<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/NCT03005782</url>
  </required_header>
  <id_info>
    <org_study_id>R3767-ONC-1613</org_study_id>
    <secondary_id>2016-002789-30</secondary_id>
    <nct_id>NCT03005782</nct_id>
  </id_info>
  <brief_title>Study of REGN3767 (Anti-LAG-3) With or Without REGN2810 (Anti-PD1) in Advanced Cancers</brief_title>
  <official_title>A Phase 1, Open-Label, Dose-Escalation and Cohort Expansion First-in-Human Study of the Safety, Tolerability, Activity and Pharmacokinetics of REGN3767 (Anti-LAG-3 mAb) Administered Alone or in Combination With REGN2810 (Anti-PD-1 mAb) in Patients With Advanced Malignancies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Regeneron Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sanofi</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Regeneron Pharmaceuticals</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objectives in the dose escalation phase are to evaluate safety and&#xD;
      pharmacokinetics (PK) in order to determine the selected dose level(s) for expansion of&#xD;
      REGN3767 as monotherapy and in combination with cemiplimab in patients with advanced&#xD;
      malignancies, including lymphoma.&#xD;
&#xD;
      The primary objectives in the dose expansion phase are to assess preliminary anti-tumor&#xD;
      activity of REGN3767 alone and in combination with cemiplimab (separately by cohort) as&#xD;
      measured by objective response rate (ORR).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">November 7, 2016</start_date>
  <completion_date type="Anticipated">January 27, 2025</completion_date>
  <primary_completion_date type="Anticipated">January 27, 2025</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of dose limiting toxicities (Dose Escalation Phase)</measure>
    <time_frame>Baseline to 28 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of adverse events (Dose Escalation Phase)</measure>
    <time_frame>Baseline to 51 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of serious adverse events (Dose Escalation Phase)</measure>
    <time_frame>Baseline to 51 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Occurrence of death (Dose Escalation Phase)</measure>
    <time_frame>Baseline to 51 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with laboratory abnormalities (grade 3 or higher per Common Terminology Criteria for Adverse Events [CTCAE]) (Dose Escalation Phase)</measure>
    <time_frame>Baseline to 51 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the curve (AUC) computed from time zero to the time of the last concentration [AUCall] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)</measure>
    <time_frame>Baseline to 51 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>AUCall-to-dose ratio [AUCall/Dose] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)</measure>
    <time_frame>Baseline to 51 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC from time zero extrapolated to infinity [AUCinf] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)</measure>
    <time_frame>Baseline to 51 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>AUCinf-to-dose ratio [AUCinf/dose] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)</measure>
    <time_frame>Baseline to 51 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC computed from time zero to the time of the last positive concentration [AUClast] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)</measure>
    <time_frame>Baseline to 51 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>AUClast-to-dose ratio [AUClast/dose] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)</measure>
    <time_frame>Baseline to 51 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Clearance [CL] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)</measure>
    <time_frame>Baseline to 51 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum Plasma Concentration [Cmax] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)</measure>
    <time_frame>Baseline to week 51</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax-to-dose ratio [Cmax/dose] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)</measure>
    <time_frame>Baseline to 51 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Last positive (quantifiable) concentration [Clast] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)</measure>
    <time_frame>Baseline to 51 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean residence time extrapolated to infinity [MRTinf] (Dose Escalation Phase)</measure>
    <time_frame>Baseline to 51 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean residence time when the drug concentration profile is based on values up to and including the last positive concentration [MRTlast] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)</measure>
    <time_frame>Baseline to 51 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Observed terminal half-life [t1/2] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)</measure>
    <time_frame>Baseline to 51 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>t1/2 beta (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)</measure>
