<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/NCT04444193</url>
  </required_header>
  <id_info>
    <org_study_id>SHFMIH-IIT-2020-0005</org_study_id>
    <nct_id>NCT04444193</nct_id>
  </id_info>
  <brief_title>Durvalumab and Lenvatinib in Participants With Advanced and Recurrent Endometrial Carcinoma</brief_title>
  <acronym>Dulect2020-2</acronym>
  <official_title>Safety and Efficacy Study of Durvalumab in Combination With Lenvatinib in Participants With Advanced and Recurrent Endometrial Carcinoma--DULECT Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai First Maternity and Infant Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai First Maternity and Infant Hospital</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 study will evaluate the safety and efficacy of durvalumab in combination with lenvatinib&#xD;
      in participants with advanced and recurrent endometrial carcinoma.The primary hypothesis of&#xD;
      this study are that patients with advanced and recurrent endometrial carcinoma could benefit&#xD;
      from durvalumab plus lenvatinib with respect to: 1)Progression Free Survival (PFS) ; 2)&#xD;
      Objective Response Rate (ORR); and Overall survival (OS). The investigators design a clinical&#xD;
      study to explore whether the combination above as a treatment in patients with advanced and&#xD;
      recurrent endometrial carcinoma could prolong PFS and to analyze potential immune biomarker&#xD;
      of therapeutic response.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The combination of Lenvatinib and Programmed death-ligand 1 (PD-L1) blocking has great&#xD;
      potential in the treatment of advanced and recurrent endometrial cancer. This trial is&#xD;
      designed as a prospective, open label study for 20 patients with advanced (recurrent,&#xD;
      refractory or metastatic) endometrial cancer, including carcinosarcoma of the uterus. The aim&#xD;
      is to investigate the efficacy of the combination therapy of Lenvatinib 80-120mg daily orally&#xD;
      and durvalumab 1500mg by IV infusion every 4 weeks in terms of progression free survival.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 31, 2020</start_date>
  <completion_date type="Anticipated">May 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">May 31, 2021</primary_completion_date>
  <phase>N/A</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>Up to 3 years</time_frame>
    <description>Defined as time from randomisation to first progression by investigator assessment using modified RECIST 1.1 or death (by any cause in the absence of progression)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Objective Response Rate (ORR)</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>Objective response rate is defined as the proportion of patients with measurable disease at baseline who have confirmed complete response (CR) or partial response (PR) as determined by the Investigator at local site</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>Defined as the time from randomisation to death due to any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants who Experience an Adverse Event (AE)</measure>
    <time_frame>Up to 1 years</time_frame>
    <description>An AE is defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy can be determined.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Endometrial Cancer</condition>
  <arm_group>
    <arm_group_label>Durvalumab and Lenvatinib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Combination therapy of Lenvatinib 80-120mg daily orally and durvalumab 1500mg by IV infusion every 4 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Durvalumab</intervention_name>
    <description>Anti-PD-L1 Monoclonal Antibody</description>
    <arm_group_label>Durvalumab and Lenvatinib</arm_group_label>
    <other_name>Durvalumab injection</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lenvatinib Oral Product</intervention_name>
    <description>Lenvatinib (Lenvima, Eisai China) is a novel angiogenesis inhibitor which targets vascular endothelial growth factor 1-3, fibroblast growth factor receptor 1-4, platelet-derived growth factor receptor β, RET and KIT</description>
    <arm_group_label>Durvalumab and Lenvatinib</arm_group_label>
    <other_name>LENVIMA</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥18 years at the time of screening and female.&#xD;
&#xD;
