<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/NCT04486378</url>
  </required_header>
  <id_info>
    <org_study_id>BNT122-01</org_study_id>
    <secondary_id>2020-000451-12</secondary_id>
    <secondary_id>U1111-1250-5294</secondary_id>
    <nct_id>NCT04486378</nct_id>
  </id_info>
  <brief_title>A Phase II Clinical Trial Comparing the Efficacy of RO7198457 Versus Watchful Waiting in Patients With ctDNA-positive, Resected Stage II (High Risk) and Stage III Colorectal Cancer</brief_title>
  <official_title>A Multi-site, Open-label, Phase II, Randomized, Controlled Trial to Compare the Efficacy of RO7198457 Versus Watchful Waiting in Resected, Stage II (High Risk) and Stage III Colorectal Cancer Patients Who Are ctDNA Positive Following Resection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>BioNTech SE</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>BioNTech SE</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 is a multi-site, open-label, Phase II, randomized, trial to compare the efficacy of&#xD;
      RO7198457 versus watchful waiting in patients with circulating tumor DNA (ctDNA) positive,&#xD;
      surgically resected Stage II/III rectal cancer, or Stage II (high risk)/Stage III colon&#xD;
      cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 8, 2021</start_date>
  <completion_date type="Anticipated">July 2027</completion_date>
  <primary_completion_date type="Anticipated">September 2023</primary_completion_date>
  <phase>Phase 2</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Disease-free survival (DFS)</measure>
    <time_frame>Through study completion, up to 5 years</time_frame>
    <description>DFS defined as the time from randomization to occurrence of any of the following events, whichever occurs first:&#xD;
Locoregional recurrence or distant metastases as determined by an independent central radiology assessment.&#xD;
Occurrence of second primary (same or other) cancer as determined by an independent central radiology assessment.&#xD;
Death from any cause.&#xD;
Loss to follow-up is censored.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Relapse-free survival (RFS)</measure>
    <time_frame>Through study completion, up to 5 years</time_frame>
    <description>RFS is defined as the time from randomization to occurrence of any of the following events, whichever occurs first:&#xD;
Locoregional recurrence or distant metastases as determined by the investigator.&#xD;
Death from any cause.&#xD;
Occurrence of second primary (same or other) cancer as determined by the investigator is ignored.&#xD;
Loss to follow-up is censored.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to recurrence (TTR)</measure>
    <time_frame>Through study completion, up to 5 years</time_frame>
    <description>TTR is defined as the time from randomization to occurrence of any of the following events (i.e., events related to the same cancer), whichever occurs first:&#xD;
Locoregional recurrence or distant metastases as determined by the investigator.&#xD;
Death from same cancer.&#xD;
Occurrence of second primary (same or other) cancer as determined by the investigator is ignored.&#xD;
Loss to follow-up and deaths from other cancer, non-cancer-related deaths, treatment-related deaths are censored.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to treatment failure (TTF)</measure>
    <time_frame>Through study completion, up to 5 years</time_frame>
    <description>TTF is defined as the time from randomization to occurrence of any of the following events, whichever occurs first:&#xD;
Locoregional recurrence or distant metastases as determined by the investigator.&#xD;
Occurrence of second primary (same or other) cancer as determined by the investigator.&#xD;
Death from any cause except non-cancer related death.&#xD;
Loss to follow-up and non-cancer-related deaths are censored.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>Through study completion, up to 5 years</time_frame>
    <description>OS defined as the time from randomization to death from any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Circulating tumor DNA (ctDNA) status (every 3 months)</measure>
    <time_frame>Through study completion, up to 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of treatment emergent adverse event (TEAE)</measure>
    <time_frame>15 months</time_frame>
    <description>TEAE, including Grade 3+, serious, fatal TEAE by relationship (AEs graded according to the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events, version 5.0 [CTCAE v5.0])</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of dose reduction and discontinuation of IMP due to a TEAE.</measure>
    <time_frame>15 months</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">201</enrollment>
  <condition>Colorectal Cancer Stage II</condition>
  <condition>Colorectal Cancer Stage III</condition>
  <arm_group>
    <arm_group_label>RO7198457</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive a recommended dose of RO7198457.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Observational Group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Observational group will undergo watchful waiting, which is the standard of care in this setting.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Biomarker Cohort</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>15 patients</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Exploratory Cohort</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>20 patients</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>RO7198457 intravenous (i.v.)</intervention_name>
    <description>RO7198457 administered as an IV injection at protocol-specified intervals over 12 months.</description>
    <arm_group_label>Biomarker Cohort</arm_group_label>
    <arm_group_label>Exploratory Cohort</arm_group_label>
    <arm_group_label>RO7198457</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Observational group (no intervention)</intervention_name>
    <description>watchful waiting</description>
    <arm_group_label>Observational Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients must be a man or woman of at least 18 years of age.&#xD;
&#xD;
          -  Patients must have Stage II/Stage III rectal cancer or Stage II (high risk)/Stage III&#xD;
             colon cancer per AJCC 2017 that has been surgically totally resected (R0 confirmed by&#xD;
             pathology report). Stage II (high risk) colon cancer is defined as Stage II disease&#xD;
             with any of the following risk factors for recurrence:&#xD;
&#xD;
               -  T4&#xD;
&#xD;
               -  Grade ≥ 3.&#xD;
&#xD;
               -  Clinical presentation with bowel obstruction or perforation.&#xD;
&#xD;
               -  Histological signs of vascular, lymphatic or perineural invasion.&#xD;
&#xD;
               -  &lt; 12 nodes examined.&#xD;
&#xD;
          -  Patients must have detectable ctDNA prior to start of adjuvant chemotherapy (AdCTx)&#xD;
             (except for the Biomarker Cohort).&#xD;
&#xD;
             • ctDNA assay must be performed through this trial or study BNT000-001 ctDNA screening&#xD;
             protocol.&#xD;
&#xD;
          -  Patients must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of&#xD;
             0-1.&#xD;
&#xD;
          -  Patients must have adequate hematologic and organ function.&#xD;
&#xD;
          -  Adequate tumor material in formalin-fixed paraffin embedded (FFPE) blocks or as&#xD;
             sectioned tissue (only upon approval by sponsor) must be available (as described in&#xD;
             the laboratory manual).&#xD;
&#xD;
          -  The patient has started a standard of care AdCTx within 8 weeks post-surgery and has&#xD;
             completed at least 3 months of treatment of a 3 or a 6 month course of chemotherapy&#xD;
             (including rest days).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with uncontrolled intercurrent illness.&#xD;
&#xD;
          -  Diagnosed microsatellite instability (MSI) high tumors.&#xD;
&#xD;
          -  Prior therapy with any of the following:&#xD;
&#xD;
               -  Neo-adjuvant (radio)chemotherapy prior to surgery.&#xD;
&#xD;
               -  Treatment with systemic immunosuppressive medication within 2 weeks prior to&#xD;
                  initiation of trial treatment or anticipation of need for systemic&#xD;
                  immunosuppressive medication during trial treatment, with the exception of low&#xD;
                  dose steroids defined as 10 mg oral prednisone (or equivalent).&#xD;
&#xD;
               -  Current or recent (within the 28 days prior to randomization) treatment with&#xD;
                  another investigational drug.&#xD;
&#xD;
          -  Toxicities from previous anti-cancer therapies that have not resolved to baseline&#xD;
             levels or to Grade 1 or less except for alopecia and peripheral neuropathy.&#xD;
&#xD;
          -  Patients who developed metastatic disease during screening/receiving standard of care&#xD;
             treatment (not applicable for Exploratory Cohort).&#xD;
&#xD;
          -  Patients with known past or current malignancy other than inclusion diagnosis, except&#xD;
             for:&#xD;
&#xD;
               -  Cervical carcinoma of Stage 1B or less.&#xD;
&#xD;
               -  Non-invasive basal cell or squamous cell skin carcinoma.&#xD;
&#xD;
               -  Non-invasive, superficial bladder cancer.&#xD;
&#xD;
               -  Prostate cancer with a current PSA level &lt; 0.1 ng/mL.&#xD;
&#xD;
               -  Any curable cancer with a complete response (CR) of &gt; 2 years duration.&#xD;
&#xD;
          -  Patients with known allergies, hypersensitivity, or intolerance to RO7198457 or its&#xD;
             excipients.&#xD;
&#xD;
          -  Patients who had major surgery (e.g., surgery requiring general anesthesia) within 4&#xD;
             weeks before screening, or will not have fully recovered from surgery, or have surgery&#xD;
             planned during the time the patient are expected to participate in the trial.&#xD;
&#xD;
          -  Patients with active hepatitis B or C.&#xD;
&#xD;
          -  Patients who have a history of human immunodeficiency virus (HIV) antibody positivity,&#xD;
             or tests positive for HIV at screening.&#xD;
&#xD;
          -  Patients who have had prior splenectomy.&#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>BioNTech Responsible Person</last_name>
    <role>Study Director</role>
    <affiliation>BioNTech SE</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>BioNTech clinical trials patient information</last_name>
    <phone>+49 6131 9084</phone>
    <phone_ext>0</phone_ext>
    <email>patients@biontech.de</email>
  </overall_contact>
  <location>
    <facility>
      <name>Mayo Clinic - Scottsdale</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85259</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>John Muir Clinical Research Center</name>
      <address>
        <city>Concord</city>
        <state>California</state>
        <zip>94520</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>The Oncology Institute of Hope and Innovation</name>
      <address>
        <city>Glendale</city>
        <state>California</state>
        <zip>91204</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Marin Cancer Care</name>
      <address>
        <city>Greenbrae</city>
        <state>California</state>
        <zip>94904</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>St Joseph Hospital of Orange</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Sansum Clinic</name>
      <address>
        <city>Santa Barbara</city>
        <state>California</state>
        <zip>93105</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Florida Cancer Specialist South</name>
      <address>
        <city>Fort Myers</city>
        <state>Florida</state>
        <zip>33916</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic Florida</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32224</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Florida Cancer Specialists</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <zip>33401</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Cancer Care Center of Decatur, Cancer Care Specialists of IL</name>
      <address>
        <city>Decatur</city>
        <state>Illinois</state>
        <zip>62526</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Kansas Cancer Center</name>
      <address>
        <city>Westwood</city>
        <state>Kansas</state>
        <zip>66205</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Louisville - James Graham Brown Cancer Center</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Josephine Ford Cancer Center-Henry Ford Cancer Center</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>New York Oncology Hematology, P.C.</name>
      <address>
        <city>Albany</city>
        <state>New York</state>
        <zip>12206</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>New York - Presbyterian Hospital - Columbia University Medical center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic Rochester</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Oncology Hematology Care Clinical Trials</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45245</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Willamette Valley Cancer Institute and Research Center</name>
      <address>
        <city>Eugene</city>
        <state>Oregon</state>
        <zip>97401</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Sarah Cannon (Tennessee Oncology - Nashville</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Texas Oncology, P.A. - Austin</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78705</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Texas Oncology-Baylor Charles A. Sammons Cancer Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75246</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </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>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Texas Oncology-San Antonio Medical Center</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78240</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Texas Oncology - Northeast Texas</name>
      <address>
        <city>Tyler</city>
        <state>Texas</state>
        <zip>75702</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Virginia Cancer Specialists</name>
      <address>
        <city>Fairfax</city>
        <state>Virginia</state>
        <zip>22031</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Benaroya Research Institute at Virginia Mason</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98101</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Washington</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>MultiCare Institute for Research &amp; Innovation</name>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>99218</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Northwest Cancer Specialists P.C.</name>
      <address>
        <city>Vancouver</city>
        <state>Washington</state>
        <zip>98684</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Imeldaziekenhuis General Hospital</name>
      <address>
        <city>Bonheiden</city>
        <zip>2820</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>VZW Algemeen Ziekenhuis AZ Klina</name>
      <address>
        <city>Brasschaat</city>
        <zip>2930</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Institut Jules Bordet</name>
      <address>
        <city>Brussel</city>
        <zip>1070</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>GHDC (Grand Hopital de Charleroi)</name>
      <address>
        <city>Charleroi</city>
        <zip>6000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>AZ Groeninge</name>
      <address>
        <city>Kortrijk</city>
        <zip>8500</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Centres Hospitaliers Jolimont</name>
      <address>
        <city>La Louviere</city>
        <zip>7100</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Universitaire Ziekenhuizen Leuven</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>AZ Delta Roeselare</name>
