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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

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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

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 29 Aug 2024

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At a glance

  • Drugs Autogene cevumeran (Primary)
  • Indications Colon cancer; Colorectal cancer; Rectal cancer
  • Focus Biomarker; Therapeutic Use
  • Sponsors BioNTech

    • Most Recent Events

    • 05 Aug 2024 According to a BioNTech media release, preliminary data from the ongoing Phase 2 clinical trial (NCT04486378) in stage II (high risk) and III ctDNA+ adjuvant CRC is expected in late 2025 or 2026.
    • 05 Aug 2024 According to a BioNTech media release, immunogenicity data were presented from the biomarker cohort of the ongoing Phase 2 at the 2024 European Society for Medical Oncology Gastrointestinal Cancers Congress.
    • 21 May 2024 According to a BioNTech media release, Preliminary results correlating post-operative ctDNA status with disease-free survival in Stage II (high risk) / III Colorectal Cancer Patients will be presented at the at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois, from May 31 to June 4, 2024

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