          -  Histologically confirmed diagnosis of epithelial endometrial carcinoma.&#xD;
&#xD;
          -  Patient must have endometrial cancer in one of the following categories:&#xD;
&#xD;
               -  Newly diagnosed Stage III disease (measurable disease per RECIST 1.1 following&#xD;
                  surgery or diagnostic biopsy),&#xD;
&#xD;
               -  Newly diagnosed Stage IV disease (with or without disease following surgery or&#xD;
                  diagnostic biopsy)&#xD;
&#xD;
               -  Recurrence of disease where the potential for cure by surgery alone or in&#xD;
                  combination is poor.&#xD;
&#xD;
          -  Not eligible for hormonal therapy (because of negative hormone receptor/poor&#xD;
             differentiation, or after failure of hormonal therapy).&#xD;
&#xD;
          -  Naïve to first line systemic anti-cancer treatment. For patients with recurrent&#xD;
             disease only, prior chemotherapy is allowed only if it was administered in the&#xD;
             adjuvant setting and there is at least 12 months from date of last dose of&#xD;
             chemotherapy administered to date of subsequent relapse&#xD;
&#xD;
          -  Adequate organ system function as measured within 28 days prior to administration of&#xD;
             study treatment, as defined below:&#xD;
&#xD;
        Haemoglobin ≥ 10.0 g/dL, with no blood transfusion in the past 28 days. Absolute neutrophil&#xD;
        count (ANC) ≥ 1.5 x 10^9/L Platelet count ≥ 100 x 10^9/L Total bilirubin ≤ 1.5 x&#xD;
        institutional upper limit of normal (ULN) (not applicable to Gilbert's syndrome) Aspartate&#xD;
        aminotransferase (AST) (Serum Glutamic Oxaloacetic Transaminase (SGOT)) / Alanine&#xD;
        aminotransferase (ALT) (Serum Glutamic Pyruvate Transaminase (SGPT)) ≤ 2.5 x ULN unless&#xD;
        liver metastases are present in which case they must be ≤ 5x ULN Patients must have&#xD;
        creatinine clearance estimated of ≥51 mL/min estimated using the Cockcroft-Gault equation&#xD;
        or 24 hr urine clearance.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any previous treatment with a PD1 or PD-L1 inhibitor&#xD;
&#xD;
          -  Has a history of (noninfectious) pneumonitis that required steroids or has current&#xD;
             pneumonitis&#xD;
&#xD;
          -  History of leptomeningeal carcinomatosis, symptomatic uncontrolled brain metastases&#xD;
             (≤2mg/ day corticosteroids started ≥4 weeks prior to treatment is accepted) and spinal&#xD;
             cord compression (unless received definitive treatment and clinically stable for 28&#xD;
             days) .&#xD;
&#xD;
          -  Has an active infection requiring systemic therapy.&#xD;
&#xD;
          -  Has a known history of human immunodeficiency virus (HIV) infection.&#xD;
&#xD;
          -  Has known active tuberculosis (TB; Bacillus tuberculosis).&#xD;
&#xD;
          -  Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with&#xD;
             an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4,&#xD;
             OX-40, CD137).&#xD;
&#xD;
          -  Has received a live vaccine within 30 days prior to the first dose of study treatment.&#xD;
&#xD;
          -  Is currently participating in or has participated in a study of an investigational&#xD;
             agent or has used an investigational device within 4 weeks prior to Cycle 1, Day 1.&#xD;
&#xD;
          -  Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy&#xD;
             or any other form of immunosuppressive therapy within 7 days prior to Cycle 1, Day 1.&#xD;
&#xD;
          -  Has severe hypersensitivity (≥Grade 3) to Durvalumab and/or any of its excipients.&#xD;
&#xD;
          -  Has an active autoimmune disease that has required systemic treatment in past 2 years.&#xD;
&#xD;
          -  Has a known psychiatric or substance abuse disorder that would interfere with the&#xD;
             participant's ability to cooperate with the requirements of the study.&#xD;
&#xD;
          -  Is pregnant or breastfeeding or expecting to conceive or father children within the&#xD;
             projected duration of the study, starting with the screening visit through 120 days&#xD;
             after the last dose of study treatment.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xiaoping Wan, MD.,Ph.D</last_name>
    <role>Study Chair</role>
