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
This study is designed for patients who have recently undergone resection of their colon cancer and identified a high risk stage II or stage III cancer. ctDNA testing is done in the context of the trial with a Roche Molecular ctDNA assay.
Treatment Regimens
Upon completion of standard adjuvant therapy, patients are randomized to RO7198457 intravenous (i.v.) or observation. This is an open label study (patients are notified of the arm they are randomized into)
RO7198457 administered as an IV infusion at protocol-specified intervals over 12 months
Key Eligibility Criteria
- Patients must have Stage II/Stage III rectal cancer or Stage II (high risk)/Stage III colon cancer per AJCC 2017 that has been surgically totally resected (R0 confirmed by pathology report). Stage II (high risk) colon cancer is defined as Stage II disease with any of the following risk factors for recurrence:
- T4
- Grade ≥ 3.
- Clinical presentation with bowel obstruction or perforation.
- Histological signs of vascular, lymphatic or perineural invasion.
- < 12 nodes examined.
- Patients must have detectable ctDNA prior to start of adjuvant chemotherapy (AdCTx)• ctDNA assay must be performed through this study or study BNT000-001 ctDNA screening protocol.
See ClinicalTrials.gov for more details: