<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/NCT03753919</url>
  </required_header>
  <id_info>
    <org_study_id>GETNE-T1812</org_study_id>
    <secondary_id>2018-001066-42</secondary_id>
    <nct_id>NCT03753919</nct_id>
  </id_info>
  <brief_title>Durvalumab Plus Tremelimumab for the Treatment of Patients With Progressive, Refractory Advanced Thyroid Carcinoma -The DUTHY Trial</brief_title>
  <acronym>DUTHY</acronym>
  <official_title>A Phase II Study of Durvalumab (MEDI4736) Plus Tremelimumab for the Treatment of Patients With Progressive, Refractory Advanced Thyroid Carcinoma - The DUTHY Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Grupo Espanol de Tumores Neuroendocrinos</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>MFAR</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Grupo Espanol de Tumores Neuroendocrinos</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective, multi-centre, open label, stratified, exploratory phase II study&#xD;
      evaluating the efficacy and safety of durvalumab plus tremelimumab in different cohorts of&#xD;
      patients with thyroid cancers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 2, 2019</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">July 2023</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>
    <intervention_model_description>Cohort 1: Advanced, radioiodine-refractory differentiated thyroid carcinoma, including papillary, follicular, Hürtle. Cell and poorly-differentiated thyroid carcinoma (DTC).&#xD;
Cohort 2: Advanced medullary thyroid carcinoma (MTC).&#xD;
Cohort 3: Advanced anaplastic thyroid cancer (ATC).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Progression-free survival rate at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>Percentage of patients without progression of disease at month 6, according RECIST 1.1 criteria.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall survival rate at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>Percentage of patients alive at month 6 from first dose of treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall response rate (ORR)</measure>
    <time_frame>42 months</time_frame>
    <description>Response to treatment according to RECIST 1.1 criteria or iRECIST 1.1 criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of response (DoR)</measure>
    <time_frame>From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 42 months</time_frame>
    <description>Length of time between start of treatment and date of evidenced response and progression of disease according irRECIST or RECIST 1.1 criteria, or death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median progression-free survival</measure>
    <time_frame>42 months</time_frame>
    <description>Length of time between date of evidenced response and progression of disease according irRECIST or RECIST 1.1 criteria, or death, or death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]</measure>
    <time_frame>42 months</time_frame>
    <description>Number and type of adverse events reported throughout the study period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median Overall Survival</measure>
    <time_frame>42 months</time_frame>
    <description>Length of time between start of treatment and death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response status after start of study treatment</measure>
    <time_frame>6 and 12 months after start of the study treatment</time_frame>
    <description>According irRECIST/RECIST</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">46</enrollment>
  <condition>Metastatic Thyroid Papillary Carcinoma</condition>
  <condition>Metastatic Thyroid Follicular Carcinoma</condition>
  <condition>Metastatic Thyroid Cancer</condition>
  <arm_group>
    <arm_group_label>Durvalumab + Tremelimumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Durvalumab 1500 mg plus tremelimumab 75 mg every 4 weeks up to 4 cycles followed by durvalumab 1500 mg every 4 weeks until disease progression, unacceptable toxicity or patients' decision.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Durvalumab</intervention_name>
    <description>Subjects will be allocated in each primary tumor cohort to receive durvalumab 1500 mg every 4 weeks (Q4W) plus tremelimumab 75 mg Q4W for up to 4 doses during the first 4 cycles of combined therapy. After the first 4 cycles (or before is tremelimumab is stopped due to toxicity), patients will continue to receive durvalumab 1500 mg Q4W until disease progression or unacceptable toxicity. Cycles are defined by 4 weeks or 28 days.</description>
    <arm_group_label>Durvalumab + Tremelimumab</arm_group_label>
    <other_name>MEDI4736</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tremelimumab</intervention_name>
    <description>Subjects will be allocated in each primary tumor cohort to receive durvalumab 1500 mg every 4 weeks (Q4W) plus tremelimumab 75 mg Q4W for up to 4 doses during the first 4 cycles of combined therapy. After the first 4 cycles (or before is tremelimumab is stopped due to toxicity), patients will continue to receive durvalumab 1500 mg Q4W until disease progression or unacceptable toxicity. Cycles are defined by 4 weeks or 28 days.</description>
    <arm_group_label>Durvalumab + Tremelimumab</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Written informed consent obtained from the subject prior to performing any&#xD;
             protocol-related procedures, including screening evaluations.&#xD;
&#xD;
          -  Age ≥ 18 years at time of study entry.&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.&#xD;
&#xD;
          -  Body weight &gt;30kg.&#xD;
&#xD;
          -  Confirmed differentiated thyroid cancer (papillary, follicular, poorly differentiated&#xD;