    <affiliation>Shanghai First Maternity and Infant Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Huan Tong</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shanghai First Maternity and Infant Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Huan Tong</last_name>
    <phone>008615216653806</phone>
    <email>tonghuan@tongji.edu.cn</email>
  </overall_contact>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 20, 2020</study_first_submitted>
  <study_first_submitted_qc>June 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>June 20, 2020</last_update_submitted>
  <last_update_submitted_qc>June 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>endometrial cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Endometrial Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Durvalumab</mesh_term>
    <mesh_term>Lenvatinib</mesh_term>
    <mesh_term>Antibodies, Monoclonal</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/NCT04444193
org study id: SHFMIH-IIT-2020-0005
nct id: NCT04444193
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study will evaluate the safety and efficacy of durvalumab in combination with lenvatinib
      in participants with advanced and recurrent endometrial carcinoma.The primary hypothesis of
      this study are that patients with advanced and recurrent endometrial carcinoma could benefit
      from durvalumab plus lenvatinib with respect to: 1)Progression Free Survival (PFS) ; 2)
      Objective Response Rate (ORR); and Overall survival (OS). The investigators design a clinical
      study to explore whether the combination above as a treatment in patients with advanced and
      recurrent endometrial carcinoma could prolong PFS and to analyze potential immune biomarker
      of therapeutic response.
The combination of Lenvatinib and Programmed death-ligand 1 (PD-L1) blocking has great
      potential in the treatment of advanced and recurrent endometrial cancer. This trial is
      designed as a prospective, open label study for 20 patients with advanced (recurrent,
      refractory or metastatic) endometrial cancer, including carcinosarcoma of the uterus. The aim
      is to investigate the efficacy of the combination therapy of Lenvatinib 80-120mg daily orally
      and durvalumab 1500mg by IV infusion every 4 weeks in terms of progression free survival.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression Free Survival (PFS)
time frame: Up to 3 years
description: Defined as time from randomisation to first progression by investigator assessment using modified RECIST 1.1 or death (by any cause in the absence of progression)
measure: Objective Response Rate (ORR)
time frame: Up to 3 years
description: Objective response rate is defined as the proportion of patients with measurable disease at baseline who have confirmed complete response (CR) or partial response (PR) as determined by the Investigator at local site
measure: Overall Survival (OS)
time frame: Up to 5 years
description: Defined as the time from randomisation to death due to any cause
measure: Percentage of Participants who Experience an Adverse Event (AE)
time frame: Up to 1 years
description: An AE is defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy can be determined.
arm group label: Durvalumab and Lenvatinib
arm group type: Experimental
description: Combination therapy of Lenvatinib 80-120mg daily orally and durvalumab 1500mg by IV infusion every 4 weeks
intervention type: Drug
intervention name: Durvalumab
description: Anti-PD-L1 Monoclonal Antibody
arm group label: Durvalumab and Lenvatinib
other name: Durvalumab injection
intervention type: Drug
intervention name: Lenvatinib Oral Product
description: Lenvatinib (Lenvima, Eisai China) is a novel angiogenesis inhibitor which targets vascular endothelial growth factor 1-3, fibroblast growth factor receptor 1-4, platelet-derived growth factor receptor β, RET and KIT
arm group label: Durvalumab and Lenvatinib
other name: LENVIMA
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Xiaoping Wan, MD.,Ph.D
role: Study Chair
affiliation: Shanghai First Maternity and Infant Hospital
last name: Huan Tong
role: Principal Investigator
affiliation: Shanghai First Maternity and Infant Hospital
last name: Huan Tong
phone: 008615216653806
email: tonghuan@tongji.edu.cn
responsible party type: Sponsor
mesh term: Endometrial Neoplasms
mesh term: Durvalumab
mesh term: Lenvatinib
mesh term: Antibodies, Monoclonal