Title
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

Description
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.

Objective
Primary objective - To demonstrate superiority of RO7198457 compared to watchful waiting in terms of DFS (i.e., prolonged DFS time) in chemotherapy pretreated patients.

Secondary objectives
-To assess the efficacy of RO7198457 compared to watchful waiting in terms of RFS, TTR, TTF, and OS.
-To assess anti-tumor efficacy.
-To assess the safety and tolerability of RO7198457.

Treatment Experimental: RO7198457
Participants will receive a recommended dose of RO7198457.

Observational Group
Observational group will undergo watchful waiting, which is the standard of care in this setting.

Experimental: Biomarker Cohort
15 patients

Experimental: Exploratory Cohort
20 patients

Key Eligibility For full study eligibility, see this study's ClinicalTrials.gov record.

Applicable Disease Sites
Colon and Rectum

Participating Institutions
UW Health Eastpark Medical Center; UW Health University Hospital