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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
Sponsor: BioNTech SE
Summary
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.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
327
Start Date
2021-03-08
Completion Date
2030-08
Last Updated
2026-03-17
Healthy Volunteers
No
Interventions
RO7198457 intravenous (IV)
RO7198457 administered as an IV injection at protocol-specified intervals over 12 months.
Observational group (no intervention)
watchful waiting
Locations (121)
Mayo Clinic - Scottsdale
Scottsdale, Arizona, United States
John Muir Clinical Research Center
Concord, California, United States
The Oncology Institute of Hope and Innovation
Glendale, California, United States
Marin Cancer Care
Greenbrae, California, United States
St Joseph Hospital of Orange
Orange, California, United States
Sansum Clinic
Santa Barbara, California, United States
Rocky Mountain Cancer Centers - Denver Midtwon
Denver, Colorado, United States
Boca Raton Regional Hospital
Boca Raton, Florida, United States
Florida Cancer Specialist South
Fort Myers, Florida, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
Florida Cancer Specialists
West Palm Beach, Florida, United States
Cancer Care Center of Decatur, Cancer Care Specialists of IL
Decatur, Illinois, United States
Indiana University Melvin and Bren Simon Comprehensive Cancer
Indianapolis, Indiana, United States
University of Kansas Cancer Center
Westwood, Kansas, United States
University of Louisville - James Graham Brown Cancer Center
Louisville, Kentucky, United States
Josephine Ford Cancer Center-Henry Ford Cancer Center
Detroit, Michigan, United States
Allina Health
Minneapolis, Minnesota, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
New York Oncology Hematology, P.C.
Albany, New York, United States
Weill Cornell Medical College
New York, New York, United States
New York - Presbyterian Hospital - Columbia University Medical center
New York, New York, United States
Oncology Hematology Care Clinical Trials
Cincinnati, Ohio, United States
Willamette Valley Cancer Institute and Research Center
Eugene, Oregon, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Hollings Cancer Center Medical University Of South Carolina
Charleston, South Carolina, United States
Sarah Cannon (Tennessee Oncology - Nashville)
Nashville, Tennessee, United States
Sarah Cannon Research Institute (SCRI) Oncology Partners
Nashville, Tennessee, United States
Texas Oncology, P.A. - Austin
Austin, Texas, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Texas Oncology-San Antonio Medical Center
San Antonio, Texas, United States
Texas Oncology - Northeast Texas
Tyler, Texas, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States
Benaroya Research Institute at Virginia Mason
Seattle, Washington, United States
University of Washington
Seattle, Washington, United States
MultiCare Institute for Research & Innovation
Spokane, Washington, United States
Northwest Cancer Specialists P.C.
Vancouver, Washington, United States
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States
Froedtert Hospital and Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Imeldaziekenhuis General Hospital
Bonheiden, Belgium
VZW Algemeen Ziekenhuis AZ Klina
Brasschaat, Belgium
Institut Jules Bordet
Brussels, Belgium
GHDC (Grand Hopital de Charleroi)
Charleroi, Belgium
AZ Groeninge
Kortrijk, Belgium
Centres Hospitaliers Jolimont
La Louvière, Belgium
Universitaire Ziekenhuizen Leuven
Leuven, Belgium
AZ Delta Roeselare
Roeselare, Belgium
GasthuisZusters Antwerpen - Sint-Augustinus
Wilrijk, Belgium
Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, Belgium
The Ottawa Hospital Cancer Centre
Ottawa, Canada
Princess Margaret Cancer Centre
Toronto, Canada
Charité - Universitätsmedizin Berlin
Berlin, Germany
Universitaetsklinikum St. Josef-Hospital Bochum
Bochum, Germany
Universitätsklinikum Bonn, Med. Klinik u. Poliklinik I
Bonn, Germany
Klinikum Esslingen GmbH
Esslingen am Neckar, Germany
Krankenhaus Nordwest GmbH - Institut Fuer Klinisch-Onkologische Forschung (IKF)
Frankfurt am Main, Germany
Klinikum der Johann Wolfgang Goethe-Universitaet Frankfurt
Frankfurt am Main, Germany
Studiengesellschaft BSF
