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A Study of Precemtabart Tocentecan With or Without Bevacizumab Compared to Trifluridine/Tipiracil Plus Bevacizumab in Participants With Previously Treated Metastatic Colorectal Cancer (PROCEADE-CRC-03)

NCT07549412 · EMD Serono
In plain English

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Official title
A Randomized, Open Label, 3-arm Phase 3 Study of Precemtabart Tocentecan With or Without Bevacizumab Compared to Trifluridine/Tipiracil Plus Bevacizumab in Participants With Previously Treated Metastatic Colorectal Cancer (PROCEADE-CRC-03)
About this study
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/tipiracil (FTD-TPI) plus bevacizumab.
Eligibility criteria
Inclusion Criteria: * 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. * Participants must have received and progressed on no more than 2 previous systemic treatment regimens in the metastatic setting * Eastern Cooperative Oncology Group (ECOG) performance status less than equal to 1 * Participants must be able to swallow oral tablets, and to comply with the study requirements for all scheduled evaluations * Other protocol defined inclusion criteria may apply Exclusion Criteria: * 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 * Participant has a history of additional malignancy within 3 years before randomization * Participants with known brain metastases * Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months prior to randomization * Participants with ileus of more than Grade 1, or chronic inflammatory bowel disease (example ulcerative colitis, Crohn's disease) and/or bowel obstruction, or participants with chronic gastrointestinal disorders that, in the Investigator's opinion, might significantly interfere with proper absorption of the study treatments * Other protocol defined exclusion criteria may apply
Study design
Enrollment target: 1020 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-05-06
Estimated completion: 2029-10-16
Last updated: 2026-09-09
Interventions
Drug: Precemtabart tocentecanDrug: BevacizumabDrug: Trifluridine/Tipiracil (FTD-TPI)
Primary outcomes
  • Arm 1, 2 and 3: Overall Survival (Time from date of randomization to death, assessed approximately up to average of 19 months)
Sponsor
EMD Serono Research & Development Institute, Inc. · industry
With: Merck KGaA, Darmstadt, Germany
Contacts & investigators
ContactUS Medical Information · contact · eMediUSA@emdserono.com · 888-275-7376
ContactCommunication Center · contact · service@emdgroup.com · +49 6151 72 5200
InvestigatorMedical Responsible · study_director, EMD Serono Research & Development Institute, Inc.
All locations (66)
Rocky Mountain Cancer Centers, LLP- AuroraRecruiting
Lone Tree, Colorado, United States
Florida Cancer Specialists-BroadwayRecruiting
Fort Myers, Florida, United States
Florida Cancer Specialists - St. Petersburg BayfrontRecruiting
St. Petersburg, Florida, United States
Florida Cancer Specialists East - FCS EAST - West Palm BeachRecruiting
West Palm Beach, Florida, United States
Illinois Cancer SpecialistsRecruiting
Arlington Heights, Illinois, United States
Illinois CancerCare PCRecruiting
Peoria, Illinois, United States
Springfield ClinicRecruiting
Springfield, Illinois, United States
Profound Research LLC at Cancer and Leukemia CenterRecruiting
Sterling Heights, Michigan, United States
Minnesota Oncology Hematology, P.A.Recruiting
Saint Louis Park, Minnesota, United States
Missouri Cancer Associates - 150518964Recruiting
Columbia, Missouri, United States
White Plains Hospital Medical and Wellness PRIMERecruiting
White Plains, New York, United States
SCRI Oncology PartnersRecruiting
Nashville, Tennessee, United States
Texas Oncology, P.A. - Abilene - 300210366Recruiting
Abilene, Texas, United States
Texas Oncology-South AustinRecruiting
Austin, Texas, United States
Texas Oncology DFWRecruiting
Bedford, Texas, United States
Texas Oncology- San AntonioRecruiting
San Antonio, Texas, United States
Texas Oncology, P.A. - TylerRecruiting
