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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 Oct 20, 2026, 2:23 PM 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 8, 2021 (Actual)
Primary completion
Nov 2026 (Estimated)
Completion
Nov 2026 (Estimated)
Last update posted
Oct 7, 2026

2021 – 2026

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 Oct 7, 2026 · Synced Oct 20, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04486378 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →