[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635186":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":39,"centralContacts":44,"locations":54,"responsibleParty":140,"collaborators":142,"id":145,"slug":146,"hasResults":147,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":11,"eligibilityCriteria":151,"healthyVolunteers":147,"sex":152,"minAge":153,"maxAge":11,"enrollmentInfo":154,"targetDuration":11,"studyType":157,"phases":158,"briefSummary":160,"conditions":161,"keywords":163,"overallStatus":57,"whyStopped":11,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":177},{"fullName":5,"class":6},"EMD Serono","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1: Precemtabart tocentecan (Precem-TcT) Monotherapy","EXPERIMENTAL",null,[13],"Drug: Precemtabart tocentecan",{"label":15,"type":10,"description":11,"interventionNames":16},"Arm 2: Precem-TcT plus Bevacizumab",[13,17],"Drug: Bevacizumab",{"label":19,"type":20,"description":11,"interventionNames":21},"Arm 3: Trifluridine\u002FTipiracil (FTD-TPI) plus Bevacizumab","ACTIVE_COMPARATOR",[17,22],"Drug: Trifluridine\u002FTipiracil (FTD-TPI)",[24,31,35],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","Precemtabart tocentecan","Precem-TcT, administered, once every 3 weeks intravenously, on Day 1 of each 21-day cycle.",[9,15],[30],"Precem-TcT",{"type":25,"name":32,"description":33,"armGroupLabels":34,"otherNames":11},"Bevacizumab","Bevacizumab, administered intravenously every 3 weeks on Day 1 of each 21-day cycle or every 2 weeks on Day 1 and Day 15 of each 28-day cycle.",[15,19],{"type":25,"name":36,"description":37,"armGroupLabels":38,"otherNames":11},"Trifluridine\u002FTipiracil (FTD-TPI)","FTD-TPI, tablet, administered orally twice daily, on Days 1 to 5 and Days 8 to 12 of each 28-day cycle.",[19],[40],{"name":41,"affiliation":42,"role":43},"Medical Responsible","EMD Serono Research & Development Institute, Inc.","STUDY_DIRECTOR",[45,50],{"name":46,"role":47,"phone":48,"phoneExt":11,"email":49},"US Medical Information","CONTACT","888-275-7376","eMediUSA@emdserono.com",{"name":51,"role":47,"phone":52,"phoneExt":11,"email":53},"Communication Center","+49 6151 72 5200","service@emdgroup.com",[55,69,79,89,99,109,118,130],{"facility":56,"status":57,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":11},"Illinois CancerCare PC","RECRUITING","Peoria","Illinois","61615-7822","United States","US",{"type":64,"coordinates":65},"Point",[66,67],-89.58899,40.69365,{"lat":67,"lon":66},{"facility":70,"status":57,"city":71,"state":72,"zip":73,"country":61,"countryCode":62,"cosmosGeoPoint":74,"geoPoint":78,"contacts":11},"Profound Research LLC at Cancer and Leukemia Center","Sterling Heights","Michigan","48098",{"type":64,"coordinates":75},[76,77],-83.0302,42.58031,{"lat":77,"lon":76},{"facility":80,"status":57,"city":81,"state":82,"zip":83,"country":61,"countryCode":62,"cosmosGeoPoint":84,"geoPoint":88,"contacts":11},"Missouri Cancer Associates - 150518964","Columbia","Missouri","65201",{"type":64,"coordinates":85},[86,87],-92.33407,38.95171,{"lat":87,"lon":86},{"facility":90,"status":57,"city":91,"state":92,"zip":93,"country":61,"countryCode":62,"cosmosGeoPoint":94,"geoPoint":98,"contacts":11},"SCRI Oncology Partners","Nashville","Tennessee","37203",{"type":64,"coordinates":95},[96,97],-86.78444,36.16589,{"lat":97,"lon":96},{"facility":100,"status":57,"city":101,"state":102,"zip":103,"country":61,"countryCode":62,"cosmosGeoPoint":104,"geoPoint":108,"contacts":11},"Texas Oncology DFW","Bedford","Texas","75246",{"type":64,"coordinates":105},[106,107],-97.14307,32.84402,{"lat":107,"lon":106},{"facility":110,"status":57,"city":111,"state":102,"zip":112,"country":61,"countryCode":62,"cosmosGeoPoint":113,"geoPoint":117,"contacts":11},"Texas Oncology- San Antonio","San