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

PHASE2RecruitingINTERVENTIONAL
Enrollment

327

Participants

Timeline

Start Date

March 8, 2021

Primary Completion Date

November 30, 2026

Study Completion Date

August 31, 2030

Conditions
Colorectal Cancer Stage IIColorectal Cancer Stage III
Interventions
DRUG

RO7198457 intravenous (IV)

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

OTHER

Observational group (no intervention)

watchful waiting

Trial Locations (121)

1070

WITHDRAWN

Institut Jules Bordet, Brussels

1200

ACTIVE_NOT_RECRUITING

Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-Luc, Woluwe-Saint-Lambert

2610

ACTIVE_NOT_RECRUITING

GasthuisZusters Antwerpen - Sint-Augustinus, Wilrijk

2820

ACTIVE_NOT_RECRUITING

Imeldaziekenhuis General Hospital, Bonheiden

2930

ACTIVE_NOT_RECRUITING

VZW Algemeen Ziekenhuis AZ Klina, Brasschaat

3000

ACTIVE_NOT_RECRUITING

Universitaire Ziekenhuizen Leuven, Leuven

6000

ACTIVE_NOT_RECRUITING

GHDC (Grand Hopital de Charleroi), Charleroi

7100

ACTIVE_NOT_RECRUITING

Centres Hospitaliers Jolimont, La Louvière

8036

RECRUITING

Institut Clinic Hematolo/Oncologia- ICMHO, Hospital Clinic i Provincial de Barcelona, Barcelona

8041

ACTIVE_NOT_RECRUITING

Hospital de la Santa Creu i Sant Pau, Barcelona

8500

ACTIVE_NOT_RECRUITING

AZ Groeninge, Kortrijk

8800

ACTIVE_NOT_RECRUITING

AZ Delta Roeselare, Roeselare

10021

WITHDRAWN

Weill Cornell Medical College, New York

10032

WITHDRAWN

New York - Presbyterian Hospital - Columbia University Medical center, New York

10117

ACTIVE_NOT_RECRUITING

Charité - Universitätsmedizin Berlin, Berlin

11883

ACTIVE_NOT_RECRUITING

Sodersjukhuset, Onkologiska Kliniken, Stockholm

12206

WITHDRAWN

New York Oncology Hematology, P.C., Albany

14004

ACTIVE_NOT_RECRUITING

Hospital Universitario Reina Sofia, Córdoba

15006

ACTIVE_NOT_RECRUITING

Complejo Hospitalario Universitario A Coruna, A Coruña

15706

ACTIVE_NOT_RECRUITING

Complejo Hospitalario Universitario De Santiago De Compostela, Santiago de Compostela

17176

ACTIVE_NOT_RECRUITING

Karolinska Universitetssjukhuset Solna, Stockholm

20246

ACTIVE_NOT_RECRUITING

Universitätsklinikum Hamburg-Eppendorf, Hamburg

20249

ACTIVE_NOT_RECRUITING

Hämatologisch-Onkologische Praxis Eppendorf, Hamburg

22031

RECRUITING

Virginia Cancer Specialists, Fairfax

22763

ACTIVE_NOT_RECRUITING

Asklepios Klinik Altona, Hamburg

23758

ACTIVE_NOT_RECRUITING

OhO Ostholstein Onkologie, Oldenburg in Holstein

24116

ACTIVE_NOT_RECRUITING

Staedtisches Krankenhaus Kiel gGmbH, Kiel

28007

ACTIVE_NOT_RECRUITING

Hospital General Universitario Gregorio Maranon, Madrid

28027

ACTIVE_NOT_RECRUITING

Clinica Universidad Navarra, Madrid

28034

ACTIVE_NOT_RECRUITING

Hospital Universitario Ramón y Cajal, Madrid

28040

ACTIVE_NOT_RECRUITING

Hospital Clinico San Carlos, Madrid

ACTIVE_NOT_RECRUITING

Hospital Universitario Fundacion Jimenez Diaz, Madrid

28046

ACTIVE_NOT_RECRUITING

Hospital Universitario La Paz, Madrid

28050

ACTIVE_NOT_RECRUITING

Hospital Universitario HMN Sanchinarro, Centro Integral Oncologico Clara Campal (CIOCC), Madrid

28222

ACTIVE_NOT_RECRUITING

Hospital Universitario Puerta de Hierro de Majadahonda, Majadahonda

29011

ACTIVE_NOT_RECRUITING

Hospital Regional Universitario Carlos Haya Malaga - Instituto de Investigacion Biomedica de Malaga, Málaga

