<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/NCT03233139</url>
  </required_header>
  <id_info>
    <org_study_id>R2810-ONC-1622</org_study_id>
    <nct_id>NCT03233139</nct_id>
  </id_info>
  <brief_title>Safety and Pharmacokinetics of Cemiplimab Anti-programmed Death-ligand 1 (Anti-PD-1) and Other Agents in Japanese Adult Patients With Advanced Malignancies</brief_title>
  <official_title>A Phase 1 Study to Investigate the Safety and Pharmacokinetics of Cemiplimab (Anti-PD-1) and Other Agents in Japanese Patients With Advanced 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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Part 2 Cohorts A and C This study is being conducted to test the safety and pharmacokinetics&#xD;
      of cemiplimab in patients with lung cancer. The study is also being conducted to test if&#xD;
      cemiplimab, alone or in combination, can reduce the size of your tumor by helping the immune&#xD;
      system destroy the tumor.&#xD;
&#xD;
      Part 2 Cohorts D and E This study is being conducted to test the safety and pharmacokinetics&#xD;
      of fianlimab and cemiplimab in patients with lung cancer. The study is also being conducted&#xD;
      to test if fianlimab and cemiplimab, with or without chemotherapy, can reduce the size of&#xD;
      your tumor by helping the immune system destroy the tumor.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 21, 2017</start_date>
  <completion_date type="Anticipated">March 27, 2030</completion_date>
  <primary_completion_date type="Anticipated">December 22, 2027</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>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence and severity of treatment-emergent adverse events (TEAEs) in patients treated with cemiplimab as monotherapy</measure>
    <time_frame>Up to 136 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence and severity of TEAEs in patients treated with cemiplimab in combination with other agents</measure>
    <time_frame>Up to 136 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence and severity of TEAEs in patients treated with fianlimab in combination with cemiplimab without chemotherapy</measure>
    <time_frame>Up to 136 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence and severity of TEAEs in patients treated with fianlimab in combination with cemiplimab with chemotherapy</measure>
    <time_frame>Up to 136 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>PK of cemiplimab: Cmax</measure>
    <time_frame>Up to 136 weeks</time_frame>
    <description>Peak serum concentration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PK of cemiplimab: tmax</measure>
    <time_frame>Up to 136 weeks</time_frame>
    <description>Time to Cmax</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PK of cemiplimab: Ctrough</measure>
    <time_frame>Up to 136 weeks</time_frame>
    <description>Drug concentration in serum at the end of a dosing interval</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PK of cemiplimab: Area under the drug concentration-time curve in serum (AUC3w)</measure>
    <time_frame>Up to 136 weeks</time_frame>
    <description>AUC over a 3-week dosing interval</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PK of cemiplimab: t½ estimated over a 3-week dosing interval</measure>
    <time_frame>Up to 136 weeks</time_frame>
    <description>Observed terminal half-life</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Immunogenicity against cemiplimab and fianlimab</measure>
    <time_frame>Up to 136 weeks</time_frame>
    <description>Evaluate the immunogenicity of cemiplimab and fianlimab after single-dose administration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective Response Rate (ORR)</measure>
    <time_frame>Up to 135 weeks</time_frame>
    <description>As assessed by an Independent Review Committee (IRC) using RECIST 1.1 (Eisenhauer 2009) in Part 2, Cohorts A and C</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response (DOR)</measure>
    <time_frame>Up to 136 weeks</time_frame>
    <description>As assessed by an IRC (per RECIST1.1) in Part 2, Cohorts A and C</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Anticipated">145</enrollment>
  <condition>Advanced Malignancies</condition>
  <arm_group>
    <arm_group_label>Cemiplimab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Part 1</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Part 2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Part 2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Part 2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort D</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Part 2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort E</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Part 2</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cemiplimab</intervention_name>
    <description>Patients will be administered cemiplimab as per protocol. For Cohort A Only, patients with confirmed progressive disease may opt to receive up to 4 cycles of platinum doublet chemotherapy in addition to cemiplimab per investigator's judgement.</description>
    <arm_group_label>Cemiplimab</arm_group_label>
    <arm_group_label>Cohort A</arm_group_label>
    <arm_group_label>Cohort B</arm_group_label>
    <arm_group_label>Cohort C</arm_group_label>