             and Hürtle cell), medullary thyroid cancer and anaplastic thyroid cancer.&#xD;
&#xD;
          -  Available tumor and blood samples for translational research&#xD;
&#xD;
          -  Patients should meet one of the following criteria:&#xD;
&#xD;
               1. Cohort 1: Patients with locally advanced or metastatic differentiated thyroid&#xD;
                  cancer (including the subtypes of papillary, follicular, poorly differentiated&#xD;
                  and Hürthle cell carcinoma) after disease progression on systemic therapy with&#xD;
                  MKIs. Patients could be recruited in the study after progression on Lenvatinib&#xD;
                  (regardless prior lines) or progression on at least two prior MKIs which may or&#xD;
                  not include Lenvatinib. No prior therapy with immune check point inhibitors is&#xD;
                  allowed. Patients with intolerable toxicity to MKIs that meet the prior inclusion&#xD;
                  criteria and experience disease progression by RECIST v1.1 after stopping therapy&#xD;
                  may be included.&#xD;
&#xD;
               2. Cohort 2: Patients with locally advanced or metastatic medullary thyroid cancer&#xD;
                  after progression on systemic therapy with MKIs. Patients could be recruited in&#xD;
                  the study after progression to Vandetanib (regardless prior lines) or progression&#xD;
                  to at least two prior MKIs that may or not include Vandetanib. No prior therapy&#xD;
                  with immune check point inhibitors is allowed. Patients with intolerable toxicity&#xD;
                  to MKIs that meet the prior inclusion criteria and experience disease progression&#xD;
                  by RECIST v1.1 after stopping therapy may be included.&#xD;
&#xD;
               3. Cohort 3: Patients with locally advanced or metastatic anaplastic thyroid cancer&#xD;
                  regardless of prior therapy. No prior therapy with immune check point inhibitors&#xD;
                  is allowed.&#xD;
&#xD;
          -  No limitation of number of prior therapies.&#xD;
&#xD;
          -  Life expectancy &gt;3 months&#xD;
&#xD;
          -  Adequate normal organ and marrow function as defined below: a) Haemoglobin ≥9.0 g/dL.&#xD;
             b) Absolute neutrophil count (ANC) &gt; 1500 per mm3. c) Platelet count ≥100,000 per mm3.&#xD;
             d) Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN). This will not&#xD;
             apply to patients with confirmed Gilbert's syndrome (persistent or recurrent&#xD;
             hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or&#xD;
             hepatic pathology), who will be allowed only in consultation with their physician. e)&#xD;
             AST (SGOT)/ALT (SGPT) ≤2.5 x institutional upper limit of normal. f) Measured&#xD;
             creatinine clearance (CL) &gt;40 mL/min or Calculated creatinine CL&gt;40mL/min by the&#xD;
             Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for&#xD;
             determination of creatinine clearance.&#xD;
&#xD;
          -  Evidence of post-menopausal status or negative urinary or serum pregnancy test for&#xD;
             female pre- menopausal patients. Women will be considered post-menopausal if they have&#xD;
             been amenorrheic for 12 months without an alternative medical cause. The following&#xD;
             age-specific requirements apply: a) Women &lt;50 years of age would be considered&#xD;
             post-menopausal if they have been amenorrheic for 12 months or more following&#xD;
             cessation of exogenous hormonal treatments and if they have luteinizing hormone and&#xD;
             follicle-stimulating hormone levels in the post-menopausal range for the institution&#xD;
             or underwent surgical sterilization (bilateral oophorectomy or hysterectomy). b) Women&#xD;
             ≥50 years of age would be considered post-menopausal if they have been amenorrheic for&#xD;
             12 months or more following cessation of all exogenous hormonal treatments, had&#xD;
             radiation-induced menopause with last menses &gt;1 year ago, had chemotherapy-induced&#xD;
             menopause with last menses &gt;1 year ago, or underwent surgical sterilization (bilateral&#xD;
             oophorectomy, bilateral salpingectomy or hysterectomy).&#xD;
&#xD;
          -  Patient is willing and able to comply with the protocol for the duration of the study&#xD;
             including undergoing treatment and scheduled visits and examinations including follow&#xD;
             up.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participation in another clinical study with an investigational product during the&#xD;
             last 21 days.&#xD;
&#xD;
          -  Concurrent enrolment in another clinical study, unless it is an observational&#xD;
             (non-interventional) clinical study or during the follow-up period of an&#xD;
             interventional study.&#xD;
&#xD;
          -  Any previous treatment with a PD1, PD-L1 or CTLA-4 inhibitor, including durvalumab and&#xD;
             tremelimumab.&#xD;
&#xD;
          -  Any previous treatment with immunotherapy, including combinations of immunotherapy and&#xD;
             other anticancer or targeted agents.&#xD;
&#xD;
          -  Mean QT interval corrected for heart rate (QTc) ≥470 ms calculated from 3&#xD;
             electrocardiograms (ECGs) using Fridericia's Correction.&#xD;
&#xD;
          -  Current or prior use of immunosuppressive medication within 28 days before the first&#xD;
             dose of durvalumab, with the exceptions of intranasal and inhaled corticosteroids or&#xD;
             systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of&#xD;