29425

WITHDRAWN

Hollings Cancer Center Medical University Of South Carolina, Charleston

30625

ACTIVE_NOT_RECRUITING

Medizinische Hochschule Hannover, Hanover

31008

ACTIVE_NOT_RECRUITING

Clinica Universitaria de Navarra, Pamplona

ACTIVE_NOT_RECRUITING

Complejo Hospitalario de Navarra (CHN), Pamplona

32005

ACTIVE_NOT_RECRUITING

Complejo Hospitalario de Orense, Ourense

32224

WITHDRAWN

Mayo Clinic Florida, Jacksonville

33401

WITHDRAWN

Florida Cancer Specialists, West Palm Beach

33486

WITHDRAWN

Boca Raton Regional Hospital, Boca Raton

33916

WITHDRAWN

Florida Cancer Specialist South, Fort Myers

35043

ACTIVE_NOT_RECRUITING

Klinikum der Philipps-Universität Marburg, Marburg

36312

ACTIVE_NOT_RECRUITING

Complexo Hospitalario Universitario de Vigo (CHUVI), Vigo

37203

RECRUITING

Sarah Cannon (Tennessee Oncology - Nashville, Nashville

RECRUITING

Sarah Cannon Research Institute (SCRI) Oncology Partners, Nashville

39008

ACTIVE_NOT_RECRUITING

Hospital Universitario Marques De Valdecilla, Santander

40202

WITHDRAWN

University of Louisville - James Graham Brown Cancer Center, Louisville

41013

ACTIVE_NOT_RECRUITING

Hospital Universitario Virgen del Rocio - Hospital de la Mujer, Seville

44791

ACTIVE_NOT_RECRUITING

Universitaetsklinikum St. Josef-Hospital Bochum, Bochum

45245

RECRUITING

Oncology Hematology Care Clinical Trials, Cincinnati

45659

ACTIVE_NOT_RECRUITING

Prosper Hospital, Recklinghausen

46014

ACTIVE_NOT_RECRUITING

Consorcio Hospital General Valencia, Valencia

46202

RECRUITING

Indiana University Melvin and Bren Simon Comprehensive Cancer, Indianapolis

48202

WITHDRAWN

Josephine Ford Cancer Center-Henry Ford Cancer Center, Detroit

50009

ACTIVE_NOT_RECRUITING

Hospital Universitario Miguel Servet, Zaragoza

53105

ACTIVE_NOT_RECRUITING

Universitätsklinikum Bonn, Med. Klinik u. Poliklinik I, Bonn

53226

WITHDRAWN

Froedtert Hospital and Medical College of Wisconsin, Milwaukee

53792

RECRUITING

University of Wisconsin Carbone Cancer Center, Madison

55131

ACTIVE_NOT_RECRUITING

Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz KoeR, Mainz

55407

RECRUITING

Allina Health, Minneapolis

55905

WITHDRAWN

Mayo Clinic Rochester, Rochester

60488

ACTIVE_NOT_RECRUITING

Krankenhaus Nordwest GmbH - Institut Fuer Klinisch-Onkologische Forschung (IKF), Frankfurt am Main

60590

ACTIVE_NOT_RECRUITING

Klinikum der Johann Wolfgang Goethe-Universitaet Frankfurt, Frankfurt am Main

62526

RECRUITING

Cancer Care Center of Decatur, Cancer Care Specialists of IL, Decatur

66205

WITHDRAWN

University of Kansas Cancer Center, Westwood

69120

ACTIVE_NOT_RECRUITING

National Center for Tumor Diseases (NCT) Heidelberg, Heidelberg

70376

ACTIVE_NOT_RECRUITING

Robert-Bosch-Krankenhaus - Centrum fuer Tumorerkrankungen, Stuttgart

73730

ACTIVE_NOT_RECRUITING

Klinikum Esslingen GmbH, Esslingen am Neckar

74078

ACTIVE_NOT_RECRUITING

SLK-Kliniken Heilbronn GmbH, Heilbronn

75246

RECRUITING

Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas

75702

RECRUITING

Texas Oncology - Northeast Texas, Tyler

77030

RECRUITING

The University of Texas MD Anderson Cancer Center, Houston

78240

RECRUITING

Texas Oncology-San Antonio Medical Center, San Antonio

78705

RECRUITING

Texas Oncology, P.A. - Austin, Austin

80218

RECRUITING

Rocky Mountain Cancer Centers - Denver Midtwon, Denver

81377

ACTIVE_NOT_RECRUITING

LMU Klinikum (Campus Großhadern) Medizinische Klinik Universität München, München