    <time_frame>Baseline to 51 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Time of the last positive (quantifiable) concentration [tlast] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)</measure>
    <time_frame>Baseline to 51 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to Cmax [tmax] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)</measure>
    <time_frame>Baseline to 51 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Volume of distribution at steady state [Vss] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)</measure>
    <time_frame>Baseline to 51 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Volume of distribution of the terminal phase [Vz] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)</measure>
    <time_frame>Baseline to 51 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Objective response rate based on RECIST 1.1 for Solid Tumors (Dose Expansion phase)</measure>
    <time_frame>Baseline to 51 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Objective response rate by Lugano criteria for Lymphoma (Dose Expansion Phase)</measure>
    <time_frame>Baseline to 51 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Objective response rate per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (solid tumors) (Dose Escalation Phase)</measure>
    <time_frame>Baseline to week 51</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective response rate per Lugano criteria (lymphomas) (Dose Escalation Phase)</measure>
    <time_frame>Baseline to week 51</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Best overall response based on RECIST 1.1 criteria (Dose Escalation Phase)</measure>
    <time_frame>Baseline to 51 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Best overall response based on irRECIST criteria (Dose Escalation Phase)</measure>
    <time_frame>Baseline to 51 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Best overall response based on Lugano criteria (Dose Escalation Phase)</measure>
    <time_frame>Baseline to 51 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of response based on RECIST criteria (Dose Escalation Phase)</measure>
    <time_frame>Baseline to week 51</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of response based on irRECIST criteria (Dose Escalation Phase)</measure>
    <time_frame>Baseline to week 51</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of response based on Lugano criteria (Dose Escalation Phase)</measure>
    <time_frame>Baseline to week 51</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease control rate based on RECIST criteria (Dose Escalation Phase)</measure>
    <time_frame>Baseline to 51 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease control rate based on irRECIST criteria (Dose Escalation Phase)</measure>
    <time_frame>Baseline to 51 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease control rate based on Lugano criteria (Dose Escalation Phase)</measure>
    <time_frame>Baseline to 51 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression free survival based on RECIST (Dose Escalation Phase)</measure>
    <time_frame>Baseline to 51 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression free survival based on irRECIST (Dose Escalation Phase)</measure>
    <time_frame>Baseline to 51 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression free survival based on Lugano criteria (Dose Escalation Phase)</measure>
    <time_frame>Baseline to 51 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse events (Dose Expansion Phase)</measure>
    <time_frame>Baseline to 51 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of serious adverse events (Dose Expansion Phase)</measure>
    <time_frame>Baseline to 51 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of death (Dose Expansion Phase)</measure>
    <time_frame>From Baseline to the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 42 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with laboratory abnormalities (grade 3 or higher per Common Terminology Criteria for Adverse Events [CTCAE]) (Dose Expansion Phase)</measure>
    <time_frame>Baseline to 51 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of anti-drug antibodies (Dose Escalation Phase and Dose Expansion Phase)</measure>
    <time_frame>Baseline to 51 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">333</enrollment>
  <condition>Malignancies</condition>
  <arm_group>
    <arm_group_label>Monotherapy (REGN3767)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group A will consist of up to 4 sequential dose cohorts. Each cohort will receive 1 of 3 ascending dose levels of study drug during dose escalation. In addition 1 tumor-specific cohort will be treated at the recommended phase 2 dose (RP2D) during dose expansion.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Combination Therapy (REGN3767+cemiplimab)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group B will consist of up to 4 sequential dose cohorts. Each cohort will receive 1 of 3 ascending dose levels of study drug during dose escalation. In addition, 9 tumor-specific cohorts will be treated at the RP2D during dose expansion</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>REGN3767</intervention_name>