Tyler, Texas, United States
Virginia Oncology AssociatesRecruiting
Newport News, Virginia, United States
Blue Ridge Cancer Care - 300202915Recruiting
Roanoke, Virginia, United States
Instituto de Oncologia de RosarioRecruiting
Rosario, Santa Fe Province, Argentina
Investigaciones Clinicas Moleculares ICMRecruiting
Ciudad Autonoma Buenos Aires, Argentina
Centro Oncologico de ExcelenciaRecruiting
San Juan, Argentina
Centro de Investigaciones Medicas TucumanRecruiting
San Miguel de Tucumán, Argentina
GenesisCare North Shore (Oncology)Recruiting
St Leonards, New South Wales, Australia
Icon Cancer Centre ChermsideRecruiting
Chermside, Queensland, Australia
Mater Misericordiae Ltd - PARENTRecruiting
South Brisbane, Queensland, Australia
Flinders Medical CentreRecruiting
Bedford Park, South Australia, Australia
LKH - Universitätsklinikum der PMU Salzburg - Innere Med III/Hämatologie und OnkologieRecruiting
Salzburg, Austria
Cliniques Universitaires Saint-Luc - STLRecruiting
Brussels, Belgium
Grand Hospital de Charleroi - PARENTRecruiting
Charleroi, Belgium
The Ottawa Hospital Cancer CentreRecruiting
Ottawa, Ontario, Canada
University Health Network - Princess Margaret Cancer CentreRecruiting
Toronto, Ontario, Canada
Sun Yat-sen University Cancer CenterRecruiting
Guangzhou, Guangdong, China
Guangxi Medical University Cancer HospitalRecruiting
Nanning, Guangxi Zhuang, China
Union Hospital Tongji Medical College Huazhong University of Science and TechnologyRecruiting
Wuhan, Hubei, China
Jiangsu Province HospitalRecruiting
Nanjing, Jiangsu, China
Sichuan Cancer HospitalRecruiting
Chengdu, Sichuan, China
The Second Affiliated Hospital of Zhejiang University School of Medicine - 300173725Recruiting
Hangzhou, Zhejiang, China
Hopital Claude Huriez - CHU Lille - service d'oncologie medicaleRecruiting
Lille, Nord, France
CHU Saint Etienne - Hôpital Nord - Service de Gastro-Entérologie et HépatologieRecruiting
Saint Priest En Jarez, Pays de la Loire Region, France
Centre Leon Berard - Service d'Oncologie MedicaleRecruiting
Lyon, Rhone, France
Groupe Hospitalier Pitie-Salpetriere - Service Hépato-Gastro-EntérologieRecruiting
Paris, France
Krankenhaus Nordwest GmbH - Neurologische KlinikRecruiting
Frankfurt am Main, Hesse, Germany
The Chinese University of Hong Kong (CUHK) - Prince of Wales Hospital (PWH)Recruiting
Hong Kong, Hong Kong
NHO Kyushu Cancer Center - 300175822Recruiting
Fukuoka, Fukuoka, Japan
Kanagawa Cancer Center - Dept of GastroenterologyRecruiting
Yokohama, Kanagawa, Japan
Kindai University HospitalRecruiting
Sakai-shi, Osaka, Japan
Saitama Cancer Center - 300175812Recruiting
Kitaadachi-gun, Saitama, Japan
National Cancer Center HospitalRecruiting
Chūōku, Tokyo-To, Japan
Cancer Institute Hospital of JFCRRecruiting
Kōtoku, Tokyo-To, Japan
SP ZOZ Szpital Uniwersytecki w Krakowie - Dept of Clinical Oncology and Oncology ClinicRecruiting
Krakow, Poland
National Cancer CenterRecruiting
Goyang-si, Gyeonggi-do, South Korea
Seoul National University Bundang HospitalRecruiting
Seongnam-si, Gyeonggi-do, South Korea
Kyungpook National University Chilgok HospitalRecruiting
Daegu, Gyeongsangnam-do, South Korea
Seoul National University HospitalRecruiting
Seoul, South Korea
Severance Hospital, Yonsei University Health System - Division of Infectious DiseasesRecruiting
Seoul, South Korea
Samsung Medical CenterRecruiting
Seoul, South Korea
The Catholic University of Korea, Seoul St. MaryâRecruiting
Seoul, South Korea
Korea University Guro HospitalRecruiting
Seoul, South Korea
Asan Medical CenterRecruiting
Seoul, South Korea
Hospital Universitario Ramon y Cajal - Servicio de OncologiaRecruiting
Madrid, Spain
Kaohsiung Medical University Chung-Ho Memorial HospitalRecruiting
Kaohsiung City, Taiwan
China Medical University HospitalRecruiting
Taichung, Taiwan
Taipei Veterans General HospitalRecruiting
Taipei, Taiwan
Aberdeen Royal Infirmary - Dept of OncologyRecruiting
Aberdeen, Grampian Region, United Kingdom
The Christie Hospital - Dept of OncologyRecruiting
Manchester, Great Manchester, United Kingdom