Clinical Trial

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

Active, Not Recruiting Phase 2
View on ClinicalTrials.gov →
Summary
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.
Protocol Amendment History 3 changes
notable Trial sites reduced: 90 -> 87 locations 2026-07-02
critical Trial status changed: Recruiting → Active, Not Recruiting 2026-05-15
notable Trial sites reduced: 121 -> 90 locations 2026-05-15
Trial Details
NCT Number NCT04486378
Lead Sponsor BioNTech SE
Collaborators: Genentech, Inc.
Conditions Colorectal Cancer Stage II, Colorectal Cancer Stage III
Enrollment 327 participants
Start Date 2021-03-08
Primary Completion 2026-11 (estimated)
Study Completion 2030-08 (estimated)
Updated on ClinicalTrials.gov 2026-07-15