RecruitingPhase 2NCT04486378

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

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

Sponsor

BioNTech SE

Enrollment

327 participants

Start Date

Mar 8, 2021

Study Type

INTERVENTIONAL

Conditions

Colorectal Cancer Stage III Colorectal Cancer Stage II

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a personalized mRNA cancer vaccine called RO7198457 in patients with colorectal cancer who have had surgery to remove the tumor but have detectable tumor DNA in the blood — a sign the cancer may return. It compares the vaccine to watchful waiting to see if vaccination can prevent relapse. **You may be eligible if...** - You are 18 or older and have had stage II (high-risk) or stage III colorectal cancer surgically removed (R0 resection confirmed) - Your blood test shows circulating tumor DNA (ctDNA) after surgery - You have completed standard adjuvant chemotherapy if recommended - You have no evidence of cancer on imaging after surgery **You may NOT be eligible if...** - Your cancer was not fully removed by surgery - You have active cancer elsewhere - You have a compromised immune system or are on immunosuppressant drugs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRO7198457 intravenous (IV)

RO7198457 administered as an IV injection at protocol-specified intervals over 12 months.

OTHERObservational 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

View Full Details on ClinicalTrials.gov

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NCT04486378

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