<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/NCT04465487</url>
  </required_header>
  <id_info>
    <org_study_id>R6569-ONC-1933</org_study_id>
    <secondary_id>2020-000075-20</secondary_id>
    <nct_id>NCT04465487</nct_id>
  </id_info>
  <brief_title>Study of REGN6569 and Cemiplimab in Adult Patients With Advanced Solid Tumor Malignancies</brief_title>
  <official_title>A Phase 1 Study of REGN6569, an Anti-GITR mAb, With Cemiplimab in Patients With Advanced Solid Tumor Malignancies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Regeneron Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Regeneron Pharmaceuticals</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      For dose escalation cohorts, the primary objective is to evaluate the safety and tolerability&#xD;
      of REGN6569 as monotherapy lead-in and in combination with cemiplimab.&#xD;
&#xD;
      For dose expansion cohorts, the co-primary objectives are:&#xD;
&#xD;
        -  To assess the preliminary efficacy of REGN6569 in combination with cemiplimab, as&#xD;
           measured by objective response rate (ORR)&#xD;
&#xD;
        -  To assess the preliminary pharmacodynamic activity of REGN6569 as lead-in monotherapy,&#xD;
           as measured by intratumoral Glucocorticoid-Induced Tumor necrosis factor&#xD;
           receptor-Related (GITR)+ Treg depletion&#xD;
&#xD;
      Secondary Objectives are:&#xD;
&#xD;
      For dose escalation cohorts:&#xD;
&#xD;
        -  To assess preliminary efficacy of REGN6569 in combination with cemiplimab, as measured&#xD;
           by ORR, disease control rate (DCR), duration of response (DOR), progression-free&#xD;
           survival (PFS), and overall survival (OS)&#xD;
&#xD;
        -  To characterize the pharmacokinetics (PK) of REGN6569 alone and in combination with&#xD;
           cemiplimab&#xD;
&#xD;
        -  To assess the immunogenicity of REGN6569 and cemiplimab&#xD;
&#xD;
      For expansion cohorts:&#xD;
&#xD;
        -  To characterize the safety profile in each expansion cohort&#xD;
&#xD;
        -  To assess preliminary efficacy of REGN6569 in combination with cemiplimab, as measured&#xD;
           by DCR, DOR, PFS, and OS&#xD;
&#xD;
        -  To characterize the PK of REGN6569 alone and in combination with cemiplimab&#xD;
&#xD;
        -  To assess the immunogenicity of REGN6569 and cemiplimab&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 5, 2020</start_date>
  <completion_date type="Anticipated">July 8, 2026</completion_date>
  <primary_completion_date type="Anticipated">July 8, 2026</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of dose-limited toxicities (DLTs)</measure>
    <time_frame>Up to 42 days</time_frame>
    <description>Dose escalation period</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence and severity of treatment emergent adverse events(TEAEs)</measure>
    <time_frame>Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months</time_frame>
    <description>Dose escalation period</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence and severity of adverse events of special interest (AESIs)</measure>
    <time_frame>Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months</time_frame>
    <description>Dose escalation period</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence and severity of serious adverse events (SAEs)</measure>
    <time_frame>Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months</time_frame>
    <description>Dose escalation period</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence and severity of grade ≥3 laboratory abnormalities</measure>
    <time_frame>Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months</time_frame>
    <description>Dose escalation period</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Objective response rate (ORR)</measure>
    <time_frame>Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months</time_frame>
    <description>Dose expansion period</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage change in glucocorticoid-induced tumor necrosis factor receptor-Related(GITR)+ Treg density</measure>
    <time_frame>Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months</time_frame>
    <description>Dose expansion period</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ORR</measure>
    <time_frame>Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months</time_frame>
    <description>Dose escalation period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease control rate (DCR)</measure>
    <time_frame>Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months</time_frame>
    <description>Dose escalation and expansion periods</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response (DOR)</measure>
    <time_frame>Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months</time_frame>
    <description>Dose escalation and expansion periods</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free Survival (PFS)</measure>
    <time_frame>Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months</time_frame>
    <description>Dose escalation and expansion periods</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months</time_frame>
    <description>Dose escalation and expansion periods</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Drug concentrations of REGN6569 in serum</measure>
    <time_frame>Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months</time_frame>
    <description>Dose escalation and expansion periods</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Drug concentrations of cemiplimab in serum</measure>
    <time_frame>Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months</time_frame>
    <description>Dose escalation and expansion periods</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunogenicity as measured by anti-drug antibodies (ADA) to REGN6569</measure>
    <time_frame>Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months</time_frame>
    <description>Dose escalation and expansion periods</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunogenicity as measured by anti-drug antibodies (ADA) to cemiplimab</measure>
    <time_frame>Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months</time_frame>
    <description>Dose escalation and expansion periods</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">85</enrollment>
  <condition>Squamous Cell Carcinoma of Head and Neck</condition>
  <arm_group>
    <arm_group_label>REGN6569+cemiplimab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>REGN6569 lead-in</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>REGN6569</intervention_name>
    <description>Administered by intravenous (IV) infusion</description>
    <arm_group_label>REGN6569+cemiplimab</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cemiplimab</intervention_name>
    <description>Administered by IV infusion</description>
    <arm_group_label>REGN6569+cemiplimab</arm_group_label>
    <other_name>REGN2810</other_name>
    <other_name>Libtayo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          1. Dose escalation cohorts: Advanced stage (unresectable or metastatic) solid tumor&#xD;
             malignancy, confirmed histologically or cytologically as defined in the protocol&#xD;
&#xD;
          2. Dose expansion cohorts: Advanced stage (unresectable or metastatic) head and neck&#xD;
             squamous cell carcinoma(HNSCC), confirmed histologically or cytologically as defined&#xD;
             in the protocol&#xD;
&#xD;
          3. Mandatory biopsies: Able and willing to provide tumor tissue at baseline and while on&#xD;
             treatment, with at least 1 soft tissue lesion amenable to biopsy by ultrasound or&#xD;
             computed tomography (CT)-guided biopsy or under direct visualization&#xD;
&#xD;
             All Cohorts:&#xD;
&#xD;
          4. Has no prior history of immune checkpoint blockade (ICB) therapy&#xD;
&#xD;
          5. Has exhausted all approved available treatment options for their disease, with no&#xD;
             other standard therapy likely to convey clinical benefit as defined in the protocol&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          1. Has previously received GITR-targeted therapy&#xD;
&#xD;
          2. Has received any previous systemic biologic therapy within 5 half-lives of first dose&#xD;
             of study therapy as defined in the protocol&#xD;
&#xD;
          3. Has any condition that requires ongoing/continuous corticosteroid therapy (&gt;10 mg&#xD;
             prednisone/day or anti-inflammatory equivalent) within 14 days prior to the first dose&#xD;
             of study therapy&#xD;
&#xD;
          4. Has ongoing or recent (within 5 years) evidence of significant autoimmune disease that&#xD;
             required treatment with systemic immunosuppressive treatments as defined in the&#xD;
             protocol&#xD;
&#xD;
          5. Has a known history of, or any evidence of, interstitial lung disease, or active,&#xD;
             non-infectious pneumonitis in the past 5 years. A history of radiation pneumonitis in&#xD;
             the radiation field is permitted as long as pneumonitis resolved ≥6 months prior to&#xD;
             first dose of study therapy&#xD;
&#xD;
          6. Has uncontrolled infection with human immunodeficiency virus, hepatitis B or hepatitis&#xD;
             C infection, or diagnosis of immunodeficiency&#xD;
&#xD;
          7. Has received a live vaccine within 4 weeks of planned start of study medication. For&#xD;
             dose escalation only: Has received a COVID-19 vaccination within 1 week of planned&#xD;
             start of study medication or for which the planned COVID-19 vaccinations would not be&#xD;
             completed 1 week prior to start of study.&#xD;
&#xD;
          8. Has had prior allogeneic stem cell transplantation or received organ transplants at&#xD;
             any time, or autologous stem cell transplantation&#xD;
&#xD;
        Note: Other protocol-defined Inclusion/ Exclusion criteria 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>Clinical Trial Management</last_name>
    <role>Study Director</role>
    <affiliation>Regeneron Pharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Angeles Clinic and Research Institute - Clinic/Outpatient Facility</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90025</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>H.Lee Moffitt Cancer Center and Research Institute</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>START South Texas Accelerated Research Therapeutics</name>
      <address>
        <city>Grand Rapids</city>
        <state>Michigan</state>
        <zip>49503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Vall d'Hebrón</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ICO l'Hospitalet - Hospital Duran i Reynals</name>
      <address>
        <city>Barcelona</city>
        <zip>08908</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MD Anderson Cancer Center</name>
      <address>
        <city>Madrid</city>
        <zip>28033</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Ramon y Cajal</name>
      <address>
        <city>Madrid</city>
        <zip>28034</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Fundacion Jimenez</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario HM Sanchinarro</name>
      <address>
        <city>Madrid</city>
        <zip>28050</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>July 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>May 8, 2023</last_update_submitted>
  <last_update_submitted_qc>May 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Unselected solid tumors dose escalation</keyword>
  <keyword>HNSCC dose expansion</keyword>
  <keyword>Advanced stage solid tumor malignancy</keyword>
  <keyword>Unresectable</keyword>
  <keyword>Metastatic</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Squamous Cell Carcinoma of Head and Neck</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cemiplimab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing</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_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification.</ipd_time_frame>
    <ipd_access_criteria>Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency [EMA], Pharmaceuticals and Medical Devices Agency [PMDA], etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).</ipd_access_criteria>
    <ipd_url>https://vivli.org/</ipd_url>
  </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/NCT04465487
org study id: R6569-ONC-1933
secondary id: 2020-000075-20
nct id: NCT04465487
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
For dose escalation cohorts, the primary objective is to evaluate the safety and tolerability
      of REGN6569 as monotherapy lead-in and in combination with cemiplimab.

