<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/NCT03836105</url>
  </required_header>
  <id_info>
    <org_study_id>R2810-ONC-1806</org_study_id>
    <nct_id>NCT03836105</nct_id>
  </id_info>
  <brief_title>CemiplimAb Survivorship Epidemiology</brief_title>
  <acronym>CASE</acronym>
  <official_title>Cemiplimab Survivorship Epidemiology (CASE) Study</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>
      The objectives of the study are:&#xD;
&#xD;
        -  To describe the effectiveness of cemiplimab 350 mg administered every 3 weeks (Q3W) for&#xD;
           treatment of patients with advanced cutaneous squamous cell carcinoma (CSCC) and&#xD;
           patients with advanced basal cell carcinoma (BCC) in real-world clinical settings&#xD;
&#xD;
        -  To evaluate the safety of cemiplimab based on incidence of treatment related&#xD;
           immune-related adverse events (irAEs), infusion related reactions (IRRs), and treatment&#xD;
           related serious adverse reactions (TSARs) in patients with advanced CSCC and patients&#xD;
           with advanced BCC receiving cemiplimab treatment in real world clinical settings&#xD;
&#xD;
        -  To describe patient experience, including patient reported quality of life (QOL) and&#xD;
           functional status, and clinician reported performance status in a real-world setting for&#xD;
           patients with advanced CSCC and patients with advanced BCC&#xD;
&#xD;
        -  To describe baseline characteristics that could potentially be associated with&#xD;
           health-related outcomes for patients with advanced CSCC and patients with advanced BCC&#xD;
           undergoing treatment with cemiplimab&#xD;
&#xD;
        -  To describe patients who receive cemiplimab as treatment for CSCC or BCC in a real-world&#xD;
           setting&#xD;
&#xD;
        -  To describe real-world use patterns of cemiplimab for CSCC and BCC&#xD;
&#xD;
        -  To investigate the long-term effects and effectiveness of cemiplimab in patients with&#xD;
           advanced CSCC or advanced BCC&#xD;
&#xD;
        -  To describe the effectiveness of cemiplimab in immunosuppressed and immunocompetent&#xD;
           patients with advanced CSCC or advanced BCC, regardless of etiology, per available data&#xD;
&#xD;
        -  To describe the effectiveness of cemiplimab after prior exposure to radiation therapy&#xD;
           for CSCC per available data&#xD;
&#xD;
        -  To describe the effectiveness of cemiplimab as a first-line (1L) or later systemic&#xD;
           treatment in patients with advanced CSCC, regardless of etiology, per available data&#xD;
&#xD;
        -  To describe the effectiveness of cemiplimab in patients with advanced BCC based on&#xD;
           treatment patterns (reason for discontinuation, treatment exposure, etc) of prior HHI&#xD;
           usage&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 27, 2019</start_date>
  <completion_date type="Anticipated">September 30, 2025</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2025</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Objective response rate (ORR)</measure>
    <time_frame>Up to 36 months</time_frame>
    <description>The rate of complete responses (CR) or partial responses (PR), as assessed by investigators</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Disease control rate (DCR)</measure>
    <time_frame>Up to 36 months</time_frame>
    <description>Percentage of patients who have achieved CR, PR or stable disease (SD) to cemiplimab as assessed by investigators</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Duration of response (DOR)</measure>
    <time_frame>Up to 36 months</time_frame>
    <description>Time from the time of initial response until documented tumor progress, death, or initiation of non-cemiplimab CSCC or BCC treatment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to response</measure>
    <time_frame>Up to 36 months</time_frame>
    <description>Time from date of first admission of cemiplimab to the initial response</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Progression free survival (PFS)</measure>
    <time_frame>Up to 36 months</time_frame>
    <description>Time from the date of first administration of cemiplimab to progression or death from any cause, whichever occurs first</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>Up to 36 months</time_frame>
    <description>Time from the date of first administration of cemiplimab to the date of death due to any cause</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to treatment failure (TTTF)</measure>
    <time_frame>Up to 36 months</time_frame>
    <description>Time from date of first administration of cemiplimab to treatment discontinuation for disease progression, treatment toxicity, or death</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Disease specific death (DSD)</measure>
    <time_frame>Up to 36 months</time_frame>
    <description>Rate of death cause by or related to underlying CSCC or BCC as assessed by investigators</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with metastatic vs locally advanced cancer summarized every three weeks</measure>
    <time_frame>Up to 36 months</time_frame>
    <description>Pattern of recurrence</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Immune related adverse events (irAEs)</measure>
    <time_frame>Up to 36 months</time_frame>
    <description>Per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Infusion related reactions (IRRs)</measure>
