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)
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)
5 other identifiers
interventional
1,020
15 countries
65
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2026
Typical duration for phase_3
65 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 16, 2026
CompletedFirst Posted
Study publicly available on registry
April 24, 2026
CompletedStudy Start
First participant enrolled
May 6, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 16, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 16, 2029
September 9, 2026
August 1, 2026
3.4 years
April 16, 2026
September 8, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Arm 1, 2 and 3: Overall Survival
Time from date of randomization to death, assessed approximately up to average of 19 months
Secondary Outcomes (9)
Arm 1 and Arm 2: Overall Survival
Time from date of randomization to death, assessed approximately up to average of 19 months
Progression Free Survival (PFS)
Time from randomization to the first occurrence of disease progression or death, whichever occurs first (assessed up to average of 19 months)
Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigator
Up to average of 19 months
Duration of Response as Assessed by Investigator
Time from first documentation of objective response to PD or death (assessed up to average of 19 months)
Number of Participants with Adverse Events (AEs) and Treatment Related Adverse Events
Up to average of 19 months
- +4 more secondary outcomes
Study Arms (3)
Arm 1: Precemtabart tocentecan (Precem-TcT) Monotherapy
EXPERIMENTALArm 2: Precem-TcT plus Bevacizumab
EXPERIMENTALArm 3: Trifluridine/Tipiracil (FTD-TPI) plus Bevacizumab
ACTIVE COMPARATORInterventions
Precem-TcT, administered, once every 3 weeks intravenously, on Day 1 of each 21-day cycle.
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.
FTD-TPI, tablet, administered orally twice daily, on Days 1 to 5 and Days 8 to 12 of each 28-day cycle.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (66)
Rocky Mountain Cancer Centers, LLP- Aurora
Lone Tree, Colorado, 80124, United States
Florida Cancer Specialists-Broadway
Fort Myers, Florida, 33901, United States
Florida Cancer Specialists - St. Petersburg Bayfront
St. Petersburg, Florida, 33701-4553, United States
Florida Cancer Specialists East - FCS EAST - West Palm Beach
West Palm Beach, Florida, 33401, United States
Illinois Cancer Specialists
Arlington Heights, Illinois, 60005, United States
Illinois CancerCare PC
Peoria, Illinois, 61615-7822, United States
Springfield Clinic
Springfield, Illinois, 62702, United States
Profound Research LLC at Cancer and Leukemia Center
Sterling Heights, Michigan, 48098, United States
Minnesota Oncology Hematology, P.A.
Saint Louis Park, Minnesota, 55416, United States
Missouri Cancer Associates - 150518964
Columbia, Missouri, 65201, United States
White Plains Hospital Medical and Wellness PRIME
White Plains, New York, 10601, United States
SCRI Oncology Partners
Nashville, Tennessee, 37203, United States
Texas Oncology, P.A. - Abilene - 300210366
Abilene, Texas, 79606, United States
Texas Oncology-South Austin
Austin, Texas, 78745, United States
Texas Oncology DFW
Bedford, Texas, 75246, United States
Texas Oncology- San Antonio
San Antonio, Texas, 78240, United States
Texas Oncology, P.A. - Tyler
Tyler, Texas, 75702, United States
Virginia Oncology Associates
Newport News, Virginia, 23606, United States
Blue Ridge Cancer Care - 300202915
Roanoke, Virginia, 24014-2419, United States
Instituto de Oncologia de Rosario
Rosario, Santa Fe Province, S2000KZE, Argentina
Investigaciones Clinicas Moleculares ICM
Ciudad Autonoma Buenos Aires, C1417DTB, Argentina
Centro Oncologico de Excelencia
San Juan, 5400, Argentina
Centro de Investigaciones Medicas Tucuman
San Miguel de Tucumán, T4000AXL, Argentina
GenesisCare North Shore (Oncology)
St Leonards, New South Wales, 2065, Australia
Icon Cancer Centre Chermside
Chermside, Queensland, 4032, Australia
Mater Misericordiae Ltd - PARENT
South Brisbane, Queensland, 4101, Australia
Flinders Medical Centre
Bedford Park, South Australia, 5042, Australia
