A Multi-site, Open-label, Phase II, Randomized, Controlled Trial to Compare the Efficacy of RO7198457 Versus Watchful Waiting in Resected, Stage II (High Risk) and Stage III Colorectal Cancer Patients Who Are ctDNA Positive Following Resection
BioNTech SE
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.
Description
Patients will receive up to 15 doses of RO7198457 over the course of trial treatment.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 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. * \< 1…
Interventions
- DrugRO7198457 intravenous (IV)
RO7198457 administered as an IV injection at protocol-specified intervals over 12 months.
- OtherObservational group (no intervention)
watchful waiting
Locations (121)
- Mayo Clinic - ScottsdaleScottsdale, Arizona
- John Muir Clinical Research CenterConcord, California
- The Oncology Institute of Hope and InnovationGlendale, California
- Marin Cancer CareGreenbrae, California
- St Joseph Hospital of OrangeOrange, California
- Sansum ClinicSanta Barbara, California