    <arm_group_label>Cohort D</arm_group_label>
    <arm_group_label>Cohort E</arm_group_label>
    <other_name>REGN2810</other_name>
    <other_name>Libtayo</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ipilimumab</intervention_name>
    <description>To be administered per protocol</description>
    <arm_group_label>Cohort B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Platinum-doublet chemotherapy</intervention_name>
    <description>To be administered per protocol</description>
    <arm_group_label>Cohort B</arm_group_label>
    <arm_group_label>Cohort C</arm_group_label>
    <arm_group_label>Cohort E</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gemcitabine</intervention_name>
    <description>To be administered per protocol</description>
    <arm_group_label>Cohort B</arm_group_label>
    <other_name>Gemzar</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pemetrexed</intervention_name>
    <description>To be administered per protocol</description>
    <arm_group_label>Cohort B</arm_group_label>
    <arm_group_label>Cohort C</arm_group_label>
    <arm_group_label>Cohort E</arm_group_label>
    <other_name>Alimta</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paclitaxel</intervention_name>
    <description>To be administered per protocol</description>
    <arm_group_label>Cohort B</arm_group_label>
    <arm_group_label>Cohort C</arm_group_label>
    <arm_group_label>Cohort E</arm_group_label>
    <other_name>Taxol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fianlimab</intervention_name>
    <description>To be administered per protocol</description>
    <arm_group_label>Cohort D</arm_group_label>
    <arm_group_label>Cohort E</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          1. Disease types under study:&#xD;
&#xD;
               -  Part 1: Histologically or cytologically confirmed diagnosis of malignancy with no&#xD;
                  alternative standard-of-care therapeutic option&#xD;
&#xD;
               -  Part 2: Patients with histologically or cytologically documented squamous or&#xD;
                  non-squamous NSCLC with stage IIIB or IIIC or stage IV disease who received no&#xD;
                  prior systemic treatment for recurrent or metastatic NSCLC.&#xD;
&#xD;
               -  Patients in Part 2 NSCLC cohorts must have available archival or newly obtained&#xD;
                  formalin-fixed tumor tissue from a metastatic/recurrent site, which has not&#xD;
                  previously been irradiated.&#xD;
&#xD;
          2. ECOG (Eastern Cooperative Oncology Group) PS (Performance status) ≤1 (Restricted in&#xD;
             physically strenuous activity but ambulatory and able to carry out work of a light or&#xD;
             sedentary nature [eg, light housework or office work]). Note: Patients with ECOG PS &gt;1&#xD;
             are ineligible.&#xD;
&#xD;
          3. Patients must have been born in Japan, and their biological parents and grandparents&#xD;
             must all have been of Japanese origin&#xD;
&#xD;
          4. Willing and able to comply with clinic visits and study-related procedures&#xD;
&#xD;
          5. For Part 2, Cohorts D and E: Available tissue for retrospective testing using assay&#xD;
             performed by a central laboratory, as specified in the study manual.&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          1. Ongoing or recent (within 5 years) evidence of significant autoimmune disease that&#xD;
             requires treatment with systemic immunosuppressive treatments, which may suggest risk&#xD;
             for Immune-mediated adverse event (imAE)s. The following are not exclusionary:&#xD;
             vitiligo, childhood asthma that has resolved, residual hypothyroidism that requires&#xD;
             only hormone replacement or psoriasis that does not require systemic treatment.&#xD;
&#xD;
          2. Untreated brain metastasis (es) that may be considered active. Patients with&#xD;
             previously treated brain metastases may participate provided they are stable, there is&#xD;
             no evidence of new or enlarging brain metastases, and the patient does not require any&#xD;
             systemic corticosteroids for management of brain metastases within 4 weeks prior to&#xD;
             the first dose of cemiplimab.&#xD;
&#xD;
          3. Immunosuppressive corticosteroid doses (&gt;10 mg prednisone daily or equivalent) within&#xD;
             4 weeks prior to the first dose of cemiplimab.&#xD;
&#xD;
          4. Any positive test (ribonucleic acid (RNA) or Deoxyribonucleic acid (DNA) by polymerase&#xD;
             chain reaction) for hepatitis B, hepatitis C, or human immunodeficiency virus&#xD;
             indicating uncontrolled active or chronic infection.&#xD;
&#xD;
          5. History of pneumonitis or interstitial lung disease&#xD;
&#xD;
          6. Surgery within 1 month of first dose and radiation therapy within 2 weeks of first&#xD;
             dose&#xD;
&#xD;
          7. Completed palliative radiation therapy within the prior 2 weeks or has not recovered&#xD;
             from any medically significant radiation-related Adverse Event (AE)&#xD;
&#xD;
          8. Patients that have never smoked, defined as smoking ≤100 cigarettes in a lifetime&#xD;
             (Part 2)&#xD;