81737

ACTIVE_NOT_RECRUITING

Städtisches Klinikum München GmbH, Klinikum Neuperlach, München

85259

WITHDRAWN

Mayo Clinic - Scottsdale, Scottsdale

89081

ACTIVE_NOT_RECRUITING

Universitätsklinikum Ulm, Ulm

91204

WITHDRAWN

The Oncology Institute of Hope and Innovation, Glendale

92868

WITHDRAWN

St Joseph Hospital of Orange, Orange

93105

RECRUITING

Sansum Clinic, Santa Barbara

94520

RECRUITING

John Muir Clinical Research Center, Concord

94904

RECRUITING

Marin Cancer Care, Greenbrae

97080

ACTIVE_NOT_RECRUITING

Universitätsklinikum Würzburg, Würzburg

97401

WITHDRAWN

Willamette Valley Cancer Institute and Research Center, Eugene

98101

RECRUITING

Benaroya Research Institute at Virginia Mason, Seattle

98109

RECRUITING

University of Washington, Seattle

98684

RECRUITING

Northwest Cancer Specialists P.C., Vancouver

99218

WITHDRAWN

MultiCare Institute for Research & Innovation, Spokane

02906

RECRUITING

Rhode Island Hospital, Providence

K1H 8M2

ACTIVE_NOT_RECRUITING

The Ottawa Hospital Cancer Centre, Ottawa

M5G 1X6

ACTIVE_NOT_RECRUITING

Princess Margaret Cancer Centre, Toronto

06108

ACTIVE_NOT_RECRUITING

Studiengesellschaft BSF, Halle

04103

ACTIVE_NOT_RECRUITING

Universitaetsklinikum Leipzig AoeR, Leipzig

05004

ACTIVE_NOT_RECRUITING

Hospital Nuestra Senora de Sonsoles, Ávila

08916

ACTIVE_NOT_RECRUITING

Hospital Universitari Germans Trias - ICO Badalona, Badalona

08035

RECRUITING

Hospital Universitari Vall d'Hebron, Barcelona

221 00

ACTIVE_NOT_RECRUITING

Lunds Universitet - Medicinska Fakulteten (Lund University Faculty of Medicine), Lund

CH63 4JY

RECRUITING

The Clatterbridge Cancer Centre NHS Foundation Trust, Bebington

B15 2GW

RECRUITING

Queen Elizabeth Hospital Birmingham-University Hospitals Birmingham NHS Foundation Trust, Birmingham

CF14 2TL

RECRUITING

Velindre NHS Trust, Velindre Cancer Centre, Cardiff

HU16 5JQ

RECRUITING

Hull and East Yorkshire Hospitals NHS Trust - Castle Hill Hospital, Cottingham

DT1 2JY

ACTIVE_NOT_RECRUITING

Dorset County Hospital NHS Foundation Trust - Dorset County Hospital, Dorchester

G12 0XH

RECRUITING

Beatson West of Scotland Cancer Centre - Gartnavel Royal Hospital - NHS Greater Glasgow and Clyde, Glasgow

EC1A 7BE

RECRUITING

St Bartholomew's Hospital-Barts Health NHS Trust, London

NW2 1PG

RECRUITING

University College London Hospitals NHS Foundation Trust, London

NW3 2QG

RECRUITING

Royal Free London NHS Foundation Trust, London

SE1 7EH

RECRUITING

Guy's and St Thomas' Hospital NHS Foundation Trust, London

SW3 6JJ

RECRUITING

The Royal Marsden NHS Foundation Trust- Chelsea, London

M20 4BX

ACTIVE_NOT_RECRUITING

The Christie NHS Foundation Trust, Manchester

NE7 7DN

RECRUITING

The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital, Newcastle upon Tyne

OX3 7LE

RECRUITING

Churchill Hospital - Oxford University Hospitals NHS Foundation Trust, Oxford

PR2 9HT

RECRUITING

Royal Preston Hospital - Lancashire Teaching Hospitals NHS Foundation Trust, Preston

SO16 6YD

RECRUITING

University Hospital Southampton NHS Foundation Trust - Southampton General Hospital, Southampton

SM25NG

RECRUITING

The Royal Marsden NHS Foundation Trust, Sutton

TQ2 7AA

RECRUITING

Torbay Hospital - South Devon Healthcare Nhs Foundation Trust, Lowes Bridge, Torquay

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Genentech, Inc.

INDUSTRY

lead

BioNTech SE

INDUSTRY

NCT04486378 - 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 | Biotech Hunter | Biotech Hunter