatment after chemotherapy in combination with Endostar, 240 mg, Q3W, up to 2 years.</description>
    <arm_group_label>chemotherapy+Endostar+Toripalimab(JS001)</arm_group_label>
    <other_name>JS001</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>chemotherapy in combination with Endostar</intervention_name>
    <description>chemotherapy+ Endostar</description>
    <arm_group_label>chemotherapy+Endostar+Toripalimab(JS001)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 18-75 years, male or female；&#xD;
&#xD;
          2. Histopathologically confirmed and diagnosed as mucosal melanoma;&#xD;
&#xD;
          3. ECOG score 0 or 1;&#xD;
&#xD;
          4. Life expectancy of at least 12 weeks；&#xD;
&#xD;
          5. SD/PR/CR after chemotherapy in combination with Endostar;&#xD;
&#xD;
          6. No contraindications, having adequate organ and marrow function；&#xD;
&#xD;
          7. Use of highly-effective contraceptive methods during the whole study for men of&#xD;
             reproduction ability or women of childbearing potential (e.g. oral contraceptives,&#xD;
             intrauterine contraceptive device, abstinence of sexual intercourse or barrier&#xD;
             contraception in combination with spermatocide), and continuation of contraception for&#xD;
             12 months after the end of treatment；&#xD;
&#xD;
          8. The subject is voluntary to participate in the study, sign the informed consent form,&#xD;
             with good compliance and willingness to cooperate with follow-up.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Previously treated with anti-PD-1, anti-PD-L1, anti-PD-L2;&#xD;
&#xD;
          2. Known allergy to recombinant humanized anti-PD-1 monoclonal antibody drug and its&#xD;
             components;&#xD;
&#xD;
          3. Skin melanoma, eye melanoma, melanoma with unknown primary foci;&#xD;
&#xD;
          4. Symptomatic brain or meningeal metastases, unless the patient has been treated for &gt; 6&#xD;
             months, the imaging results are negative within 4 weeks before entering the study, and&#xD;
             the clinical symptoms associated with the tumor are stable at the time of entering the&#xD;
             study;&#xD;
&#xD;
          5. Female patients who are pregnant or lactating, or of childbearing potential but not&#xD;
             using appropriate contraceptive measures;&#xD;
&#xD;
          6. Currently having serious and uncontrolled acute infection; or suppurative infection&#xD;
             and chronic infection with prolonged wound healing;&#xD;
&#xD;
          7. Having serious heart disorder, including cardiac failure congestive, uncontrollable&#xD;
             high-risk arrhythmia, unstable angina pectoris, infarct myocardial, severe cardiac&#xD;
             valve disease and refractory hypertension;&#xD;
&#xD;
          8. Having neurological, mental disease or mental disorder that can not be easily&#xD;
             controlled, poor compliance, inability to cooperate and narrate therapeutic response;&#xD;
&#xD;
          9. Patients with other malignant tumors at the same time;&#xD;
&#xD;
         10. Patients participated in other clinical trials at the same time;&#xD;
&#xD;
         11. Positive HIV; positive HCV; positive HBsAg or HBcAb whilst positive HBV DNA copies&#xD;
             detected (limit of quantitation 500 IU/mL);&#xD;
&#xD;
         12. Active autoimmune diseases requiring systemic treatment in the past two years (e.g.,&#xD;
             use of disease-regulating drug, corticosteroid or immunosuppressant), relevant&#xD;
             replacement therapy is allowed (e.g., thyroxine, insulin or physiological&#xD;
             corticosteroid replacement therapy for renal or pituitary insufficiency);&#xD;
&#xD;
         13. Having received live vaccine within 4 weeks prior to the start of treatment;&#xD;
&#xD;
         14. Other severe, acute or chronic medical diseases or mental diseases or abnormalities in&#xD;
             laboratory examination possibly increasing the relevant risk in study participation or&#xD;
             possibly interfering the interpretation of study results as judged by the&#xD;
             investigators.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Zhiguo Luo</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhiguo Luo, MD,PhD</last_name>
      <phone>862164175590</phone>
      <phone_ext>8908</phone_ext>
      <email>luozhiguo88@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>July 12, 2020</last_update_submitted>
  <last_update_submitted_qc>July 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 15, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fudan University</investigator_affiliation>
    <investigator_full_name>Zhiguo Luo, MD, PhD</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </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>Endostar protein</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04472806
org study id: ZLuo
nct id: NCT04472806
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is a multicenter, single-arm, open, phase Ⅱ clinical study to evaluate the safety
      and efficacy of Toripalimab(JS001) monoclonal injection after chemotherapy in combination
      with Endostar for Locally Advanced or Metastatic Mucosal Melanoma.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression-Free Survival, PFS
time frame: Approximately 1 years
description: PFS is defined as the time from the date of first treatment to the first occurrence of disease progression or death from any cause.
measure: Objective Response Rate, ORR
time frame: Approximately 2 years
description: ORR is defined as the proportion of patients with a complete response (CR) or partial response (PR) on two consecutive occasions >= 4 weeks apart, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1).
measure: Overall Survival, OS
time frame: Approximately 2 years
description: OS is defined as the time from the date of first treatment to death from any cause.
measure: Incidence of AEs/SAEs
time frame: Approximately 2 years
description: Percentage of Participants With Adverse Events/Severe Adverse Events
arm group label: chemotherapy+Endostar+Toripalimab(JS001)
arm group type: Experimental
intervention type: Drug
intervention name: Toripalimab
description: Toripalimab, humanized anti-PD-1 monoclonal antibody is a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, which selectively interferes with the combination of PD-1 with its ligands, PD-L1 and PD-L2, resulting in the activation of lymphocytes and elimination of malignancy theoretically.
Toripalimab treatment after chemotherapy in combination with Endostar, 240 mg, Q3W, up to 2 years.
arm group label: chemotherapy+Endostar+Toripalimab(JS001)
other name: JS001
intervention type: Drug
intervention name: chemotherapy in combination with Endostar
description: chemotherapy+ Endostar
arm group label: chemotherapy+Endostar+Toripalimab(JS001)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Fudan University
investigator full name: Zhiguo Luo, MD, PhD
investigator title: Clinical Professor
mesh term: Melanoma
mesh term: Endostar protein
sharing ipd: Undecided