      <address>
        <city>Roeselare</city>
        <zip>8800</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>GasthuisZusters Antwerpen - Sint-Augustinus</name>
      <address>
        <city>Wilrijk</city>
        <zip>2610</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-Luc</name>
      <address>
        <city>Woluwe-Saint-Lambert</city>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Charité - Universitätsmedizin Berlin</name>
      <address>
        <city>Berlin</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum St. Josef-Hospital Bochum</name>
      <address>
        <city>Bochum</city>
        <zip>44791</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Bonn, Med. Klinik u. Poliklinik I</name>
      <address>
        <city>Bonn</city>
        <zip>53105</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Klinikum Esslingen GmbH</name>
      <address>
        <city>Esslingen</city>
        <zip>73730</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Krankenhaus Nordwest GmbH - Institut Fuer Klinisch-Onkologische Forschung (IKF)</name>
      <address>
        <city>Frankfurt am Main</city>
        <zip>60488</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Klinikum der Johann Wolfgang Goethe-Universitaet Frankfurt</name>
      <address>
        <city>Frankfurt am Main</city>
        <zip>60590</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Studiengesellschaft BSF</name>
      <address>
        <city>Halle</city>
        <zip>06108</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Hamburg-Eppendorf</name>
      <address>
        <city>Hamburg</city>
        <zip>20246</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hämatologisch-Onkologische Praxis Eppendorf</name>
      <address>
        <city>Hamburg</city>
        <zip>20249</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Asklepios Klinik Altona</name>
      <address>
        <city>Hamburg</city>
        <zip>22763</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Medizinische Hochschule Hannover</name>
      <address>
        <city>Hannover</city>
        <zip>30625</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>National Center for Tumor Diseases (NCT) Heidelberg</name>
      <address>
        <city>Heidelberg</city>
        <zip>69120</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>SLK-Kliniken Heilbronn GmbH</name>
      <address>
        <city>Heilbronn</city>
        <zip>74078</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Staedtisches Krankenhaus Kiel gGmbH</name>
      <address>
        <city>Kiel</city>
        <zip>24116</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Leipzig AoeR</name>
      <address>
        <city>Leipzig</city>
        <zip>04103</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz KoeR</name>
      <address>
        <city>Mainz</city>
        <zip>55131</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Klinikum der Philipps-Universität Marburg</name>
      <address>
        <city>Marburg</city>
        <zip>35043</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>LMU Klinikum (Campus Großhadern) Medizinische Klinik Universität München</name>
      <address>
        <city>München</city>
        <zip>81377</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Städtisches Klinikum München GmbH, Klinikum Neuperlach</name>
      <address>
        <city>München</city>
        <zip>81737</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>OhO Ostholstein Onkologie</name>
      <address>
        <city>Oldenburg In Holstein</city>
        <zip>23758</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Prosper Hospital</name>
      <address>
        <city>Recklinghausen</city>
        <zip>45659</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Robert-Bosch-Krankenhaus - Centrum fuer Tumorerkrankungen</name>
      <address>
        <city>Stuttgart</city>
        <zip>70376</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Ulm</name>
      <address>
        <city>Ulm</city>
        <zip>89081</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Würzburg</name>
      <address>
        <city>Würzburg</city>
        <zip>97080</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario Universitario A Coruna</name>
      <address>
        <city>A Coruna</city>
        <zip>15006</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Nuestra Senora de Sonsoles</name>
      <address>
        <city>Avila</city>
        <zip>05004</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Germans Trias - ICO Badalona</name>
      <address>
        <city>Badalona</city>
        <zip>08916</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Vall d'Hebron</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Institut Clinic Hematolo/Oncologia- ICMHO, Hospital Clinic i Provincial de Barcelona</name>
      <address>
        <city>Barcelona</city>
        <zip>8036</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital de la Santa Creu i Sant Pau</name>
      <address>
        <city>Barcelona</city>
        <zip>8041</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Reina Sofia</name>
      <address>
        <city>Cordoba</city>
        <zip>14004</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario Gregorio Maranon</name>
      <address>
