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)
Status: Recruiting
Location: See all (34) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Colorado
Rocky Mountain Cancer Centers, LLP- Aurora
RECRUITING
Lone Tree
Florida
Florida Cancer Specialists-Broadway
RECRUITING
Fort Myers
Florida Cancer Specialists - St. Petersburg Bayfront
RECRUITING
St. Petersburg
Florida Cancer Specialists East - FCS EAST - West Palm Beach
RECRUITING
West Palm Beach
Illinois
Illinois Cancer Specialists
RECRUITING
Arlington Heights
Illinois CancerCare PC
RECRUITING
Peoria
Springfield Clinic
RECRUITING
Springfield
Michigan
Profound Research LLC at Cancer and Leukemia Center
RECRUITING
Sterling Heights
Minnesota
Minnesota Oncology Hematology, P.A.
RECRUITING
Saint Louis Park
Missouri
Missouri Cancer Associates - 150518964
RECRUITING
Columbia
Tennessee
SCRI Oncology Partners
RECRUITING
Nashville
Texas
Texas Oncology, P.A. - Abilene - 300210366
RECRUITING
Abilene
Texas Oncology-South Austin
RECRUITING
Austin
Texas Oncology DFW
RECRUITING
Bedford
Texas Oncology- San Antonio
RECRUITING
San Antonio
Texas Oncology, P.A. - Tyler
RECRUITING
Tyler
Virginia
Virginia Oncology Associates
RECRUITING
Newport News
Blue Ridge Cancer Care - 300202915
RECRUITING
Roanoke
Other Locations
Australia
Flinders Medical Centre
RECRUITING
Bedford Park
Icon Cancer Centre Chermside
RECRUITING
Chermside
Mater Misericordiae Ltd - PARENT
RECRUITING
South Brisbane
GenesisCare North Shore (Oncology)
RECRUITING
St Leonards
Canada
University Health Network - Princess Margaret Cancer Centre
RECRUITING
Toronto
China
Sichuan Cancer Hospital
RECRUITING
Chengdu
Sun Yat-sen University Cancer Center
RECRUITING
Guangzhou
Japan
National Cancer Center Hospital
RECRUITING
Chūōku
Cancer Institute Hospital of JFCR
RECRUITING
Kōtoku
Kindai University Hospital
RECRUITING
Sakai-shi
Kanagawa Cancer Center - Dept of Gastroenterology
RECRUITING
Yokohama
Republic of Korea
Kyungpook National University Chilgok Hospital
RECRUITING
Daegu
Samsung Medical Center
RECRUITING
Seoul
Severance Hospital, Yonsei University Health System - Division of Infectious Diseases
RECRUITING
Seoul
The Catholic University of Korea, Seoul St. Maryâ
RECRUITING
Seoul
Taiwan
China Medical University Hospital
RECRUITING
Taichung
Contact Information
Primary
US Medical Information
eMediUSA@emdserono.com
888-275-7376
Backup
Communication Center
service@emdgroup.com
+49 6151 72 5200
Time Frame
Start Date:2026-05-06
Estimated Completion Date:2029-10-16
Participants
Target number of participants:1020
Treatments
Experimental: Arm 1: Precemtabart tocentecan (Precem-TcT) Monotherapy
Experimental: Arm 2: Precem-TcT plus Bevacizumab
Active_comparator: Arm 3: Trifluridine/Tipiracil (FTD-TPI) plus Bevacizumab