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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

NCT04486378 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 327

Last updated 2026-05-14

No results posted yet for this study

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.

Conditions

  • Colorectal Cancer Stage II
  • Colorectal Cancer Stage III

Interventions

DRUG

RO7198457 intravenous (IV)

RO7198457 administered as an IV injection at protocol-specified intervals over 12 months.

OTHER

Observational group (no intervention)

watchful waiting

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • BioNTech SE

    lead INDUSTRY

Principal Investigators

  • BioNTech Responsible Person · BioNTech SE

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-08
Primary Completion
2026-11-30
Completion
2030-08-31
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Canada
  • Germany
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04486378 on ClinicalTrials.gov