      For dose expansion cohorts, the co-primary objectives are:

        -  To assess the preliminary efficacy of REGN6569 in combination with cemiplimab, as
           measured by objective response rate (ORR)

        -  To assess the preliminary pharmacodynamic activity of REGN6569 as lead-in monotherapy,
           as measured by intratumoral Glucocorticoid-Induced Tumor necrosis factor
           receptor-Related (GITR)+ Treg depletion

      Secondary Objectives are:

      For dose escalation cohorts:

        -  To assess preliminary efficacy of REGN6569 in combination with cemiplimab, as measured
           by ORR, disease control rate (DCR), duration of response (DOR), progression-free
           survival (PFS), and overall survival (OS)

        -  To characterize the pharmacokinetics (PK) of REGN6569 alone and in combination with
           cemiplimab

        -  To assess the immunogenicity of REGN6569 and cemiplimab

      For expansion cohorts:

        -  To characterize the safety profile in each expansion cohort

        -  To assess preliminary efficacy of REGN6569 in combination with cemiplimab, as measured
           by DCR, DOR, PFS, and OS

        -  To characterize the PK of REGN6569 alone and in combination with cemiplimab

        -  To assess the immunogenicity of REGN6569 and cemiplimab
allocation: N/A
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of dose-limited toxicities (DLTs)
time frame: Up to 42 days
description: Dose escalation period
measure: Incidence and severity of treatment emergent adverse events(TEAEs)
time frame: Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months
description: Dose escalation period
measure: Incidence and severity of adverse events of special interest (AESIs)
time frame: Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months
description: Dose escalation period
measure: Incidence and severity of serious adverse events (SAEs)
time frame: Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months
description: Dose escalation period
measure: Incidence and severity of grade ≥3 laboratory abnormalities
time frame: Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months
description: Dose escalation period
measure: Objective response rate (ORR)
time frame: Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months
description: Dose expansion period
measure: Percentage change in glucocorticoid-induced tumor necrosis factor receptor-Related(GITR)+ Treg density
time frame: Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months
description: Dose expansion period
measure: ORR
time frame: Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months
description: Dose escalation period
measure: Disease control rate (DCR)
time frame: Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months
description: Dose escalation and expansion periods
measure: Duration of Response (DOR)
time frame: Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months
description: Dose escalation and expansion periods
measure: Progression-free Survival (PFS)
time frame: Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months
description: Dose escalation and expansion periods
measure: Overall survival (OS)
time frame: Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months
description: Dose escalation and expansion periods
measure: Drug concentrations of REGN6569 in serum
time frame: Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months
description: Dose escalation and expansion periods
measure: Drug concentrations of cemiplimab in serum
time frame: Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months
description: Dose escalation and expansion periods
measure: Immunogenicity as measured by anti-drug antibodies (ADA) to REGN6569
time frame: Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months
description: Dose escalation and expansion periods
measure: Immunogenicity as measured by anti-drug antibodies (ADA) to cemiplimab
time frame: Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months
description: Dose escalation and expansion periods
arm group label: REGN6569+cemiplimab
arm group type: Experimental
description: REGN6569 lead-in
intervention type: Drug
intervention name: REGN6569
description: Administered by intravenous (IV) infusion
arm group label: REGN6569+cemiplimab
intervention type: Drug
intervention name: Cemiplimab
description: Administered by IV infusion
arm group label: REGN6569+cemiplimab
other name: REGN2810
other name: Libtayo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Trial Management
role: Study Director
affiliation: Regeneron Pharmaceuticals
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Spain
country: United States
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Squamous Cell Carcinoma of Head and Neck
mesh term: Cemiplimab
sharing ipd: Yes
ipd description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
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 info type: Analytic Code
ipd time frame: Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification.
ipd access criteria: Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency [EMA], Pharmaceuticals and Medical Devices Agency [PMDA], etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).
ipd url: https://vivli.org/