    <time_frame>Up to 36 months</time_frame>
    <description>NCI-CTCAE v5</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Treatment related serious adverse reactions (SARs)</measure>
    <time_frame>Up to 36 months</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Cutaneous Squamous Cell Carcinoma</condition>
  <condition>Basal Cell Carcinoma</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>cemiplimab</intervention_name>
    <description>No investigational agents will be provided to enrolled patients by the sponsor as part of this study. Patients will have recently initiated or be planning to initiate treatment with commercially available cemiplimab for advanced CSCC or advanced BCC in a real-world setting according to respective label indications. In addition to cemiplimab, patients may receive other therapies as deemed necessary by their physicians for the treatment of CSCC or BCC or comorbid conditions.</description>
    <other_name>REGN2810</other_name>
    <other_name>Libtayo</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients in this study will include men and women ≥18 years of age who have recently&#xD;
        initiated, or who plan to initiate treatment with commercially available cemiplimab for&#xD;
        CSCC or BCC in a real-world setting.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  Eligible for treatment with and prescribed cemiplimab for advanced CSCC or advanced&#xD;
             BCC in accordance with approved prescribing information as described in the protocol&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  Receiving cemiplimab for an indication other than advanced CSCC or advanced BCC&#xD;
&#xD;
          -  Any condition that, in the opinion of the investigator, may interfere with patient's&#xD;
             ability to participate in the study&#xD;
&#xD;
          -  Patients concurrently participating in any study including administration of any&#xD;
             investigational drug (including cemiplimab) or procedure (including survival follow&#xD;
             up)&#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 Pharmaceutical, Inc.</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Medical Affairs</last_name>
    <phone>844-734-6643</phone>
    <email>clinicaltrials@regeneron.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Oncology Specialties, PC - Clearview Cancer Institute</name>
      <address>
        <city>Huntsville</city>
        <state>Alabama</state>
        <zip>35805</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Dignity Health St. Joseph's Hospital and Medical Center</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85013</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>CARTI Cancer Center</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72205</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of California San Diego</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92037</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Harbor-UCLA/LA Biomedical Research Institute</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90502</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>St. Mary's Medical Center</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94117</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Regeneron Research Facility</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94063</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>University of Colorado</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>The Melanoma and Skin Cancer Institute</name>
      <address>
        <city>Englewood</city>
        <state>Colorado</state>
        <zip>80113</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Regional Cancer Care Associates, LLC</name>
      <address>
        <city>Manchester</city>
        <state>Connecticut</state>
        <zip>06040</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Integrity Clinical Research</name>
      <address>
        <city>Delray Beach</city>
        <state>Florida</state>
        <zip>33745</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32224</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Regeneron Research Facility</name>
      <address>
        <city>Largo</city>
        <state>Florida</state>
        <zip>33770</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Regeneron Research Facility</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33156</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Miami Cancer Institute at Baptist Health, Inc.</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33176</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Moffitt Cancer Center</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Lewis Hall Singletary Oncology Center at John D. Archbold Memorial Hospital</name>
      <address>
        <city>Thomasville</city>
        <state>Georgia</state>
        <zip>31792</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Northwestern University</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>NorthShore University HealthSystem</name>
      <address>
        <city>Evanston</city>
        <state>Illinois</state>
        <zip>60201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Reid Oncology Association</name>
      <address>
        <city>Richmond</city>
        <state>Indiana</state>
        <zip>47374</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>CHRISTUS Highland Cancer Treatment Center</name>
      <address>
