Spots Global Cancer Trial Database for 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
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Trial Identification
Brief Title: 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
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
Study ID: NCT04486378
Study Description
Brief 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.
Detailed Description: Patients will receive up to 15 doses of RO7198457 over the course of trial treatment.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
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
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
Mayo Clinic Rochester, Rochester, 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, Brussel, , Belgium
GHDC (Grand Hopital de Charleroi), Charleroi, , Belgium
AZ Groeninge, Kortrijk, , Belgium
Centres Hospitaliers Jolimont, La Louviere, , 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
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, , 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, Hannover, , 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 Coruna, , Spain
Hospital Nuestra Senora de Sonsoles, Avila, , 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, Cordoba, , 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, Orense, , 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, Sevilla, , 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
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
Royal Preston Hospital - Lancashire Teaching Hospitals NHS Foundation Trust, Preston, , United Kingdom
The Royal Marsden NHS Foundation Trust, Sutton, , United Kingdom
Torbay Hospital - South Devon Healthcare Nhs Foundation Trust, Lowes Bridge, Torquay, , United Kingdom
Contact Details
Name: BioNTech Responsible Person
Affiliation: BioNTech SE
Role: STUDY_DIRECTOR
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