    <arm_group_label>Combination Therapy (REGN3767+cemiplimab)</arm_group_label>
    <arm_group_label>Monotherapy (REGN3767)</arm_group_label>
    <other_name>fianlimab</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>cemiplimab</intervention_name>
    <arm_group_label>Combination Therapy (REGN3767+cemiplimab)</arm_group_label>
    <other_name>REGN2810</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  Dose escalation cohorts: Patients with histologically or cytologically confirmed&#xD;
             diagnosis of malignancy (including lymphoma) with demonstrated progression of a tumor&#xD;
             for whom there is no available therapy likely to convey clinical benefit AND who have&#xD;
             not been previously treated with a PD-1/PD-L1 inhibitor. These patients do not require&#xD;
             measurable disease&#xD;
&#xD;
          -  Dose expansion cohorts: Patients with histologically or cytologically confirmed&#xD;
             diagnosis of 1 of specified tumors with measurable disease per RECIST 1.1 or Lugano&#xD;
             criteria. Some patients may have been previously treated with a PD-1 or PD-L1&#xD;
             inhibitor&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group performance status of 0 or 1&#xD;
&#xD;
          -  Adequate organ and bone marrow function&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  Prior treatment with any LAG-3 targeting biologic or small molecule&#xD;
&#xD;
          -  Radiation therapy within 2 weeks prior to randomization and not recovered to baseline&#xD;
             from any AE due to radiation&#xD;
&#xD;
          -  Untreated or active central nervous system metastases - Ongoing or recent (within 5&#xD;
             years) evidence of significant autoimmune disease&#xD;
&#xD;
          -  Corticosteroid therapy (&gt;10 mg prednisone/day or equivalent) within 1 week prior to&#xD;
             the first dose of study drug&#xD;
&#xD;
          -  Myocardial infarction within 6 months&#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>California Cancer Associates for Research and Excellence</name>
      <address>
        <city>Encinitas</city>
        <state>California</state>
        <zip>92024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>California Cancer Associates For Research And Excellence</name>
      <address>
        <city>Fresno</city>
        <state>California</state>
        <zip>93720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California San Diego (UCSD)</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92093-0698</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Angeles Clinic</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90025</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California Davis Health Systems</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>California Pacific Medical Center (CPMC)</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado Cancer Center</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lombardi Comprehensive Cancer Center - MedStar Georgetown University Hospital</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Miami Cancer Institute</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33176</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orlando Health, Inc</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Winship Cancer Institute at Emory University</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Kansas Clinical Research Center</name>
      <address>
        <city>Fairway</city>
        <state>Kansas</state>
        <zip>66205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dana Farber Cancer Institute</name>
      <address>
        <city>Jamaica Plain</city>
        <state>Massachusetts</state>
        <zip>02130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry Ford Health Hospital</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer and Hematology Centers of Western Michigan</name>
      <address>
        <city>Grand Rapids</city>
        <state>Michigan</state>
        <zip>49503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University in Saint Louis</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>John Theurer Cancer Center, Hackensack University Medical Center</name>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <zip>07601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rutgers Cancer Institute of New Jersey</name>
      <address>
        <city>New Brunswick</city>
        <state>New Jersey</state>
        <zip>08903</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Mexico Cancer Care Alliance-UNM Cancer Center</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Roswell Park Cancer Institute</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14263</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwell Health-Monter Cancer Center</name>
      <address>
        <city>Lake Success</city>
        <state>New York</state>