             prednisone, or an equivalent corticosteroid. The following are exceptions to this&#xD;
             criterion: a) Intranasal, inhaled, topical steroids, or local steroid injections&#xD;
             (e.g., intra articular injection). b) Systemic corticosteroids at physiologic doses&#xD;
             not to exceed 10 mg/day of prednisone or its equivalent. c) Steroids as premedication&#xD;
             for hypersensitivity reactions (e.g., CT scan premedication).&#xD;
&#xD;
          -  Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the&#xD;
             exception of alopecia, vitiligo, and the laboratory values defined in the inclusion&#xD;
             criteria: a) Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case&#xD;
             basis after consultation with the Study Physician. b) Patients with irreversible&#xD;
             toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be&#xD;
             included only after consultation with the Study Physician.&#xD;
&#xD;
          -  Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment.&#xD;
             Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone&#xD;
             replacement therapy) is acceptable.&#xD;
&#xD;
          -  History of allogenic organ transplantation.&#xD;
&#xD;
          -  Active or prior documented autoimmune or inflammatory disorders (including&#xD;
             inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with&#xD;
             the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome,&#xD;
             or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid&#xD;
             arthritis, hypophysitis, uveitis, etc.]). The following are exceptions to this&#xD;
             criterion: a) Patients with vitiligo or alopecia. b) Patients with hypothyroidism&#xD;
             (e.g., following Hashimoto syndrome) stable on hormone replacement. c) Any chronic&#xD;
             skin condition that does not require systemic therapy. d) Patients without active&#xD;
             disease in the last 5 years may be included but only after consultation with the study&#xD;
             physician. e) Patients with celiac disease controlled by diet alone.&#xD;
&#xD;
          -  Uncontrolled intercurrent illness, including but not limited to, ongoing or active&#xD;
             infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable&#xD;
             angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic&#xD;
             gastrointestinal conditions associated with diarrhea, or psychiatric illness/social&#xD;
             situations that would limit compliance with study requirement, substantially increase&#xD;
             risk of incurring AEs or compromise the ability of the patient to give written&#xD;
             informed consent.&#xD;
&#xD;
          -  History of another primary malignancy except for: a) Malignancy treated with curative&#xD;
             intent and with no known active disease ≥5 years before the first dose of IP and of&#xD;
             low potential risk for recurrence. b) Adequately treated non-melanoma skin cancer or&#xD;
             lentigomaligna without evidence of disease. c) Adequately treated carcinoma in situ&#xD;
             without evidence of disease.&#xD;
&#xD;
          -  History of active primary immunodeficiency.&#xD;
&#xD;
          -  Active infection including tuberculosis (clinical evaluation that includes clinical&#xD;
             history, physical examination and radiographic findings, and TB testing in line with&#xD;
             local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result),&#xD;
             hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies). Patients&#xD;
             with a past or resolved HBV infection (defined as the presence of hepatitis B core&#xD;
             antibody [anti-HBc] and absence of HBsAg) are eligible. Patients positive for&#xD;
             hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative&#xD;
             for HCV RNA.&#xD;
&#xD;
          -  Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note:&#xD;
             Patients, if enrolled, should not receive live vaccine whilst receiving IP and up to&#xD;
             30 days after the last dose of IP.&#xD;
&#xD;
          -  Female patients who are pregnant or breastfeeding or male or female patients of&#xD;
             reproductive potential who are not willing to employ highly effective birth control&#xD;
             from screening to 90 days after the last dose of durvalumab monotherapy and 180 days&#xD;
             for combined treatment with durvalumab and tremelimumab.&#xD;
&#xD;
          -  Known allergy or hypersensitivity to any of the study drugs or any of the study drug&#xD;
             excipients.&#xD;
&#xD;
          -  Judgment by the investigator that the patient is unsuitable to participate in the&#xD;
             study and the patient is unlikely to comply with study procedures, restrictions and&#xD;
             requirements.&#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>Jaume Capdevila, M.D., Ph.D.</last_name>
    <role>Study Chair</role>
    <affiliation>Hospital Universitari Vall d'Hebron, Barcelona</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>A responsible person designated by the sponsor</last_name>
    <phone>+34 93 434 44 12</phone>
    <email>investigacion@mfar.net</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Responsible person designated by the sponsor</last_name>
    <phone>+34 93 434 44 12</phone>
    <email>investigacion@mfar.net</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Instituto Catalán de Oncología de Hospitalet</name>
      <address>
        <city>L'Hospitalet de Llobregat</city>
        <state>Barcelona</state>
        <zip>08908</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>A responsible person designated by the sponsor</last_name>
      <email>investigacion@mfar.net</email>
    </contact>
    <investigator>
      <last_name>Principal investigator selected by the sponsor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital Provincial de Castellón</name>
      <address>
        <city>Castelló</city>
        <state>Valencia</state>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>A responsible person designated by the sponsor</last_name>
      <email>investigacion@mfar.net</email>
    </contact>
    <investigator>
      <last_name>Principal investigator selected by the sponsor, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital Clínic Barcelona</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>A responsible person designated by the sponsor</last_name>
      <email>investigacion@mfar.net</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Vall d'Hebron</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>A responsible person designated by the sponsor</last_name>
      <email>investigacion@mfar.net</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>MD Anderson Cancer Center</name>
      <address>
        <city>Madrid</city>
        <zip>28033</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>A responsible person designated by the sponsor</last_name>
      <email>investigacion@mfar.net</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Clínico San Carlos</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>A responsible person designated by the sponsor</last_name>
      <email>investigacion@mfar.net</email>
    </contact>
    <investigator>
      <last_name>Principal investigator selected by the sponsor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario 12 de Octubre</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>A responsible person designated by the sponsor</last_name>
    </contact>
    <contact_backup>
      <email>investigacion@mfar.net</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario HM Sanchinarro</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>A responsible person designated by the sponsor</last_name>
      <email>investigacion@mfar.net</email>
    </contact>
    <investigator>
      <last_name>Principal investigator selected by the sponsor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario La Paz</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>A responsible person designated by the sponsor</last_name>
      <email>investigacion@mfar.net</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Ramón y Cajal</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>A responsible person designated by the sponsor</last_name>
      <email>investigacion@mfar.net</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario Morales Meseguer</name>
      <address>
        <city>Murcia</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>A responsible person designated by the sponsor</last_name>
      <email>investigacion@mfar.net</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen de la Victoria</name>
      <address>
        <city>Málaga</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>A responsible person designated by the sponsor</last_name>
      <email>investigacion@mfar.net</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Clínica Universidad de Navarra</name>
      <address>
        <city>Pamplona</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>A responsible person designated by the sponsor</last_name>
      <email>investigacion@mfar.net</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Instituto Valenciano de Oncología</name>
      <address>
        <city>Valencia</city>
        <zip>46009</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>A responsible person designated by the sponsor</last_name>
      <email>investigacion@mfar.net</email>
    </contact>
    <investigator>
      <last_name>Principal investigator selected by the sponsor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario Universitario de Vigo (CHUVI)</name>
      <address>
        <city>Vigo</city>
        <zip>36036</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>A responsible person designated by the sponsor</last_name>
      <email>investigacion@mfar.net</email>
    </contact>
    <investigator>
      <last_name>Principal investigator selected by the sponsor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>November 20, 2018</study_first_submitted>
  <study_first_submitted_qc>November 22, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>October 24, 2022</last_update_submitted>
  <last_update_submitted_qc>October 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 25, 2022</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>Carcinoma</mesh_term>
    <mesh_term>Thyroid Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Papillary</mesh_term>
    <mesh_term>Adenocarcinoma, Follicular</mesh_term>
    <mesh_term>Thyroid Cancer, Papillary</mesh_term>
    <mesh_term>Thyroid Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Durvalumab</mesh_term>
    <mesh_term>Tremelimumab</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/NCT03753919
org study id: GETNE-T1812
secondary id: 2018-001066-42
nct id: NCT03753919
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a prospective, multi-centre, open label, stratified, exploratory phase II study
      evaluating the efficacy and safety of durvalumab plus tremelimumab in different cohorts of
      patients with thyroid cancers.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Cohort 1: Advanced, radioiodine-refractory differentiated thyroid carcinoma, including papillary, follicular, Hürtle. Cell and poorly-differentiated thyroid carcinoma (DTC).
