NCT04486378

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 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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 327 (estimated)
• Sponsor: BioNTech SE · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Patients will receive up to 15 doses of RO7198457 over the course of trial treatment.

Conditions

• Colorectal Cancer Stage II
• Colorectal Cancer Stage III

Interventions

Type	Name	Description
DRUG	RO7198457 intravenous (IV)	RO7198457 administered as an IV injection at protocol-specified intervals over 12 months.
OTHER	Observational group (no intervention)	watchful waiting

Timeline

• Start date: 2021-03-08
• Primary completion: 2026-11-01
• Completion: 2030-08-01
• First posted: 2020-07-24
• Last updated: 2026-04-15

Locations

121 sites across 7 countries: United States, Belgium, Canada, Germany, Spain, Sweden, United Kingdom

Regulatory

• FDA-regulated drug study