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Active, not recruiting Phase 2 Interventional

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.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 6:26 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT04486378
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 2
Lead sponsor
BioNTech SE
Industry
Enrollment
327 participants

Conditions and interventions

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
Aug 27, 2026

2021 – 2030

United States locations

U.S. sites
15
U.S. states
10
U.S. cities
15
Facility City State ZIP Site status
Marin Cancer Care Greenbrae California 94904
Indiana University Melvin and Bren Simon Comprehensive Cancer Indianapolis Indiana 46202
Allina Health Minneapolis Minnesota 55407
Oncology Hematology Care Clinical Trials Cincinnati Ohio 45245
Rhode Island Hospital Providence Rhode Island 02906
Sarah Cannon (Tennessee Oncology - Nashville) Nashville Tennessee 37203
Texas Oncology, P.A. - Austin Austin Texas 78705
Texas Oncology-Baylor Charles A. Sammons Cancer Center Dallas Texas 75246
The University of Texas MD Anderson Cancer Center Houston Texas 77030
Texas Oncology-San Antonio Medical Center San Antonio Texas 78240
Texas Oncology - Northeast Texas Tyler Texas 75702
Virginia Cancer Specialists Fairfax Virginia 22031
University of Washington Seattle Washington 98109
Northwest Cancer Specialists P.C. Vancouver Washington 98684
University of Wisconsin Carbone Cancer Center Madison Wisconsin 53792

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 70 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 Aug 27, 2026 · Synced Sep 2, 2026

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Open the official record

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

View official ClinicalTrials.gov record →