<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/NCT04472429</url>
  </required_header>
  <id_info>
    <org_study_id>INCMGA 0012-303</org_study_id>
    <nct_id>NCT04472429</nct_id>
  </id_info>
  <brief_title>Carboplatin-paclitaxel With Retifanlimab or Placebo in Participants With Locally Advanced or Metastatic Squamous Cell Anal Carcinoma (POD1UM-303/InterAACT 2).</brief_title>
  <official_title>A Phase 3 Global, Multicenter, Double-Blind Randomized Study of Carboplatin-Paclitaxel With INCMGA00012 or Placebo in Participants With Inoperable Locally Recurrent or Metastatic Squamous Cell Carcinoma of the Anal Canal Not Previously Treated With Systemic Chemotherapy (POD1UM-303/InterAACT 2)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Incyte Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Incyte Corporation</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This study is a Phase 3 global, multicenter, placebo-controlled double-blind randomized study&#xD;
      that will enroll participants with inoperable locally recurrent or metastatic SCAC not&#xD;
      previously treated with systemic chemotherapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 12, 2021</start_date>
  <completion_date type="Anticipated">October 27, 2024</completion_date>
  <primary_completion_date type="Anticipated">October 24, 2024</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Double Blind</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Progression Free Survival (PFS)</measure>
    <time_frame>up to 4.5 years</time_frame>
    <description>Defined as the time from the date of randomization until disease progression according to RECIST v1.1 by BICR or death due to any cause.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>Up to 4.5 years</time_frame>
    <description>Defined as the time from the date of randomization until death due to any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Response Rate (ORR)</measure>
    <time_frame>Up to 4.5 years</time_frame>
    <description>Defined as the proportion of participants who have a confirmed complete response or partial response per RECIST v1.1 based on BICR.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response (DOR)</measure>
    <time_frame>Up to 4.5 years</time_frame>
    <description>Defined as the time from the earliest date of documented response until earliest date of disease progression (per RECIST v1.1 based on BICR) or death from any cause, whichever comes first.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease Control Rate(DCR)</measure>
    <time_frame>Up to 4.5 years</time_frame>
    <description>Defined as the number of participants maintaining either an ORR or stable disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of treatment-emergent adverse events</measure>
    <time_frame>Up to 4.5 years</time_frame>
    <description>Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study treatment up to 90 days after last dose of study treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax of retifanlimab when administered with chemotherapy</measure>
    <time_frame>Up to 4.5 years</time_frame>
    <description>Maximum observed plasma or serum concentration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>tmax of retifanlimab when administered with chemotherapy</measure>
    <time_frame>Up to 4.5 years</time_frame>
    <description>Time to maximum concentration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmin of retifanlimab when administered with chemotherapy</measure>
    <time_frame>Up to 4.5 years</time_frame>
    <description>Minimum observed plasma or serum concentration over the dose interval</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC0-t of retifanlimab when administered with chemotherapy</measure>
    <time_frame>Up to 4.5 years</time_frame>
    <description>Area under the plasma or serum concentration-time curve from time = 0 to the last measurable concentration at time = t</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">308</enrollment>
  <condition>Squamous Cell Carcinoma of the Anal Canal</condition>
  <arm_group>
    <arm_group_label>Group A : carboplatin+paclitaxel+placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will receive carboplatin on Day 1,paclitaxel on Day1,8, 15, and placebo on Day 1 of each 28 day cycle</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B : carboplatin+paclitaxel+retifanlimab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive carboplatin on Day 1,paclitaxel on Day1,8, 15, and retifanlimab on Day 1 of each 28 day cycle</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>carboplatin</intervention_name>
    <description>carboplatin will be administered intravenous on Day 1 of each 28 day cycle</description>
    <arm_group_label>Group A : carboplatin+paclitaxel+placebo</arm_group_label>
    <arm_group_label>Group B : carboplatin+paclitaxel+retifanlimab</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>paclitaxel</intervention_name>
    <description>paclitaxel will be administered intravenous on Days 1,8, and 15 of each 28 day cycle</description>
    <arm_group_label>Group A : carboplatin+paclitaxel+placebo</arm_group_label>
    <arm_group_label>Group B : carboplatin+paclitaxel+retifanlimab</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>retifanlimab</intervention_name>
    <description>retifanlimab will be administered intravenous on Day 1 of each 28 day cycle</description>
    <arm_group_label>Group B : carboplatin+paclitaxel+retifanlimab</arm_group_label>
    <other_name>INCMGA00012</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Able to comprehend and willing to sign a written ICF for the study.&#xD;
&#xD;
               -  Are 18 years of age or older (or as applicable per local country requirements).&#xD;
&#xD;
               -  Histologically or cytologically verified, inoperable locally recurrent or&#xD;
                  metastatic SCAC.&#xD;
&#xD;
