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

ClinicalTrials.gov ID: NCT04486378

Public ClinicalTrials.gov record NCT04486378. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced May 7, 2026, 12:12 PM EDT

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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 identification

NCT ID: NCT04486378
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 2
Lead sponsor: BioNTech SE; Industry
Enrollment: 327 participants

Conditions and interventions

Conditions

Interventions

Observational group (no intervention) Other
RO7198457 intravenous (IV) Drug

Other · Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Mar 7, 2021
Primary completion: Oct 31, 2026
Completion: Jul 31, 2030
Last update posted: Apr 14, 2026

2021 – 2030

United States locations

U.S. sites: 39
U.S. states: 20
U.S. cities: 36

Facility	City	State	ZIP	Site status
Mayo Clinic - Scottsdale	Scottsdale	Arizona	85259	Withdrawn
John Muir Clinical Research Center	Concord	California	94520	Active, not recruiting
The Oncology Institute of Hope and Innovation	Glendale	California	91204	Withdrawn
Marin Cancer Care	Greenbrae	California	94904	Active, not recruiting
St Joseph Hospital of Orange	Orange	California	92868	Withdrawn
Sansum Clinic	Santa Barbara	California	93105	Active, not recruiting
Rocky Mountain Cancer Centers - Denver Midtwon	Denver	Colorado	80218	Active, not recruiting
Boca Raton Regional Hospital	Boca Raton	Florida	33486	Withdrawn
Florida Cancer Specialist South	Fort Myers	Florida	33916	Withdrawn
Mayo Clinic Florida	Jacksonville	Florida	32224	Withdrawn
Florida Cancer Specialists	West Palm Beach	Florida	33401	Withdrawn
Cancer Care Center of Decatur, Cancer Care Specialists of IL	Decatur	Illinois	62526	Withdrawn
Indiana University Melvin and Bren Simon Comprehensive Cancer	Indianapolis	Indiana	46202	Active, not recruiting
University of Kansas Cancer Center	Westwood	Kansas	66205	Withdrawn
University of Louisville - James Graham Brown Cancer Center	Louisville	Kentucky	40202	Withdrawn
Josephine Ford Cancer Center-Henry Ford Cancer Center	Detroit	Michigan	48202	Withdrawn
Allina Health	Minneapolis	Minnesota	55407	Active, not recruiting
Mayo Clinic Rochester	Rochester	Minnesota	55905	Withdrawn
New York Oncology Hematology, P.C.	Albany	New York	12206	Withdrawn
Weill Cornell Medical College	New York	New York	10021	Withdrawn
New York - Presbyterian Hospital - Columbia University Medical center	New York	New York	10032	Withdrawn
Oncology Hematology Care Clinical Trials	Cincinnati	Ohio	45245	Active, not recruiting
Willamette Valley Cancer Institute and Research Center	Eugene	Oregon	97401	Withdrawn
Rhode Island Hospital	Providence	Rhode Island	02906	Active, not recruiting
Hollings Cancer Center Medical University Of South Carolina	Charleston	South Carolina	29425	Withdrawn
Sarah Cannon (Tennessee Oncology - Nashville)	Nashville	Tennessee	37203	Completed
Sarah Cannon Research Institute (SCRI) Oncology Partners	Nashville	Tennessee	37203	Withdrawn
Texas Oncology, P.A. - Austin	Austin	Texas	78705	Active, not recruiting
Texas Oncology-Baylor Charles A. Sammons Cancer Center	Dallas	Texas	75246	Active, not recruiting
The University of Texas MD Anderson Cancer Center	Houston	Texas	77030	Active, not recruiting
Texas Oncology-San Antonio Medical Center	San Antonio	Texas	78240	Active, not recruiting
Texas Oncology - Northeast Texas	Tyler	Texas	75702	Active, not recruiting
Virginia Cancer Specialists	Fairfax	Virginia	22031	Active, not recruiting
Benaroya Research Institute at Virginia Mason	Seattle	Washington	98101	Withdrawn
University of Washington	Seattle	Washington	98109	Active, not recruiting
MultiCare Institute for Research & Innovation	Spokane	Washington	99218	Withdrawn
Northwest Cancer Specialists P.C.	Vancouver	Washington	98684	Active, not recruiting
University of Wisconsin Carbone Cancer Center	Madison	Wisconsin	53792	Active, not recruiting
Froedtert Hospital and Medical College of Wisconsin	Milwaukee	Wisconsin	53226	Withdrawn

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 82 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT04486378, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Apr 14, 2026 · Synced May 7, 2026

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The complete protocol, eligibility criteria, and contact information for NCT04486378 live on ClinicalTrials.gov.

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