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
NCT ID: NCT04486378
Last Updated: 2026-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
327 participants
INTERVENTIONAL
2021-03-08
2030-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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RO7198457
Participants will receive a recommended dose of RO7198457.
RO7198457 intravenous (IV)
RO7198457 administered as an IV injection at protocol-specified intervals over 12 months.
Observational Group
Observational group will undergo watchful waiting, which is the standard of care in this setting.
Observational group (no intervention)
watchful waiting
Biomarker Cohort
RO7198457 intravenous (IV)
RO7198457 administered as an IV injection at protocol-specified intervals over 12 months.
Exploratory Cohort
RO7198457 intravenous (IV)
RO7198457 administered as an IV injection at protocol-specified intervals over 12 months.
Colorectal Liver Metastasis (CLM) Cohort
RO7198457 intravenous (IV)
RO7198457 administered as an IV injection at protocol-specified intervals over 12 months.
Interventions
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RO7198457 intravenous (IV)
RO7198457 administered as an IV injection at protocol-specified intervals over 12 months.
Observational group (no intervention)
watchful waiting
Eligibility Criteria
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Inclusion Criteria
* Patients must have Stage II/Stage III rectal cancer or Stage II (high risk)/Stage III colon cancer per American Joint Committee on Cancer (AJCC) 2017 that has been surgically totally resected (R0 confirmed by pathology report). Stage II (high risk) colon cancer is defined as Stage II disease with any of the following risk factors for recurrence:
* T4
* Grade ≥ 3.
* Clinical presentation with bowel obstruction or perforation.
* Histological signs of vascular, lymphatic or perineural invasion.
* \< 12 nodes evaluated after surgery.
* For the CLM Cohort: patients must have metastatic colorectal cancer (mCRC) (Stage IV) with resected CLM (synchronous and metachronous CLM within 6 months of initial diagnosis) per AJCC 2017, after standard of care (SoC) primary resection and curative-intent hepatectomy (R0 confirmed by pathology report) with or without (neo-)adjuvant chemotherapy (prior to hepatectomy), and planned adjuvant chemotherapy.
* For the Biomarker Cohort: patients with tumors of the colon, including but not limited to, colon adenocarcinoma, carcinoid tumors (including goblet cell carcinoid/adenocarcinoma), and tumors of the appendix, whose tumors were surgically resected and are planned for adjuvant chemotherapy (per institutional standards), can be included.
* Patients must have detectable ctDNA prior to start of adjuvant chemotherapy (AdCTx) (except for the Biomarker Cohort).
* ctDNA assay must be performed through this trial or study BNT000-001 ctDNA screening protocol.
* Patients must have an Eastern Cooperative Oncology Group Performance Status of 0-1.
* Patients must have adequate hematologic, bone marrow and organ function as defined by the protocol.
* Adequate tumor material in formalin-fixed paraffin embedded blocks or as sectioned tissue (only upon approval by sponsor) must be available (as described in the laboratory manual). For the CLM Cohort: tumor material must come from primary resection for patients who undergo staged approach, or from available archival material from the previously untreated tumor biopsy from the primary.
* At least 5 tumor neoantigens identified in the provided tumor sample.
* The patient has started a standard of care AdCTx preferably within 8 weeks but no later than 10 weeks post-surgery and has completed at least 3 months of treatment of a 3- or a 6-month course of chemotherapy (including rest days). For the CLM Cohort: patient must have completed AdCTx with or without (neo-)adjuvant chemotherapy for up to 6 months in total or total intended amount determined by care providers per SoC. AdCTx must have started preferably within 8 weeks, but no later than 10 weeks, after hepatectomy. For the Biomarker Cohort: patient must have received at least one cycle of adjuvant chemotherapy per institutional standards.
Exclusion Criteria
* Diagnosed microsatellite instability high tumors.
* Prior therapy with any of the following:
* Neo-adjuvant (radio)chemotherapy prior to surgery.
* Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of trial treatment or anticipation of need for systemic immunosuppressive medication during trial treatment, with the exception of low dose steroids defined as 10 mg oral prednisone (or equivalent).
* Current or recent (within the 28 days prior to randomization) treatment with another investigational drug.
* Exception for the CLM Cohort: primary tumor must be resected and (neo-)adjuvant chemotherapy prior to curative-intent hepatectomy is accepted.
* Toxicities from previous anti-cancer therapies that have not resolved to baseline levels or to Grade 1 or less except for alopecia and peripheral neuropathy.
* Patients who developed metastatic disease during screening/receiving standard of care treatment (not applicable for the Exploratory Cohort or the Biomarker Cohort).
* Patients with known past or current malignancy other than inclusion diagnosis, except for:
* Cervical carcinoma of Stage 1B or less.
* Non-invasive basal cell or squamous cell skin carcinoma.
* Non-invasive, superficial bladder cancer.
* Prostate cancer with a current prostate-specific antigen level \< 0.1 ng/mL.
* Any curable cancer with a complete response of \> 2 years duration.
* Patients with known allergies, hypersensitivity, or intolerance to RO7198457 or its excipients.
* Patients who had major surgery (e.g., surgery requiring general anesthesia) within 4 weeks before screening, or will not have fully recovered from surgery, or have surgery planned during the time the patient are expected to participate in the trial.
* Patients with positive serology for hepatitis B indicative of active hepatitis B infection:
* Positive test for hepatitis B surface antigen (HBsAg) OR
* Negative test for HBsAg AND positive test for antibodies to hepatitis B core antigens (anti-HBc) AND positive test for hepatitis B virus (HBV) DNA.
* Serological markers indicative of vaccination (isolated antibodies to hepatitis B surface antigens \[anti-HBs\]) or resolved natural infection without viral load (anti-HBc with negative HBsAg and negative HBV DNA) are not exclusionary.
* Active Hepatitis C virus (HCV) infection; patients who have completed curative antiviral treatment with HCV viral load below the limit of quantification are allowed.
* Patients who have a history of human immunodeficiency virus (HIV) antibody positivity, or tests positive for HIV at screening.
* Patients who have had prior splenectomy.
18 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
BioNTech SE
INDUSTRY
Responsible Party
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Principal Investigators
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BioNTech Responsible Person
Role: STUDY_DIRECTOR
BioNTech SE
Locations
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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
Countries
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Central Contacts
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Other Identifiers
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2020-000451-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1250-5294
Identifier Type: OTHER
Identifier Source: secondary_id
2023-509516-28-00
Identifier Type: CTIS
Identifier Source: secondary_id
BNT122-01
Identifier Type: -
Identifier Source: org_study_id
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