               -  No prior systemic therapy other than the following: a. Chemotherapy administered&#xD;
                  concomitantly with radiotherapy as a radiosensitizing agent is permitted.&#xD;
&#xD;
                  b. Prior neoadjuvant or adjuvant therapy if completed ≥ 6 months before study&#xD;
                  entry.&#xD;
&#xD;
               -  Has measurable disease per RECIST v1.1 as determined by local site&#xD;
                  investigator/radiology assessment. Tumor lesions situated in a previously&#xD;
                  irradiated area, or in an area subjected to other loco-regional therapy, are&#xD;
                  usually not considered measurable unless there has been demonstrated progression&#xD;
                  in the lesion.&#xD;
&#xD;
               -  Able and willing to provide adequate tissue sample and whole blood sample with&#xD;
                  central testing result prior to randomization. Biopsy for archival samples should&#xD;
                  have occurred within 9 months prior to randomization.&#xD;
&#xD;
               -  ECOG performance status 0 to 1.&#xD;
&#xD;
               -  If HIV-positive, then must be stable as defined by: a. CD4+ count ≥ 200/μL, b.&#xD;
                  Undetectable viral load per standard of care assay, c. Receiving antiretroviral&#xD;
                  therapy (ART/HAART) for at least 4 weeks prior to study enrollment, and have not&#xD;
                  experienced any HIV-related opportunistic infection for at least 4 weeks prior to&#xD;
                  study enrollment.&#xD;
&#xD;
               -  Willingness to avoid pregnancy or fathering children&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has received prior PD-(L)1 directed therapy&#xD;
&#xD;
          -  Has received prior radiotherapy with or without radiosensitizing chemotherapy within&#xD;
             28 days of Cycle 1 Day 1 except for palliative radiation (30 Gy or less) which is&#xD;
             restricted for 14 days of Cycle 1 Day 1 (note: all toxicities associated should have&#xD;
             resolved to Grade ≤ 1).&#xD;
&#xD;
          -  Participants with laboratory outside of the protocol defined ranges.&#xD;
&#xD;
          -  History of second malignancy within 3 years (with exceptions).&#xD;
&#xD;
          -  Clinically significant pulmonary, cardiac, gastrointestinal or autoimmune disorders.&#xD;
&#xD;
          -  Active bacterial, fungal, or viral infections, including hepatitis A, B, and C and IV&#xD;
             antibiotic use within 7 days of Cycle 1 Day 1.&#xD;
&#xD;
          -  Receipt of a live vaccine within 28 days of planned start of study therapy.&#xD;
&#xD;
          -  History of organ transplant, including allogeneic stem cell transplantation.&#xD;
&#xD;
          -  Known active CNS metastases and/or carcinomatous meningitis.&#xD;
&#xD;
          -  Known hypersensitivity to platinum, paclitaxel, another monoclonal antibody, or any of&#xD;
             the excipients that cannot be controlled with standard measures (eg, antihistamines,&#xD;
             corticosteroids).&#xD;
&#xD;
          -  Participant is pregnant or breastfeeding.&#xD;
&#xD;
          -  Current use of protocol defined prohibited medication.&#xD;
&#xD;
          -  Has pre-existing peripheral neuropathy that is ≥ Grade 2 by CTCAE v5.&#xD;
&#xD;
          -  Inability or unlikely, in the opinion of the investigator, to comply with the Protocol&#xD;
             requirements&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The University of Arizona Cancer Center</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85724</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City of Hope National Medical Center</name>
      <address>
        <city>Duarte</city>
        <state>California</state>
        <zip>91010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UC Davis Comprehensive Cancer Center</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sansum Clinic</name>
      <address>
        <city>Santa Barbara</city>
        <state>California</state>
        <zip>93105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rocky Mountain Cancer Center</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80218</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ochsner Clinic</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maryland Oncology Hematology, P.A.</name>
      <address>
        <city>Columbia</city>
        <state>Maryland</state>
        <zip>21044</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78745</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor Scott and White Research Institute</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75246</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Renovatio Clinical Consultants Llc</name>
      <address>
        <city>The Woodlands</city>
        <state>Texas</state>
        <zip>77380</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology-Wichita Falls Texoma Cancer Center</name>
      <address>
        <city>Wichita Falls</city>
        <state>Texas</state>
        <zip>76310</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Cancer Specialists, Pc</name>
      <address>
        <city>Arlington</city>
        <state>Virginia</state>
        <zip>22205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Blue Ridge Cancer Care</name>
      <address>
        <city>Roanoke</city>
        <state>Virginia</state>
        <zip>24014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Princess Alexandra Hospital Australia</name>
      <address>
        <city>Woolloongabba</city>
        <state>Queensland</state>
        <zip>04102</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Flinders Medical Centre</name>
      <address>
        <city>Bedford Park</city>
        <state>South Australia</state>
        <zip>5042</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Monash Medical Centre Clayton</name>
      <address>
        <city>Clayton</city>
