Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | PHASE2 | ACTIVE NOT_RECRUITING | 327 | — | — | Mar 8, 2021 | Aug 1, 2030 | May 14, 2026 | 90 | United States, Belgium +5 |
DFS defined as the time from randomization to occurrence of any of the following events, whichever occurs first: * Locoregional recurrence or distant metastases as determined by an independent central radiology assessment. * Occurrence of second primary (same or other) cancer as determined by an independent central radiology assessment. * Death from any cause. * Loss to follow-up is censored.
| Arm | Type | Description |
|---|---|---|
| RO7198457 | EXPERIMENTAL | Participants will receive a recommended dose of RO7198457. |
| Observational Group | OTHER | Observational group will undergo watchful waiting, which is the standard of care in this setting. |
| Biomarker Cohort | EXPERIMENTAL | - |
| Exploratory Cohort | EXPERIMENTAL | - |
| Colorectal Liver Metastasis (CLM) Cohort | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| RO7198457 intravenous (IV) | DRUG | RO7198457 administered as an IV injection at protocol-specified intervals over 12 months. |
| Observational group (no intervention) | OTHER | watchful waiting |
Inclusion Criteria: * Patients must be a man or woman of at least 18 years of age. * Patients must have Stage II/Stage III rectal cancer or Stage II (high risk)/Stage III colon cancer per American Joint Committee on Cancer (AJCC) 2017 that has been surgically totally resected (R0 confirmed by patho...