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

Trial status:Recruiting
Study Identifier:
BNT122-01
ClinicalTrials.gov Identifier:
NCT04486378
EudraCT Identifier:
2020-000451-12
Sponsor:
The sponsor of a clinical trial is the company, institution or individual that takes responsibility for initiating, managing, and/or financing a clinical investigation. BioNTech collaborates with other pharmaceutical companies or institutions (collaborators) to develop certain new medicines. In particular cases BioNTech's collaborators are leading specific clinical trials and are acting as sponsors accordingly.
BioNTech SE
Recruiting

Trial details

Medical Condition
  • Colorectal Cancer
    • Study Drug
  • Drug: RO7198457 intravenous (IV)
    • Phase
    Phase 2
    Sex
    Female & Male
    Age
    18+
    Estimated Trial Date
    Mar 2021 - Feb 2026

    Protocol 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.

    Trial locations

    Location
    Status
    Location
    Mayo Clinic - Scottsdale
    Scottsdale, Arizona, United States, 85259
    Status
    Recruiting
    Location
    John Muir Clinical Research Center
    Concord, California, United States, 94520
    Status
    Recruiting
    Location
    The Oncology Institute of Hope and Innovation
    Glendale, California, United States, 91204
    Status
    Recruiting
    Location
    Marin Cancer Care
    Greenbrae, California, United States, 94904
    Status
    Recruiting
    Location
    St Joseph Hospital of Orange
    Orange, California, United States, 92868
    Status
    Recruiting
    Location
    Sansum Clinic
    Santa Barbara, California, United States, 93105
    Status
    Recruiting