        <state>Victoria</state>
        <zip>03168</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zna Middelheim</name>
      <address>
        <city>Antwerpen</city>
        <zip>02020</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ulb Hospital Erasme</name>
      <address>
        <city>Bruxelles</city>
        <zip>01070</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Herlev Og Gentofte Hospital</name>
      <address>
        <city>Herlev</city>
        <zip>02730</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vejle Hospital</name>
      <address>
        <city>Vejle</city>
        <zip>07100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut de Cancerologie de L Ouest - Site Paul Papin</name>
      <address>
        <city>Angers Cedex 2</city>
        <zip>49055</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chu Besancon Hospital Jean Minjoz</name>
      <address>
        <city>Besançon</city>
        <zip>25030</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de Bordeaux</name>
      <address>
        <city>Bordeaux Cedex</city>
        <zip>33075</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Leon Berard</name>
      <address>
        <city>Lyon</city>
        <zip>69008</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chu Hopital de La Timone</name>
      <address>
        <city>Marseille Cedex 5</city>
        <zip>13385</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Du Cancer de Montpellier</name>
      <address>
        <city>Montpellier</city>
        <zip>34298</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Antoine Laccassagne</name>
      <address>
        <city>Nice</city>
        <zip>06200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitaire Pitie-Salpetriere</name>
      <address>
        <city>Paris Cedex 13</city>
        <zip>75651</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de La Miletrie</name>
      <address>
        <city>Poitiers Cedex</city>
        <zip>86021</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chu de Rennes - Hospital Pontchaillou</name>
      <address>
        <city>Rennes Cedex 09</city>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Charles Nicolle Chu Rouen Hospital de Bois-Guillaume</name>
      <address>
        <city>Rouen Cedex</city>
        <zip>76031</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre de Lutte Contre Le Cancer - Institut de Cancerologie de L'Ouest - Rene Gauducheau</name>
      <address>
        <city>Saint Herblain</city>
        <zip>44800</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut de Cancerologie de Strasbourg</name>
      <address>
        <city>Strasbourg</city>
        <zip>67200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chu Toulouse Hopital Rangueil</name>
      <address>
        <city>Toulouse Cedex 9</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Gustave Roussy</name>
      <address>
        <city>Villejuif Cedex</city>
        <zip>94805</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitatsklinikum Bonn Aoer</name>
      <address>
        <city>Bonn</city>
        <zip>53127</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Clinic Carl Gustav Carus Technical University Dresden</name>
      <address>
        <city>Dresden</city>
        <zip>01307</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asklepios Klinik Altona</name>
      <address>
        <city>Hamburg</city>
        <zip>22763</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori Milano</name>
      <address>
        <city>Milano</city>
        <zip>20133</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>European Institute of Oncology</name>
      <address>
        <city>Milano</city>
        <zip>20141</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda</name>
      <address>
        <city>Milano</city>
        <zip>20162</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione Irccs Ca Granda Ospedale Maggiore</name>
      <address>
        <city>Milan</city>
        <zip>20122</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda</name>
      <address>
        <city>Milan</city>
        <zip>20162</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Di Cagliari-Presidio Policlinico Monserrato</name>
      <address>
        <city>Monserrato</city>
        <zip>09042</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Universitaria University Degli Studi Della Campania Luigi Vanvitelli</name>
      <address>
        <city>Napoli</city>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Iov - Istituto Oncologico Veneto Irccs</name>
      <address>
        <city>Padova</city>
        <zip>35128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero Universitaria Pisana</name>
      <address>
        <city>Pisa</city>
        <zip>56126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Degli Infermi</name>
      <address>
        <city>Rimini</city>
        <zip>47923</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>I.R.C.C.S. Casa Sollievo Della Sofferenza</name>
      <address>
        <city>San Giovanni Rotondo</city>
        <zip>71013</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero Universitaria Ospedali Riuniti</name>
      <address>
        <city>Torrette</city>
        <zip>60020</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Center Hospital</name>
      <address>
        <city>Chuo-ku</city>
        <zip>104-0045</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyushu University Hospital</name>
      <address>
        <city>Fukuoka-shi</city>
        <zip>812-8582</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saitama Medical University International Medical Center</name>
      <address>
        <city>Hidaka-shi</city>
        <zip>350-1298</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aichi Cancer Center Hospital</name>
      <address>
        <city>Nagoya-shi</city>