&#xD;
          9. Patients with tumors tested positive for epidermal growth factor receptor (EGFR) gene&#xD;
             mutations, anaplastic lymphoma kinase (ALK) gene translocations, or ROS1 fusions (Part&#xD;
             2)&#xD;
&#xD;
        Note: Other protocol defined inclusion/exclusion criteria apply.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 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>
  <overall_contact>
    <last_name>Clinical Trials Administrator</last_name>
    <phone>844-734-6643</phone>
    <email>clinicaltrials@regeneron.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Nagoya Medical Center</name>
      <address>
        <city>Nagoya</city>
        <state>Aichi</state>
        <zip>460-0001</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kurume University Hospital</name>
      <address>
        <city>Kurume</city>
        <state>Fukuoka</state>
        <zip>830-0011</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kobe City Medical Center General Hospital</name>
      <address>
        <city>Kobe</city>
        <state>Hyogo</state>
        <zip>650-0047</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kanazawa University Hospital</name>
      <address>
        <city>Kanazawa</city>
        <state>Ishikawa</state>
        <zip>920-8641</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kitasato University Hospital</name>
      <address>
        <city>Sagamihara</city>
        <state>Kanagawa</state>
        <zip>252-0375</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kanagawa Cardiovascular and Respiratory Center</name>
      <address>
        <city>Yokohama</city>
        <state>Kanagawa</state>
        <zip>236-0051</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kanagawa Cancer Center</name>
      <address>
        <city>Yokohama</city>
        <state>Kanagawa</state>
        <zip>241-8515</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Sasebo City General Hospital</name>
      <address>
        <city>Sasebo</city>
        <state>Nagasaki</state>
        <zip>857-8511</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kurashiki Central Hospital</name>
      <address>
        <city>Kurashiki</city>
        <state>Okayama</state>
        <zip>710-8515</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kansai Medical University Hospital</name>
      <address>
        <city>Hirakata</city>
        <state>Osaka</state>
        <zip>573-1191</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kinki-Chuo Chest Medical Center</name>
      <address>
        <city>Sakai</city>
        <state>Osaka</state>
        <zip>591-8555</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Osaka Medical College Hospital</name>
      <address>
        <city>Takatsuki</city>
        <state>Osaka</state>
        <zip>569-8686</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Saitama Cancer Center</name>
      <address>
        <city>Kita Adachi</city>
        <state>Saitama</state>
        <zip>362-0806</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>National Cancer Center Hospital</name>
      <address>
        <city>Cho-Ku</city>
        <state>Tokyo</state>
        <zip>104-0055</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Tokyo Medical University Hospital</name>
      <address>
        <city>Shinjuku</city>
        <state>Tokyo</state>
        <zip>160-0023</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Gunma Prefectural Cancer Center</name>
      <address>
        <city>Gunma</city>
        <zip>373-8550</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hiroshima City Hiroshima Citizens Hospital</name>
      <address>
        <city>Hiroshima</city>
        <zip>730-8518</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Nagasaki University Hospital</name>
      <address>
        <city>Nagasaki</city>
        <zip>852-8501</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Osaka International Cancer Center</name>
      <address>
        <city>Osaka</city>
        <zip>541-8567</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Osaka City University Hospital</name>
      <address>
        <city>Osaka</city>
        <zip>545-8586</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Tokushima University Hospital</name>
      <address>
        <city>Tokushima</city>
        <zip>770-8503</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>July 25, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2017</study_first_posted>
  <last_update_submitted>September 14, 2023</last_update_submitted>
  <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Japanese patients</keyword>
  <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>Paclitaxel</mesh_term>
    <mesh_term>Gemcitabine</mesh_term>
    <mesh_term>Pemetrexed</mesh_term>
    <mesh_term>Ipilimumab</mesh_term>
    <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/NCT03233139
org study id: R2810-ONC-1622
nct id: NCT03233139
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
Part 2 Cohorts A and C This study is being conducted to test the safety and pharmacokinetics
      of cemiplimab in patients with lung cancer. The study is also being conducted to test if
      cemiplimab, alone or in combination, can reduce the size of your tumor by helping the immune
      system destroy the tumor.