        <city>Madrid</city>
        <zip>28007</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinica Universidad Navarra</name>
      <address>
        <city>Madrid</city>
        <zip>28027</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Ramón y Cajal</name>
      <address>
        <city>Madrid</city>
        <zip>28034</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico San Carlos</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Fundacion Jimenez Diaz</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario La Paz</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario HMN Sanchinarro, Centro Integral Oncologico Clara Campal (CIOCC)</name>
      <address>
        <city>Madrid</city>
        <zip>28050</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Puerta de Hierro de Majadahonda</name>
      <address>
        <city>Majadahonda</city>
        <zip>28222</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Regional Universitario Carlos Haya Malaga - Instituto de Investigacion Biomedica de Malaga</name>
      <address>
        <city>Málaga</city>
        <zip>29011</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario de Orense</name>
      <address>
        <city>Orense</city>
        <zip>32005</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinica Universitaria de Navarra</name>
      <address>
        <city>Pamplona</city>
        <zip>31008</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario de Navarra (CHN)</name>
      <address>
        <city>Pamplona</city>
        <zip>31008</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Marques De Valdecilla</name>
      <address>
        <city>Santander</city>
        <zip>39008</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario Universitario De Santiago De Compostela</name>
      <address>
        <city>Santiago De Compostela</city>
        <zip>15706</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen del Rocio - Hospital de la Mujer</name>
      <address>
        <city>Sevilla</city>
        <zip>41013</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Consorcio Hospital General Valencia</name>
      <address>
        <city>Valencia</city>
        <zip>46014</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Complexo Hospitalario Universitario de Vigo (CHUVI)</name>
      <address>
        <city>Vigo</city>
        <zip>36312</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Miguel Servet</name>
      <address>
        <city>Zaragoza</city>
        <zip>50009</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Lunds Universitet - Medicinska Fakulteten (Lund University Faculty of Medicine)</name>
      <address>
        <city>Lund</city>
        <zip>221 00</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Sodersjukhuset, Onkologiska Kliniken</name>
      <address>
        <city>Stockholm</city>
        <zip>11883</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Karolinska Universitetssjukhuset Solna</name>
      <address>
        <city>Stockholm</city>
        <zip>17176</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>The Clatterbridge Cancer Centre NHS Foundation Trust</name>
      <address>
        <city>Bebington</city>
        <zip>CH63 4JY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Queen Elizabeth Hospital Birmingham-University Hospitals Birmingham NHS Foundation Trust</name>
      <address>
        <city>Birmingham</city>
        <zip>B15 2GW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Velindre NHS Trust, Velindre Cancer Centre</name>
      <address>
        <city>Cardiff</city>
        <zip>CF14 2TL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University College London Hospitals NHS Foundation Trust</name>
      <address>
        <city>London</city>
        <zip>NW2 1PG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </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>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>The Christie NHS Foundation Trust</name>
      <address>
        <city>Manchester</city>
        <zip>M20 4BX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>The Royal Marsden NHS Foundation Trust</name>
      <address>
        <city>Sutton</city>
        <zip>SM25NG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Germany</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 20, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>July 31, 2023</last_update_submitted>
  <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cancer</keyword>
  <keyword>Colorectal Cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04486378
org study id: BNT122-01
secondary id: 2020-000451-12
secondary id: U1111-1250-5294
nct id: NCT04486378
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is a multi-site, open-label, Phase II, randomized, trial to compare the efficacy of
      RO7198457 versus watchful waiting in patients with circulating tumor DNA (ctDNA) positive,
      surgically resected Stage II/III rectal cancer, or Stage II (high risk)/Stage III colon
      cancer.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Disease-free survival (DFS)
time frame: Through study completion, up to 5 years
description: DFS defined as the time from randomization to occurrence of any of the following events, whichever occurs first:
Locoregional recurrence or distant metastases as determined by an independent central radiology assessment.