        <zip>464-8681</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osaka International Cancer Institute</name>
      <address>
        <city>Osaka-shi</city>
        <zip>541-8567</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tohoku University Hospital</name>
      <address>
        <city>Sendai-shi</city>
        <zip>980-8574</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center Hospital of the National Center For Global Health and Medicine</name>
      <address>
        <city>Shinjuku-ku</city>
        <zip>162-8655</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Haukeland University Hospital</name>
      <address>
        <city>Bergen</city>
        <zip>05021</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oslo Universitetssykehus</name>
      <address>
        <city>Oslo</city>
        <zip>00450</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Panoncology Trials Pan American Center For Oncology Trials, Llc</name>
      <address>
        <city>San Juan</city>
        <zip>00935</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario Universitario A Coruna</name>
      <address>
        <city>A Coruña</city>
        <zip>15006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario Vall D Hebron</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinic de Barcelona</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario 12 de Octubre</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de La Paz</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Son Espases University Hospital</name>
      <address>
        <city>Palma de Mallorca</city>
        <zip>07120</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen Del Rocio</name>
      <address>
        <city>Sevilla</city>
        <zip>41013</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Miguel Servet</name>
      <address>
        <city>Zaragoza</city>
        <zip>50009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sahlgrenska University Hospital</name>
      <address>
        <city>Goteborg</city>
        <zip>413 45</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Skaenes Universitetssjukhus Lund</name>
      <address>
        <city>Lund</city>
        <zip>22185</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stockholm South General Hospital Sodersjukhuset</name>
      <address>
        <city>Stockholm</city>
        <zip>118 83</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Sussex County Hospital</name>
      <address>
        <city>Brighton</city>
        <zip>BN2 5BE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Addenbrooke'S Hospital</name>
      <address>
        <city>Cambridge</city>
        <zip>CB2 0QQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Surrey County Hospital</name>
      <address>
        <city>Guildford</city>
        <zip>GU2 7XX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Castle Hill Hospital</name>
      <address>
        <city>Hull</city>
        <zip>HU16 5JQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leeds Teaching Hospital</name>
      <address>
        <city>Leeds</city>
        <zip>LS 9 7TF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Free London Nhs Foundation Trust</name>
      <address>
        <city>London</city>
        <zip>NW3 2QG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Royal Marsden Nhs Foundation Trust - Chelsea</name>
      <address>
        <city>London</city>
        <zip>SW3 6JJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Christie Nhs Foundation Trust Uk</name>
      <address>
        <city>Manchester</city>
        <zip>M20 4BV</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Churchill Hospital</name>
      <address>
        <city>Oxford</city>
        <zip>OX3 7LE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Preston Hospital</name>
      <address>
        <city>Preston</city>
        <zip>PR2 9HT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Royal Marsden Nhs Foundation Trust - Sutton</name>
      <address>
        <city>Sutton</city>
        <zip>SM2 5PT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Cornwall Hospital Truro Sunrise Centre</name>
      <address>
        <city>Truro</city>
        <zip>TR1 3LQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Belgium</country>
    <country>Denmark</country>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Norway</country>
    <country>Puerto Rico</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>July 11, 2023</last_update_submitted>
  <last_update_submitted_qc>July 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 12, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Squamous cell carcinoma</keyword>
  <keyword>carboplatin</keyword>
  <keyword>paclitaxel</keyword>
  <keyword>PD-1 Inhibitor</keyword>
  <keyword>Anal Cancer</keyword>
  <keyword>SCAC</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Squamous Cell</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paclitaxel</mesh_term>
    <mesh_term>Carboplatin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.&#xD;
The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.</ipd_time_frame>
    <ipd_access_criteria>Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.</ipd_access_criteria>
    <ipd_url>https://www.incyte.com/our-company/compliance-and-transparency</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/NCT04472429
org study id: INCMGA 0012-303
nct id: NCT04472429
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This study is a Phase 3 global, multicenter, placebo-controlled double-blind randomized study
      that will enroll participants with inoperable locally recurrent or metastatic SCAC not
      previously treated with systemic chemotherapy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Double Blind
measure: Progression Free Survival (PFS)
time frame: up to 4.5 years
description: Defined as the time from the date of randomization until disease progression according to RECIST v1.1 by BICR or death due to any cause.