Halle, Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany
Hämatologisch-Onkologische Praxis Eppendorf
Hamburg, Germany
Asklepios Klinik Altona
Hamburg, Germany
Medizinische Hochschule Hannover
Hanover, Germany
National Center for Tumor Diseases (NCT) Heidelberg
Heidelberg, Germany
SLK-Kliniken Heilbronn GmbH
Heilbronn, Germany
Staedtisches Krankenhaus Kiel gGmbH
Kiel, Germany
Universitaetsklinikum Leipzig AoeR
Leipzig, Germany
Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz KoeR
Mainz, Germany
Klinikum der Philipps-Universität Marburg
Marburg, Germany
LMU Klinikum (Campus Großhadern) Medizinische Klinik Universität München
München, Germany
Städtisches Klinikum München GmbH, Klinikum Neuperlach
München, Germany
OhO Ostholstein Onkologie
Oldenburg in Holstein, Germany
Prosper Hospital
Recklinghausen, Germany
Robert-Bosch-Krankenhaus - Centrum fuer Tumorerkrankungen
Stuttgart, Germany
Universitätsklinikum Ulm
Ulm, Germany
Universitätsklinikum Würzburg
Würzburg, Germany
Complejo Hospitalario Universitario A Coruna
A Coruña, Spain
Hospital Nuestra Senora de Sonsoles
Ávila, Spain
Hospital Universitari Germans Trias - ICO Badalona
Badalona, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Institut Clinic Hematolo/Oncologia- ICMHO, Hospital Clinic i Provincial de Barcelona
Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital Universitario Reina Sofia
Córdoba, Spain
Hospital General Universitario Gregorio Maranon
Madrid, Spain
Clinica Universidad Navarra
Madrid, Spain
Hospital Universitario Ramón y Cajal
Madrid, Spain
Hospital Clinico San Carlos
Madrid, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital Universitario HMN Sanchinarro, Centro Integral Oncologico Clara Campal (CIOCC)
Madrid, Spain
Hospital Universitario Puerta de Hierro de Majadahonda
Majadahonda, Spain
Hospital Regional Universitario Carlos Haya Malaga - Instituto de Investigacion Biomedica de Malaga
Málaga, Spain
Complejo Hospitalario de Orense
Ourense, Spain
Clinica Universitaria de Navarra
Pamplona, Spain
Complejo Hospitalario de Navarra (CHN)
Pamplona, Spain
Hospital Universitario Marques De Valdecilla
Santander, Spain
Complejo Hospitalario Universitario De Santiago De Compostela
Santiago de Compostela, Spain
Hospital Universitario Virgen del Rocio - Hospital de la Mujer
Seville, Spain
Consorcio Hospital General Valencia
Valencia, Spain
Complexo Hospitalario Universitario de Vigo (CHUVI)
Vigo, Spain
Hospital Universitario Miguel Servet
Zaragoza, Spain
Lunds Universitet - Medicinska Fakulteten (Lund University Faculty of Medicine)
Lund, Sweden
Sodersjukhuset, Onkologiska Kliniken
Stockholm, Sweden
Karolinska Universitetssjukhuset Solna
Stockholm, Sweden
The Clatterbridge Cancer Centre NHS Foundation Trust
Bebington, United Kingdom
Queen Elizabeth Hospital Birmingham-University Hospitals Birmingham NHS Foundation Trust
Birmingham, United Kingdom
Velindre NHS Trust, Velindre Cancer Centre
Cardiff, United Kingdom
Hull and East Yorkshire Hospitals NHS Trust - Castle Hill Hospital
Cottingham, United Kingdom
Dorset County Hospital NHS Foundation Trust - Dorset County Hospital
Dorchester, United Kingdom
Beatson West of Scotland Cancer Centre - Gartnavel Royal Hospital - NHS Greater Glasgow and Clyde
Glasgow, United Kingdom
St Bartholomew's Hospital-Barts Health NHS Trust
London, United Kingdom
University College London Hospitals NHS Foundation Trust
London, United Kingdom
Royal Free London NHS Foundation Trust
London, United Kingdom
Guy's and St Thomas' Hospital NHS Foundation Trust
London, United Kingdom
The Royal Marsden NHS Foundation Trust- Chelsea
London, United Kingdom
The Christie NHS Foundation Trust
Manchester, United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital
Newcastle upon Tyne, United Kingdom
Churchill Hospital - Oxford University Hospitals NHS Foundation Trust
Oxford, United Kingdom
Royal Preston Hospital - Lancashire Teaching Hospitals NHS Foundation Trust
Preston, United Kingdom
University Hospital Southampton NHS Foundation Trust - Southampton General Hospital
Southampton, United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton, United Kingdom
Torbay Hospital - South Devon Healthcare Nhs Foundation Trust, Lowes Bridge
Torquay, United Kingdom