Antonio","78240",{"type":64,"coordinates":114},[115,116],-98.49363,29.42412,{"lat":116,"lon":115},{"facility":119,"status":57,"city":120,"state":121,"zip":122,"country":123,"countryCode":124,"cosmosGeoPoint":125,"geoPoint":129,"contacts":11},"GenesisCare North Shore (Oncology)","St Leonards","New South Wales","2065","Australia","AU",{"type":64,"coordinates":126},[127,128],151.19836,-33.82344,{"lat":128,"lon":127},{"facility":131,"status":57,"city":132,"state":133,"zip":134,"country":123,"countryCode":124,"cosmosGeoPoint":135,"geoPoint":139,"contacts":11},"Icon Cancer Centre Chermside","Chermside","Queensland","4032",{"type":64,"coordinates":136},[137,138],153.03062,-27.38472,{"lat":138,"lon":137},{"type":141,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[143],{"name":144,"class":6},"Merck KGaA, Darmstadt, Germany","100635186","phase-3-a-study-of-precemtabart-tocentecan-with-or-without-bevacizumab-compared-to-trifluridinetipiracil-plus-bevacizumab-in-participants-with-previously-treated-metastatic-colorectal-cancer-proceade-crc-03-100635186",false,"NCT07549412","A Study of Precemtabart Tocentecan With or Without Bevacizumab Compared to Trifluridine\u002FTipiracil Plus Bevacizumab in Participants With Previously Treated Metastatic Colorectal Cancer (PROCEADE-CRC-03)","A Randomized, Open Label, 3-arm Phase 3 Study of Precemtabart Tocentecan With or Without Bevacizumab Compared to Trifluridine\u002FTipiracil Plus Bevacizumab in Participants With Previously Treated Metastatic Colorectal Cancer (PROCEADE-CRC-03)","Inclusion Criteria:\n\n* Participants with documented histopathological diagnosis of metastatic colorectal cancer, who were intolerant to, or whose disease was refractory to, or progressed after standard systemic therapies and no more than 2 previous systemic treatment regimens in the metastatic setting.\n* Participants must have received and progressed on no more than 2 previous systemic treatment regimens in the metastatic setting\n* Eastern Cooperative Oncology Group (ECOG) performance status less than equal to 1\n* Participants must be able to swallow oral tablets, and to comply with the study requirements for all scheduled evaluations\n* Other protocol defined inclusion criteria may apply\n\nExclusion Criteria:\n\n* If Adverse Events related to previous therapies have not recovered to less than Grade 1 by National Cancer Institute - Common Terminology Criteria for Adverse Events version 6.0\n* Participant has a history of additional malignancy within 3 years before randomization\n* Participants with known brain metastases\n* Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months prior to randomization\n* Participants with ileus of more than Grade 1, or chronic inflammatory bowel disease (example ulcerative colitis, Crohn's disease) and\u002For bowel obstruction, or participants with chronic gastrointestinal disorders that, in the Investigator's opinion, might significantly interfere with proper absorption of the study treatments\n* Other protocol defined exclusion criteria may apply","ALL","18 Years",{"count":155,"type":156},1020,"ESTIMATED","INTERVENTIONAL",[159],"PHASE3","This study aims to address the unmet medical need of participants with metastatic colorectal cancer (mCRC) who have previously been treated with irinotecan, oxaliplatin, a fluoropyrimidine, and bevacizumab, by demonstrating an overall survival prolongation with precemtabart tocentecan (Precem-TcT) as single agent or Precem-TcT in combination with bevacizumab compared to trifluoride\u002Ftipiracil (FTD-TPI) plus bevacizumab.",[162],"Metastatic Colorectal Cancer",[164,165,166,167,30],"CEACAM5","Antibody-drug conjugate","Exatecan","M9140","2026-06-15",{"date":170,"type":171},"2026-06-16","ACTUAL",{"date":173,"type":171},"2026-05-06",{"date":175,"type":156},"2029-10-16",{"name":42,"class":6},8]