        <zip>11042</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Laura &amp; Isaac Perlmutter Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia University</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan-Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Levine Cancer Institute</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals Seidman Cancer Center and Case Western Reserve University</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44087</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stephenson Cancer Center</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rhode Island Hospital</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02903</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hollings Cancer Center - Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sarah Cannon Research Institute</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Texas MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Texas Oncology and Hematology</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Cancer Care Specialist, PC</name>
      <address>
        <city>Fairfax</city>
        <state>Virginia</state>
        <zip>22031</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Western Australia - The Queen Elizabeth II Medical Centre (QEIIMC) - Sir Charles Gairdner Hospital (SCGH)</name>
      <address>
        <city>Perth</city>
        <state>Western Australia</state>
        <zip>06009</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Brisbane and Women's Hospital</name>
      <address>
        <city>Brisbane</city>
        <zip>4029</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peter Maccallum Cancer Centre (PMCC)</name>
      <address>
        <city>Melbourne</city>
        <zip>3000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Vincents University Hospital</name>
      <address>
        <city>Dublin</city>
        <zip>D04 T6F4</zip>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Severance Hospital, Yonsei University Health System</name>
      <address>
        <city>Seoul</city>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>06351</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guy's Hospital</name>
      <address>
        <city>London</city>
        <state>Europe</state>
        <zip>SE19RT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Of Oxford - Churchill Hospital</name>
      <address>
        <city>Headington</city>
        <state>Oxford</state>
        <zip>OX37LJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Ireland</country>
    <country>Korea, Republic of</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>November 18, 2016</study_first_submitted>
  <study_first_submitted_qc>December 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 29, 2016</study_first_posted>
  <last_update_submitted>August 25, 2022</last_update_submitted>
  <last_update_submitted_qc>August 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 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>Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cemiplimab</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03005782
org study id: R3767-ONC-1613
secondary id: 2016-002789-30
nct id: NCT03005782
lead sponsor: 
collaborator: 
has dmc: Yes
The primary objectives in the dose escalation phase are to evaluate safety and
      pharmacokinetics (PK) in order to determine the selected dose level(s) for expansion of
      REGN3767 as monotherapy and in combination with cemiplimab in patients with advanced
      malignancies, including lymphoma.

      The primary objectives in the dose expansion phase are to assess preliminary anti-tumor
      activity of REGN3767 alone and in combination with cemiplimab (separately by cohort) as
      measured by objective response rate (ORR).
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Rate of dose limiting toxicities (Dose Escalation Phase)
time frame: Baseline to 28 days
measure: Rate of adverse events (Dose Escalation Phase)
time frame: Baseline to 51 weeks
measure: Rate of serious adverse events (Dose Escalation Phase)
time frame: Baseline to 51 weeks
measure: Occurrence of death (Dose Escalation Phase)
time frame: Baseline to 51 weeks
measure: Number of patients with laboratory abnormalities (grade 3 or higher per Common Terminology Criteria for Adverse Events [CTCAE]) (Dose Escalation Phase)
time frame: Baseline to 51 weeks
measure: Area under the curve (AUC) computed from time zero to the time of the last concentration [AUCall] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
time frame: Baseline to 51 weeks
measure: AUCall-to-dose ratio [AUCall/Dose] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
time frame: Baseline to 51 weeks
measure: AUC from time zero extrapolated to infinity [AUCinf] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
time frame: Baseline to 51 weeks
measure: AUCinf-to-dose ratio [AUCinf/dose] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
time frame: Baseline to 51 weeks
measure: AUC computed from time zero to the time of the last positive concentration [AUClast] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
time frame: Baseline to 51 weeks
measure: AUClast-to-dose ratio [AUClast/dose] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
time frame: Baseline to 51 weeks
measure: Clearance [CL] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
time frame: Baseline to 51 weeks
measure: Maximum Plasma Concentration [Cmax] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