LKH - Universitätsklinikum der PMU Salzburg - Innere Med III/Hämatologie und Onkologie
Salzburg, 5020, Austria
Cliniques Universitaires Saint-Luc - STL
Brussels, 1200, Belgium
Grand Hospital de Charleroi - PARENT
Charleroi, 6000, Belgium
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, K1H 8L6, Canada
University Health Network - Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
Guangxi Medical University Cancer Hospital
Nanning, Guangxi Zhuang, 530021, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430060, China
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029, China
Sichuan Cancer Hospital
Chengdu, Sichuan, 610041, China
The Second Affiliated Hospital of Zhejiang University School of Medicine - 300173725
Hangzhou, Zhejiang, 310000, China
Hopital Claude Huriez - CHU Lille - service d'oncologie medicale
Lille, Nord, 59037, France
CHU Saint Etienne - Hôpital Nord - Service de Gastro-Entérologie et Hépatologie
Saint Priest En Jarez, Pays de la Loire Region, 42270, France
Centre Leon Berard - Service d'Oncologie Medicale
Lyon, Rhone, 69008, France
Groupe Hospitalier Pitie-Salpetriere - Service Hépato-Gastro-Entérologie
Paris, 75013, France
Krankenhaus Nordwest GmbH - Neurologische Klinik
Frankfurt am Main, Hesse, 60488, Germany
The Chinese University of Hong Kong (CUHK) - Prince of Wales Hospital (PWH)
Hong Kong, 00000, Hong Kong
NHO Kyushu Cancer Center - 300175822
Fukuoka, Fukuoka, 811-1395, Japan
Kanagawa Cancer Center - Dept of Gastroenterology
Yokohama, Kanagawa, 241-8515, Japan
Kindai University Hospital
Sakai-shi, Osaka, 590-0197, Japan
Saitama Cancer Center - 300175812
Kitaadachi-gun, Saitama, 362-0806, Japan
National Cancer Center Hospital
Chūōku, Tokyo-To, 104-0045, Japan
Cancer Institute Hospital of JFCR
Kōtoku, Tokyo-To, 135-8550, Japan
SP ZOZ Szpital Uniwersytecki w Krakowie - Dept of Clinical Oncology and Oncology Clinic
Krakow, 31-501, Poland
National Cancer Center
Goyang-si, Gyeonggi-do, 10408, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
Kyungpook National University Chilgok Hospital
Daegu, Gyeongsangnam-do, 700-721, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Severance Hospital, Yonsei University Health System - Division of Infectious Diseases
Seoul, 03722, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
The Catholic University of Korea, Seoul St. Maryâ
Seoul, 06591, South Korea
Korea University Guro Hospital
Seoul, 08308, South Korea
Asan Medical Center
Seoul, 138-736, South Korea
Hospital Universitario Ramon y Cajal - Servicio de Oncologia
Madrid, 28034, Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807, Taiwan
China Medical University Hospital
Taichung, 40447, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Aberdeen Royal Infirmary - Dept of Oncology
Aberdeen, Grampian Region, AB25 2ZN, United Kingdom
The Christie Hospital - Dept of Oncology
Manchester, Great Manchester, M20 4BX, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Responsible
EMD Serono Research & Development Institute, Inc.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 16, 2026
First Posted
April 24, 2026
Study Start
May 6, 2026
Primary Completion (Estimated)
October 16, 2029
Study Completion (Estimated)
October 16, 2029
Last Updated
September 9, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
- Time Frame
- IPD from completed trials will be publicly available within 6 months after all of the following events: * Approval of a product/new indication by major authorities (FDA, EMA, PMDA if requested) with no pending submissions * Public results via primary manuscript or trial registry disclosure * Legal authority to share data * Privacy protections are in place If approval is not sought or development is globally discontinued, data will be publicly available within 18 months after global trial completion. Further information on how to request data can be found on our website bit.ly/IPD21
- Access Criteria
- Qualified researchers may propose access to IPD from sponsored trials via https://vivli.org/members/ourmembers/.
IPD supporting publicly available results will be evaluated for sharing.