        <city>Shreveport</city>
        <state>Louisiana</state>
        <zip>71105</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Baltimore Veterans Affairs Medical Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Frederick Health</name>
      <address>
        <city>Frederick</city>
        <state>Maryland</state>
        <zip>21702</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Dana-Farber Cancer Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Lahey Hospital &amp; Medical Center</name>
      <address>
        <city>Burlington</city>
        <state>Massachusetts</state>
        <zip>01805</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </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>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Southeast Nebraska Hematology &amp; Oncology Consultants, PC</name>
      <address>
        <city>Lincoln</city>
        <state>Nebraska</state>
        <zip>68510</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Optum Cancer Care</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89102</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Regeneron Research Facility</name>
      <address>
        <city>Elizabeth</city>
        <state>New Jersey</state>
        <zip>07202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Montefiore Hospital</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10461</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Roswell Park Cancer Institute</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14203</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Regeneron Research Facility</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Regeneron Research Facility</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Regeneron Research Facility</name>
      <address>
        <city>Nyack</city>
        <state>New York</state>
        <zip>10960</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>New York Cancer and Blood Specialists</name>
      <address>
        <city>Port Jefferson Station</city>
        <state>New York</state>
        <zip>11776</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Oncology Specialists of Charlotte, PA</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28204</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Durham VA Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27705</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Asante Rogue Regional Medical Center</name>
      <address>
        <city>Medford</city>
        <state>Oregon</state>
        <zip>97504</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Oregon Health &amp; Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>St. Luke's University Health Network</name>
      <address>
        <city>Bethlehem</city>
        <state>Pennsylvania</state>
        <zip>18015</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Center of the Carolinas</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29407</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Charleston Hematology Oncology Associates, PA</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29414</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Tennessee Medical Center</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37920</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Texas Oncology-Amarillo Cancer Center</name>
      <address>
        <city>Amarillo</city>
        <state>Texas</state>
        <zip>79106</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Texas Oncology</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75246</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Texas Southwestern</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Renovatio Clinical</name>
      <address>
        <city>The Woodlands</city>
        <state>Texas</state>
        <zip>77380</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Vermont</name>
      <address>
        <city>Burlington</city>
        <state>Vermont</state>
        <zip>05401</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Virginia</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22908</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Inova Schar Cancer Institute</name>
      <address>
        <city>Fairfax</city>
        <state>Virginia</state>
        <zip>22031</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Pan-American Center for Oncology Trials, LLC</name>
      <address>
        <city>Rio Piedras</city>
        <zip>00902</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>FDI Clinical Research</name>
      <address>
        <city>San Juan</city>
        <zip>00927</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Puerto Rico</country>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>February 7, 2019</study_first_submitted>
  <study_first_submitted_qc>February 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 11, 2019</study_first_posted>
  <last_update_submitted>December 14, 2022</last_update_submitted>
  <last_update_submitted_qc>December 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Advanced CSCC</keyword>
  <keyword>Advanced BCC</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Basal Cell</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 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, EMA, 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/NCT03836105
org study id: R2810-ONC-1806
nct id: NCT03836105
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The objectives of the study are:

