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Also known as RO7198457 intravenous (IV)
RO7198457 · 1 trial · 2 indications
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...
RO7198457 is an investigational drug being studied for the treatment of colorectal cancer. It is currently in a Phase 2 clinical trial for patients with ctDNA-positive, resected Stage II (high risk) and Stage III colorectal cancer. The drug is being evaluated as a potential treatment option for these patient populations.
RO7198457 is being developed by BioNTech SE, a biotechnology company. BioNTech SE is publicly traded under the ticker symbol BNTX. The company is conducting clinical research to evaluate the safety and efficacy of this investigational drug in patients with colorectal cancer.
RO7198457 is currently in Phase 2 of clinical development. It is being studied in an active, not recruiting clinical trial for patients with ctDNA-positive, resected Stage II (high risk) and Stage III colorectal cancer. The drug is investigational and has not yet been approved by regulatory authorities.
RO7198457 is being evaluated in a Phase 2 clinical trial with the identifier NCT04486378. This trial is comparing the efficacy of RO7198457 versus watchful waiting in patients with ctDNA-positive, resected Stage II (high risk) and Stage III colorectal cancer. The trial is active but not recruiting, with an enrollment of 327 participants.
Yes, RO7198457 is also known as RO7198457 intravenous (IV). The intravenous formulation is the form being studied in the Phase 2 clinical trial for colorectal cancer. Both names refer to the same investigational drug being developed by BioNTech SE.