Cohort 2: Advanced medullary thyroid carcinoma (MTC).
Cohort 3: Advanced anaplastic thyroid cancer (ATC).
primary purpose: Treatment
masking: None (Open Label)
measure: Progression-free survival rate at 6 months
time frame: 6 months
description: Percentage of patients without progression of disease at month 6, according RECIST 1.1 criteria.
measure: Overall survival rate at 6 months
time frame: 6 months
description: Percentage of patients alive at month 6 from first dose of treatment.
measure: Overall response rate (ORR)
time frame: 42 months
description: Response to treatment according to RECIST 1.1 criteria or iRECIST 1.1 criteria
measure: Duration of response (DoR)
time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 42 months
description: Length of time between start of treatment and date of evidenced response and progression of disease according irRECIST or RECIST 1.1 criteria, or death
measure: Median progression-free survival
time frame: 42 months
description: Length of time between date of evidenced response and progression of disease according irRECIST or RECIST 1.1 criteria, or death, or death
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
time frame: 42 months
description: Number and type of adverse events reported throughout the study period
measure: Median Overall Survival
time frame: 42 months
description: Length of time between start of treatment and death
measure: Response status after start of study treatment
time frame: 6 and 12 months after start of the study treatment
description: According irRECIST/RECIST
arm group label: Durvalumab + Tremelimumab
arm group type: Experimental
description: Durvalumab 1500 mg plus tremelimumab 75 mg every 4 weeks up to 4 cycles followed by durvalumab 1500 mg every 4 weeks until disease progression, unacceptable toxicity or patients' decision.
intervention type: Drug
intervention name: Durvalumab
description: Subjects will be allocated in each primary tumor cohort to receive durvalumab 1500 mg every 4 weeks (Q4W) plus tremelimumab 75 mg Q4W for up to 4 doses during the first 4 cycles of combined therapy. After the first 4 cycles (or before is tremelimumab is stopped due to toxicity), patients will continue to receive durvalumab 1500 mg Q4W until disease progression or unacceptable toxicity. Cycles are defined by 4 weeks or 28 days.
arm group label: Durvalumab + Tremelimumab
other name: MEDI4736
intervention type: Drug
intervention name: Tremelimumab
description: Subjects will be allocated in each primary tumor cohort to receive durvalumab 1500 mg every 4 weeks (Q4W) plus tremelimumab 75 mg Q4W for up to 4 doses during the first 4 cycles of combined therapy. After the first 4 cycles (or before is tremelimumab is stopped due to toxicity), patients will continue to receive durvalumab 1500 mg Q4W until disease progression or unacceptable toxicity. Cycles are defined by 4 weeks or 28 days.
arm group label: Durvalumab + Tremelimumab
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jaume Capdevila, M.D., Ph.D.
role: Study Chair
affiliation: Hospital Universitari Vall d'Hebron, Barcelona
last name: A responsible person designated by the sponsor
phone: +34 93 434 44 12
email: investigacion@mfar.net
last name: Responsible person designated by the sponsor
phone: +34 93 434 44 12
email: investigacion@mfar.net
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
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status: Recruiting
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status: Recruiting
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facility: 
status: Recruiting
contact: 
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facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: Spain
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Thyroid Neoplasms
mesh term: Carcinoma, Papillary
mesh term: Adenocarcinoma, Follicular
mesh term: Thyroid Cancer, Papillary
mesh term: Thyroid Diseases
mesh term: Durvalumab
mesh term: Tremelimumab
sharing ipd: Undecided