# 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

Source: https://onco.cc/trials/nct04486378/  
OnCo record `nct04486378` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 2 trial of RO7198457 intravenous (IV) in colorectal cancer, run by BioNTech SE, active and no longer recruiting.

## Summary

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 is a phase 2 interventional study registered as NCT04486378 by BioNTech SE, with 327 participants enrolled, started 2021-03-08 and due to reach its primary completion in 2026-11. Interventions recorded: RO7198457 intravenous (IV).

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-16
- Tags: pipeline; ctgov-ingest
- Registry id: NCT04486378
- Phase: 2
- Setting: 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
- Sponsor: BioNTech SE
- Enrolled: 327

## Sources

- ClinicalTrials.gov NCT04486378: https://clinicaltrials.gov/study/NCT04486378

## Connected records

- cancers: [Colorectal cancer](https://onco.cc/cancers/colorectal/)
- companies: [BioNTech](https://onco.cc/companies/biontech/), [Flatiron Health (Roche)](https://onco.cc/companies/flatiron-health/)

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JSON: https://onco.cc/api/v1/entities/nct04486378.json