<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/NCT03267589</url>
  </required_header>
  <id_info>
    <org_study_id>ENGOT-OV30 / NSGO</org_study_id>
    <nct_id>NCT03267589</nct_id>
  </id_info>
  <brief_title>Trial in Patients With Relapsed Ovarian Cancer</brief_title>
  <official_title>NSGO-OV-UMB1; ENGOT-OV30 / NSGO: A Phase II Umbrella Trial in Patients With Relapsed Ovarian Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nordic Society of Gynaecological Oncology - Clinical Trials Unit</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Gynecologic Cancer Intergroup (GCIG)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>European Network of Gynaecological Oncological Trial Groups (ENGOT)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Nordic Society of Gynaecological Oncology - Clinical Trials Unit</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overall objectiv is to obtain preliminary evidence of efficacy of novel agents for the&#xD;
      management of relapsed ovarian cancer, and in part 2 efficacy of novel agents compared to the&#xD;
      standard of care (SoC).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 14, 2018</start_date>
  <completion_date type="Actual">October 19, 2021</completion_date>
  <primary_completion_date type="Actual">October 19, 2021</primary_completion_date>
  <phase>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>
    <intervention_model_description>Part 1: single cohorts of novel agents Part 2: randomized phase 2 against standard of care.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Disease control rate (DCR)</measure>
    <time_frame>16 weeks</time_frame>
    <description>Disease control rate (DCR) (CR+PR+SD)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression-Free Survival (PFS) by RECIST v1.1</measure>
    <time_frame>10 months</time_frame>
    <description>PFS by RECIST v1.1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PFS by Immune-RECIST</measure>
    <time_frame>10 months</time_frame>
    <description>PFS by Immune-RECIST</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>36 months</time_frame>
    <description>Overall survival (OS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective response rate</measure>
    <time_frame>10 months</time_frame>
    <description>Objective response rate according to RECIST v1.1 (ORR)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of (Overall) Response (DoR)</measure>
    <time_frame>10 months</time_frame>
    <description>Duration of (Overall) Response (DoR)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Ovarian Cancer</condition>
  <arm_group>
    <arm_group_label>Cohort A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: MEDI9447 (CD73) + durvalumab</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: MEDI0562 (OX40) + durvalumab</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: MEDI0562 (OX40) + tremelimumab combination</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Durvalumab, Tremelilumab, MEDI 9447, MEDI 0562</intervention_name>
    <description>Three different combination are being tested. Each cohort has different combination</description>
    <arm_group_label>Cohort A</arm_group_label>
    <arm_group_label>Cohort B</arm_group_label>
    <arm_group_label>Cohort C</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Platinum-sensitive disease: defined as disease progression ≥ 6 months following the&#xD;
             last administered dose of platinum-based therapy. Patients must have received atleast&#xD;
             one line of chemotherapy for platinum-sensitive disease. OR&#xD;
&#xD;
          2. Platinum-resistant disease: defined as disease progression &lt; 6 months following the&#xD;
             last administered dose of platinum-based therapy.&#xD;
&#xD;
             OR&#xD;
&#xD;
          3. Platinum-refractory disease: defined as lack of response or disease progression while&#xD;
             receiving the most recent therapy.&#xD;
&#xD;
             Other key inclusion criteria:&#xD;
&#xD;
          4. Histological confirmed ovarian, fallopian tube or peritoneal cancers.&#xD;
&#xD;
          5. Histological types: high-grade serious, high-grade endometriod, undifferentiated,&#xD;
             carcinosarcoma or mixed histology.&#xD;
&#xD;
          6. Subjects must have at least 1 measurable lesion as defined by RECIST guidelines. This&#xD;
             should not be the same lesion used for biopsy.&#xD;
&#xD;
          7. Patients entering cohort A: Archival tumour tissue must be screened for CD73 and only&#xD;
             CD73 positive patients (defined as &gt;10% of tumor cells positive) will enter this&#xD;
             trial.&#xD;
&#xD;
          8. Patient agrees to undergo all analysis (blood, serum, tissue); radiological&#xD;
             examinations according to protocol.&#xD;
&#xD;
          9. Mandatory tumour biopsy before treatment (before day 0) and at day 56 of treatment.&#xD;
&#xD;
         10. Patients must give informed consent.&#xD;
&#xD;
         11. Patients must be at least 18 years of age.&#xD;
&#xD;
         12. ECOG performance status 0-1&#xD;
&#xD;
         13. Serum albumin &gt;30g/l.&#xD;
&#xD;
         14. Adequate organ function&#xD;
&#xD;
         15. Life expectancy of at least 12 weeks.&#xD;
&#xD;
         16. Patients must be fit to receive Investigational medical products (IMPs)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects using immunosuppressive medications within 14 days.&#xD;
&#xD;
          2. Immunodeficiency or organ transplant&#xD;
&#xD;
          3. Live vaccines within 28 days prior to the first dose.&#xD;
&#xD;
          4. Major surgery within 28 days prior to the first dose.&#xD;
&#xD;
          5. Ovarian sarcomas, small cell carcinoma with neuroendocrine differentiation,&#xD;
             non-epithelial can-cers.&#xD;
&#xD;
          6. Cancer therapies (chemotherapy, radiotherapy, surgery, immunotherapy, biologic or&#xD;
             hormonal therapy) within 28 days prior to the first dose.&#xD;
&#xD;
          7. Concurrent treatment with an investigational agent or participation in another&#xD;
             clinical trial.&#xD;
&#xD;
          8. Previous malignant disease: patients are not eligible for the study if actively being&#xD;
             treated of inva-sive cancer other than ovarian cancer. Patients with previous&#xD;
             malignant disease other than ovarian cancer who are relapse-free and treatment-free&#xD;
             for more than three years may enter this study. Pa-tients with previous history of&#xD;
             in-situ carcinoma, stage 1A cervical cancer or non-invasive basal cell and squamous&#xD;
             cell skin carcinoma can enter this trial.&#xD;
&#xD;
          9. Active infection including tuberculosis&#xD;
&#xD;
         10. History of a cerebral vascular accident, transient ischemic attack or subarachnoid&#xD;
             hemorrhage within the past 6 months.&#xD;
&#xD;
         11. History of clinically significant hemorrhage in the past 3 months.&#xD;
&#xD;
         12. Untreated CNS disease, leptomeningeal disease or cord compression. Subjects with&#xD;
             treated dis-ease should have at least 4 weeks of neurologic and radiographic stability&#xD;
             and be off steroids for 14 days.&#xD;
&#xD;
         13. Significant cardiovascular disease's.&#xD;
&#xD;
         14. Persistance of clinically relevant therapy related toxicity from previous anticancer&#xD;
             therapy (any grade 3-4 toxicity or grade ≥2 neuropathy).&#xD;
&#xD;
         15. Known hypersensitivity to the trial drugs, or to their excipients.&#xD;
&#xD;
         16. Has had prior exposure to IMPs, or any other immunotherapy.&#xD;
&#xD;
         17. Active or prior documented autoimmune or inflammatory disorders&#xD;
&#xD;
         18. For cohorts B and C: Medical condition requiring current systemic anticoagulation, or&#xD;
             a history of congenital hypercoagulable condition. Subjects taking aspirin at doses &lt;&#xD;
             325 mg per day are eli-gible provided that prothrombin time is within the&#xD;
             institutional range of normal. Use of local anti-coagulation for port maintenance is&#xD;
             permitted&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mansoor R Mirza, MD</last_name>
    <role>Study Director</role>
    <affiliation>NSGO-CTU</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>VejleSygehus</name>
      <address>
        <city>Vejle</city>
        <state>Region Syddanmark</state>
        <zip>7100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rigshospitalet</name>
      <address>
        <city>København Ø</city>
        <state>Sjaelland</state>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tampere University Hospital</name>
      <address>
        <city>Tampere</city>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Haukeland University Hospital</name>
      <address>
        <city>Bergen</city>
        <state>Haukeland</state>
        <zip>5021</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Norwegian Radium Hospital</name>
      <address>
        <city>Oslo</city>
        <zip>0310</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
    <country>Finland</country>
    <country>Norway</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>July 5, 2017</study_first_submitted>
  <study_first_submitted_qc>August 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <last_update_submitted>September 7, 2023</last_update_submitted>
  <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>immunotherapy</keyword>
  <keyword>ovarian cancer</keyword>
  <keyword>durvalumab</keyword>
  <keyword>tremelilumab</keyword>
  <keyword>MEDI 9447</keyword>
  <keyword>MEDI 0562</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ovarian Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Ovarian Epithelial</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Durvalumab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Upon request.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>From December 2023.</ipd_time_frame>
  </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/NCT03267589
org study id: ENGOT-OV30 / NSGO
nct id: NCT03267589
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
The overall objectiv is to obtain preliminary evidence of efficacy of novel agents for the
      management of relapsed ovarian cancer, and in part 2 efficacy of novel agents compared to the
      standard of care (SoC).
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Part 1: single cohorts of novel agents Part 2: randomized phase 2 against standard of care.
primary purpose: Treatment
masking: None (Open Label)
measure: Disease control rate (DCR)
time frame: 16 weeks
description: Disease control rate (DCR) (CR+PR+SD)
measure: Progression-Free Survival (PFS) by RECIST v1.1
time frame: 10 months
description: PFS by RECIST v1.1
measure: PFS by Immune-RECIST
time frame: 10 months
description: PFS by Immune-RECIST
measure: Overall survival (OS)
time frame: 36 months
description: Overall survival (OS)
measure: Objective response rate
time frame: 10 months
description: Objective response rate according to RECIST v1.1 (ORR)
measure: Duration of (Overall) Response (DoR)
time frame: 10 months
description: Duration of (Overall) Response (DoR)
arm group label: Cohort A
arm group type: Experimental
description: Intervention: MEDI9447 (CD73) + durvalumab
arm group label: Cohort B
arm group type: Experimental
description: Intervention: MEDI0562 (OX40) + durvalumab
arm group label: Cohort C
arm group type: Experimental
description: Intervention: MEDI0562 (OX40) + tremelimumab combination
intervention type: Drug
intervention name: Durvalumab, Tremelilumab, MEDI 9447, MEDI 0562
description: Three different combination are being tested. Each cohort has different combination
arm group label: Cohort A
arm group label: Cohort B
arm group label: Cohort C
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mansoor R Mirza, MD
role: Study Director
affiliation: NSGO-CTU
facility: 
facility: 
facility: 
facility: 
facility: 
country: Denmark
country: Finland
country: Norway
responsible party type: Sponsor
mesh term: Ovarian Neoplasms
mesh term: Carcinoma, Ovarian Epithelial
mesh term: Durvalumab
sharing ipd: Yes
ipd description: Upon request.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: From December 2023.