Occurrence of second primary (same or other) cancer as determined by an independent central radiology assessment.
Death from any cause.
Loss to follow-up is censored.
measure: Relapse-free survival (RFS)
time frame: Through study completion, up to 5 years
description: RFS is defined as the time from randomization to occurrence of any of the following events, whichever occurs first:
Locoregional recurrence or distant metastases as determined by the investigator.
Death from any cause.
Occurrence of second primary (same or other) cancer as determined by the investigator is ignored.
Loss to follow-up is censored.
measure: Time to recurrence (TTR)
time frame: Through study completion, up to 5 years
description: TTR is defined as the time from randomization to occurrence of any of the following events (i.e., events related to the same cancer), whichever occurs first:
Locoregional recurrence or distant metastases as determined by the investigator.
Death from same cancer.
Occurrence of second primary (same or other) cancer as determined by the investigator is ignored.
Loss to follow-up and deaths from other cancer, non-cancer-related deaths, treatment-related deaths are censored.
measure: Time to treatment failure (TTF)
time frame: Through study completion, up to 5 years
description: TTF is defined as the time from randomization to occurrence of any of the following events, whichever occurs first:
Locoregional recurrence or distant metastases as determined by the investigator.
Occurrence of second primary (same or other) cancer as determined by the investigator.
Death from any cause except non-cancer related death.
Loss to follow-up and non-cancer-related deaths are censored.
measure: Overall survival (OS)
time frame: Through study completion, up to 5 years
description: OS defined as the time from randomization to death from any cause.
measure: Change of Circulating tumor DNA (ctDNA) status (every 3 months)
time frame: Through study completion, up to 5 years
measure: Occurrence of treatment emergent adverse event (TEAE)
time frame: 15 months
description: TEAE, including Grade 3+, serious, fatal TEAE by relationship (AEs graded according to the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events, version 5.0 [CTCAE v5.0])
measure: Occurrence of dose reduction and discontinuation of IMP due to a TEAE.
time frame: 15 months
arm group label: RO7198457
arm group type: Experimental
description: Participants will receive a recommended dose of RO7198457.
arm group label: Observational Group
arm group type: Other
description: Observational group will undergo watchful waiting, which is the standard of care in this setting.
arm group label: Biomarker Cohort
arm group type: Experimental
description: 15 patients
arm group label: Exploratory Cohort
arm group type: Experimental
description: 20 patients
intervention type: Drug
intervention name: RO7198457 intravenous (i.v.)
description: RO7198457 administered as an IV injection at protocol-specified intervals over 12 months.
arm group label: Biomarker Cohort
arm group label: Exploratory Cohort
arm group label: RO7198457
intervention type: Other
intervention name: Observational group (no intervention)
description: watchful waiting
arm group label: Observational Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: BioNTech Responsible Person
role: Study Director
affiliation: BioNTech SE
last name: BioNTech clinical trials patient information
phone: +49 6131 9084
phone ext: 0
email: patients@biontech.de
facility: 
status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
country: Belgium
country: Germany
country: Spain
country: Sweden
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Colorectal Neoplasms
sharing ipd: No