        -  To describe the effectiveness of cemiplimab 350 mg administered every 3 weeks (Q3W) for
           treatment of patients with advanced cutaneous squamous cell carcinoma (CSCC) and
           patients with advanced basal cell carcinoma (BCC) in real-world clinical settings

        -  To evaluate the safety of cemiplimab based on incidence of treatment related
           immune-related adverse events (irAEs), infusion related reactions (IRRs), and treatment
           related serious adverse reactions (TSARs) in patients with advanced CSCC and patients
           with advanced BCC receiving cemiplimab treatment in real world clinical settings

        -  To describe patient experience, including patient reported quality of life (QOL) and
           functional status, and clinician reported performance status in a real-world setting for
           patients with advanced CSCC and patients with advanced BCC

        -  To describe baseline characteristics that could potentially be associated with
           health-related outcomes for patients with advanced CSCC and patients with advanced BCC
           undergoing treatment with cemiplimab

        -  To describe patients who receive cemiplimab as treatment for CSCC or BCC in a real-world
           setting

        -  To describe real-world use patterns of cemiplimab for CSCC and BCC

        -  To investigate the long-term effects and effectiveness of cemiplimab in patients with
           advanced CSCC or advanced BCC

        -  To describe the effectiveness of cemiplimab in immunosuppressed and immunocompetent
           patients with advanced CSCC or advanced BCC, regardless of etiology, per available data

        -  To describe the effectiveness of cemiplimab after prior exposure to radiation therapy
           for CSCC per available data

        -  To describe the effectiveness of cemiplimab as a first-line (1L) or later systemic
           treatment in patients with advanced CSCC, regardless of etiology, per available data

        -  To describe the effectiveness of cemiplimab in patients with advanced BCC based on
           treatment patterns (reason for discontinuation, treatment exposure, etc) of prior HHI
           usage
observational model: Cohort
time perspective: Prospective
measure: Objective response rate (ORR)
time frame: Up to 36 months
description: The rate of complete responses (CR) or partial responses (PR), as assessed by investigators
measure: Disease control rate (DCR)
time frame: Up to 36 months
description: Percentage of patients who have achieved CR, PR or stable disease (SD) to cemiplimab as assessed by investigators
measure: Duration of response (DOR)
time frame: Up to 36 months
description: Time from the time of initial response until documented tumor progress, death, or initiation of non-cemiplimab CSCC or BCC treatment
measure: Time to response
time frame: Up to 36 months
description: Time from date of first admission of cemiplimab to the initial response
measure: Progression free survival (PFS)
time frame: Up to 36 months
description: Time from the date of first administration of cemiplimab to progression or death from any cause, whichever occurs first
measure: Overall Survival (OS)
time frame: Up to 36 months
description: Time from the date of first administration of cemiplimab to the date of death due to any cause
measure: Time to treatment failure (TTTF)
time frame: Up to 36 months
description: Time from date of first administration of cemiplimab to treatment discontinuation for disease progression, treatment toxicity, or death
measure: Disease specific death (DSD)
time frame: Up to 36 months
description: Rate of death cause by or related to underlying CSCC or BCC as assessed by investigators
measure: Number of patients with metastatic vs locally advanced cancer summarized every three weeks
time frame: Up to 36 months
description: Pattern of recurrence
measure: Immune related adverse events (irAEs)
time frame: Up to 36 months
description: Per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5
measure: Infusion related reactions (IRRs)
time frame: Up to 36 months
description: NCI-CTCAE v5
measure: Treatment related serious adverse reactions (SARs)
time frame: Up to 36 months
intervention type: Drug
intervention name: cemiplimab
description: No investigational agents will be provided to enrolled patients by the sponsor as part of this study. Patients will have recently initiated or be planning to initiate treatment with commercially available cemiplimab for advanced CSCC or advanced BCC in a real-world setting according to respective label indications. In addition to cemiplimab, patients may receive other therapies as deemed necessary by their physicians for the treatment of CSCC or BCC or comorbid conditions.
other name: REGN2810
other name: Libtayo
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Trial Management
role: Study Director
affiliation: Regeneron Pharmaceutical, Inc.
last name: Medical Affairs
phone: 844-734-6643
email: clinicaltrials@regeneron.com
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Completed
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Completed
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
country: Puerto Rico
country: United States
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Basal Cell
mesh term: Cemiplimab
sharing ipd: Yes
ipd description: All 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, EMA, 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/