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Contact Information:

BioNTech clinical trials patient information +49 6131 9084
patients@biontech.de


Study Location:

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Be Part of Research - Trial Details - 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

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

Recruiting

Open to: ALL

Age: 18.0 - N/A

Medical Conditions

Colorectal Cancer Stage II
Colorectal Cancer Stage III


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Mar 2021 Nov 2026

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : RO7198457 administered as an IV injection at protocol-specified intervals over 12 months.

Intervention Arm Group : Biomarker Cohort;Colorectal Liver Metastasis (CLM) Cohort;Exploratory Cohort;RO7198457;

Intervention Type : OTHER
Intervention Description : watchful waiting

Intervention Arm Group : Observational Group;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

BioNTech clinical trials patient information +49 6131 9084
patients@biontech.de



The study is sponsored by BioNTech SE and is in collaboration with Genentech, Inc..




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Read full details for Trial ID: NCT04486378
Last updated 14 April 2026

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