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 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.

Trial Details

NCT ID
NCT04486378
Phase
PHASE2
Sponsor
BioNTech SE
Status
RECRUITING
Cancer Type
Colorectal Cancer
Interventions
  • RO7198457 intravenous (IV)
  • Observational group (no intervention)
Locations (sample)
  • Scottsdale, Arizona, United States|33.50921,-111.89903
  • Concord, California, United States|37.97798,-122.03107
  • Glendale, California, United States|34.14251,-118.25508
  • Greenbrae, California, United States|37.94854,-122.5247
  • Orange, California, United States|33.78779,-117.85311

Key Eligibility 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) 20…
  • Grade ≥ 3.
  • Clinical presentation with bowel obstruction or perforation.

For full eligibility, visit ClinicalTrials.gov.

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