time frame: Baseline to week 51
measure: Cmax-to-dose ratio [Cmax/dose] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
time frame: Baseline to 51 weeks
measure: Last positive (quantifiable) concentration [Clast] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
time frame: Baseline to 51 weeks
measure: Mean residence time extrapolated to infinity [MRTinf] (Dose Escalation Phase)
time frame: Baseline to 51 weeks
measure: Mean residence time when the drug concentration profile is based on values up to and including the last positive concentration [MRTlast] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
time frame: Baseline to 51 weeks
measure: Observed terminal half-life [t1/2] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
time frame: Baseline to 51 weeks
measure: t1/2 beta (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
time frame: Baseline to 51 weeks
measure: Time of the last positive (quantifiable) concentration [tlast] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
time frame: Baseline to 51 weeks
measure: Time to Cmax [tmax] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
time frame: Baseline to 51 weeks
measure: Volume of distribution at steady state [Vss] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
time frame: Baseline to 51 weeks
measure: Volume of distribution of the terminal phase [Vz] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
time frame: Baseline to 51 weeks
measure: Objective response rate based on RECIST 1.1 for Solid Tumors (Dose Expansion phase)
time frame: Baseline to 51 weeks
measure: Objective response rate by Lugano criteria for Lymphoma (Dose Expansion Phase)
time frame: Baseline to 51 weeks
measure: Objective response rate per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (solid tumors) (Dose Escalation Phase)
time frame: Baseline to week 51
measure: Objective response rate per Lugano criteria (lymphomas) (Dose Escalation Phase)
time frame: Baseline to week 51
measure: Best overall response based on RECIST 1.1 criteria (Dose Escalation Phase)
time frame: Baseline to 51 weeks
measure: Best overall response based on irRECIST criteria (Dose Escalation Phase)
time frame: Baseline to 51 weeks
measure: Best overall response based on Lugano criteria (Dose Escalation Phase)
time frame: Baseline to 51 weeks
measure: Duration of response based on RECIST criteria (Dose Escalation Phase)
time frame: Baseline to week 51
measure: Duration of response based on irRECIST criteria (Dose Escalation Phase)
time frame: Baseline to week 51
measure: Duration of response based on Lugano criteria (Dose Escalation Phase)
time frame: Baseline to week 51
measure: Disease control rate based on RECIST criteria (Dose Escalation Phase)
time frame: Baseline to 51 weeks
measure: Disease control rate based on irRECIST criteria (Dose Escalation Phase)
time frame: Baseline to 51 weeks
measure: Disease control rate based on Lugano criteria (Dose Escalation Phase)
time frame: Baseline to 51 weeks
measure: Progression free survival based on RECIST (Dose Escalation Phase)
time frame: Baseline to 51 weeks
measure: Progression free survival based on irRECIST (Dose Escalation Phase)
time frame: Baseline to 51 weeks
measure: Progression free survival based on Lugano criteria (Dose Escalation Phase)
time frame: Baseline to 51 weeks
measure: Incidence of adverse events (Dose Expansion Phase)
time frame: Baseline to 51 weeks
measure: Incidence of serious adverse events (Dose Expansion Phase)
time frame: Baseline to 51 weeks
measure: Incidence of death (Dose Expansion Phase)
time frame: From Baseline to the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 42 months
measure: Number of patients with laboratory abnormalities (grade 3 or higher per Common Terminology Criteria for Adverse Events [CTCAE]) (Dose Expansion Phase)
time frame: Baseline to 51 weeks
measure: Incidence of anti-drug antibodies (Dose Escalation Phase and Dose Expansion Phase)
time frame: Baseline to 51 weeks
arm group label: Monotherapy (REGN3767)
arm group type: Experimental
description: Group A will consist of up to 4 sequential dose cohorts. Each cohort will receive 1 of 3 ascending dose levels of study drug during dose escalation. In addition 1 tumor-specific cohort will be treated at the recommended phase 2 dose (RP2D) during dose expansion.
arm group label: Combination Therapy (REGN3767+cemiplimab)
arm group type: Experimental
description: Group B will consist of up to 4 sequential dose cohorts. Each cohort will receive 1 of 3 ascending dose levels of study drug during dose escalation. In addition, 9 tumor-specific cohorts will be treated at the RP2D during dose expansion
intervention type: Drug
intervention name: REGN3767
arm group label: Combination Therapy (REGN3767+cemiplimab)
arm group label: Monotherapy (REGN3767)
other name: fianlimab
intervention type: Drug
intervention name: cemiplimab
arm group label: Combination Therapy (REGN3767+cemiplimab)
other name: REGN2810
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
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country: Australia
country: Ireland
country: Korea, Republic of
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Cemiplimab