      Part 2 Cohorts D and E This study is being conducted to test the safety and pharmacokinetics
      of fianlimab and cemiplimab in patients with lung cancer. The study is also being conducted
      to test if fianlimab and cemiplimab, with or without chemotherapy, can reduce the size of
      your tumor by helping the immune system destroy the tumor.
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence and severity of treatment-emergent adverse events (TEAEs) in patients treated with cemiplimab as monotherapy
time frame: Up to 136 weeks
measure: Incidence and severity of TEAEs in patients treated with cemiplimab in combination with other agents
time frame: Up to 136 weeks
measure: Incidence and severity of TEAEs in patients treated with fianlimab in combination with cemiplimab without chemotherapy
time frame: Up to 136 weeks
measure: Incidence and severity of TEAEs in patients treated with fianlimab in combination with cemiplimab with chemotherapy
time frame: Up to 136 weeks
measure: PK of cemiplimab: Cmax
time frame: Up to 136 weeks
description: Peak serum concentration
measure: PK of cemiplimab: tmax
time frame: Up to 136 weeks
description: Time to Cmax
measure: PK of cemiplimab: Ctrough
time frame: Up to 136 weeks
description: Drug concentration in serum at the end of a dosing interval
measure: PK of cemiplimab: Area under the drug concentration-time curve in serum (AUC3w)
time frame: Up to 136 weeks
description: AUC over a 3-week dosing interval
measure: PK of cemiplimab: t½ estimated over a 3-week dosing interval
time frame: Up to 136 weeks
description: Observed terminal half-life
measure: Immunogenicity against cemiplimab and fianlimab
time frame: Up to 136 weeks
description: Evaluate the immunogenicity of cemiplimab and fianlimab after single-dose administration
measure: Objective Response Rate (ORR)
time frame: Up to 135 weeks
description: As assessed by an Independent Review Committee (IRC) using RECIST 1.1 (Eisenhauer 2009) in Part 2, Cohorts A and C
measure: Duration of Response (DOR)
time frame: Up to 136 weeks
description: As assessed by an IRC (per RECIST1.1) in Part 2, Cohorts A and C
arm group label: Cemiplimab
arm group type: Experimental
description: Part 1
arm group label: Cohort A
arm group type: Experimental
description: Part 2
arm group label: Cohort B
arm group type: Experimental
description: Part 2
arm group label: Cohort C
arm group type: Experimental
description: Part 2
arm group label: Cohort D
arm group type: Experimental
description: Part 2
arm group label: Cohort E
arm group type: Experimental
description: Part 2
intervention type: Drug
intervention name: Cemiplimab
description: Patients will be administered cemiplimab as per protocol. For Cohort A Only, patients with confirmed progressive disease may opt to receive up to 4 cycles of platinum doublet chemotherapy in addition to cemiplimab per investigator's judgement.
arm group label: Cemiplimab
arm group label: Cohort A
arm group label: Cohort B
arm group label: Cohort C
arm group label: Cohort D
arm group label: Cohort E
other name: REGN2810
other name: Libtayo
intervention type: Drug
intervention name: Ipilimumab
description: To be administered per protocol
arm group label: Cohort B
intervention type: Drug
intervention name: Platinum-doublet chemotherapy
description: To be administered per protocol
arm group label: Cohort B
arm group label: Cohort C
arm group label: Cohort E
intervention type: Drug
intervention name: Gemcitabine
description: To be administered per protocol
arm group label: Cohort B
other name: Gemzar
intervention type: Drug
intervention name: Pemetrexed
description: To be administered per protocol
arm group label: Cohort B
arm group label: Cohort C
arm group label: Cohort E
other name: Alimta
intervention type: Drug
intervention name: Paclitaxel
description: To be administered per protocol
arm group label: Cohort B
arm group label: Cohort C
arm group label: Cohort E
other name: Taxol
intervention type: Drug
intervention name: Fianlimab
description: To be administered per protocol
arm group label: Cohort D
arm group label: Cohort E
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Trial Management
role: Study Director
affiliation: Regeneron Pharmaceuticals
last name: Clinical Trials Administrator
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: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
country: Japan
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Paclitaxel
mesh term: Gemcitabine
mesh term: Pemetrexed
mesh term: Ipilimumab
mesh term: Cemiplimab