measure: Overall Survival (OS)
time frame: Up to 4.5 years
description: Defined as the time from the date of randomization until death due to any cause.
measure: Overall Response Rate (ORR)
time frame: Up to 4.5 years
description: Defined as the proportion of participants who have a confirmed complete response or partial response per RECIST v1.1 based on BICR.
measure: Duration of Response (DOR)
time frame: Up to 4.5 years
description: Defined as the time from the earliest date of documented response until earliest date of disease progression (per RECIST v1.1 based on BICR) or death from any cause, whichever comes first.
measure: Disease Control Rate(DCR)
time frame: Up to 4.5 years
description: Defined as the number of participants maintaining either an ORR or stable disease.
measure: Number of treatment-emergent adverse events
time frame: Up to 4.5 years
description: Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study treatment up to 90 days after last dose of study treatment.
measure: Cmax of retifanlimab when administered with chemotherapy
time frame: Up to 4.5 years
description: Maximum observed plasma or serum concentration.
measure: tmax of retifanlimab when administered with chemotherapy
time frame: Up to 4.5 years
description: Time to maximum concentration
measure: Cmin of retifanlimab when administered with chemotherapy
time frame: Up to 4.5 years
description: Minimum observed plasma or serum concentration over the dose interval
measure: AUC0-t of retifanlimab when administered with chemotherapy
time frame: Up to 4.5 years
description: Area under the plasma or serum concentration-time curve from time = 0 to the last measurable concentration at time = t
arm group label: Group A : carboplatin+paclitaxel+placebo
arm group type: Placebo Comparator
description: Participants will receive carboplatin on Day 1,paclitaxel on Day1,8, 15, and placebo on Day 1 of each 28 day cycle
arm group label: Group B : carboplatin+paclitaxel+retifanlimab
arm group type: Experimental
description: Participants will receive carboplatin on Day 1,paclitaxel on Day1,8, 15, and retifanlimab on Day 1 of each 28 day cycle
intervention type: Drug
intervention name: carboplatin
description: carboplatin will be administered intravenous on Day 1 of each 28 day cycle
arm group label: Group A : carboplatin+paclitaxel+placebo
arm group label: Group B : carboplatin+paclitaxel+retifanlimab
intervention type: Drug
intervention name: paclitaxel
description: paclitaxel will be administered intravenous on Days 1,8, and 15 of each 28 day cycle
arm group label: Group A : carboplatin+paclitaxel+placebo
arm group label: Group B : carboplatin+paclitaxel+retifanlimab
intervention type: Drug
intervention name: retifanlimab
description: retifanlimab will be administered intravenous on Day 1 of each 28 day cycle
arm group label: Group B : carboplatin+paclitaxel+retifanlimab
other name: INCMGA00012
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
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country: Australia
country: Belgium
country: Denmark
country: France
country: Germany
country: Italy
country: Japan
country: Norway
country: Puerto Rico
country: Spain
country: Sweden
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Squamous Cell
mesh term: Paclitaxel
mesh term: Carboplatin
sharing ipd: Yes
ipd description: Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
ipd access criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
ipd url: https://www.incyte.com/our-company/compliance-and-transparency