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Atezolizumab in Patients With MSI-h/MMR-D Stage II High Risk and Stage III Colorectal Cancer Ineligible for Oxaliplatin

Study acronym: ANTONIO
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Interventions: Atezolizumab (Drug) to Atezolizumab (Drug), IMM-101 (Drug) Study arms: 1 to 2v6 Show 1 more changeShow less
    • Study arms: 1 to 2
  2. Minor Trial status: Recruiting to Active, Not Recruiting Primary and study completion dates: Nov 15, 2026 to Apr 2027 · Site details revised · Study title expanded, about 5 wordsv5 Show 3 more changesShow less
    • Primary and study completion dates: Nov 15, 2026 to Apr 2027
    • Site details revised
    • Study title expanded, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  3. Notable Enrollment target: 120 to 80 Eligibility criteria shortened, about 8 words · Study arms: 2 to 1 · Study title shortened, about 2 wordsv4 Show 3 more changesShow less
    • Eligibility criteria shortened, about 8 words
    • Study arms: 2 to 1
    • Study title shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  4. Minor Re-verified, no change to tracked fieldsv3
  5. Notable Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Nov 15, 2021 to Dec 10, 2021 · Study description revisedv2 Show 3 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Nov 15, 2021 to Dec 10, 2021
    • Study description revised

    See this version in full on ClinicalTrials.gov ↗

  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The investigators hypothesize that atezolizumab will improve the prognosis of patients with stage III dMMR CRC ineligible for or refusing oxaliplatin-based adjuvant chemotherapy compared to SOC and that these could therefore be promising therapeutic options.
Trial Details
NCT Number NCT05118724
Lead Sponsor AIO-Studien-gGmbH
Collaborators: Roche Pharma AG, Immodulon Therapeutics Ltd
Conditions Colorectal Cancer
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov