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Pre-operative Trial for Breast Cancer With Nivolumab in Combination With Novel IO

Study acronym: BELLINI
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary endpoint revised Eligibility criteria expanded, about 53 words · Secondary endpoints revised (3)v13 Show 2 more changesShow less
    • Eligibility criteria expanded, about 53 words
    • Secondary endpoints revised (3)

    See this version in full on ClinicalTrials.gov ↗

  2. Primary completion date: Jan 7, 2025 to Jan 1, 2031 Completion date: Jan 7, 2027 to Jan 1, 2033v12 Show 1 more changeShow less
    • Completion date: Jan 7, 2027 to Jan 1, 2033
  3. Primary completion date: Jan 7, 2023 to Jan 7, 2025 Completion date: Jan 7, 2025 to Jan 7, 2027v11 Show 1 more changeShow less
    • Completion date: Jan 7, 2025 to Jan 7, 2027
  4. Re-verified, no change to tracked fieldsv10
  5. Eligibility criteria expanded, about 17 wordsv9 See this version in full on ClinicalTrials.gov ↗
Show 7 earlier versionsHide 7 earlier versions
  1. Re-verified, no change to tracked fieldsv8
  2. Interventions: Ipilimumab (Drug), Nivolumab (Drug) to Ipilimumab (Drug), Ipilimumab (Drug), Nivolumab (Drug) Study arms: 4 to 5 · Eligibility criteria expanded, about 5 wordsv7 Show 2 more changesShow less
    • Study arms: 4 to 5
    • Eligibility criteria expanded, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  3. Re-verified, no change to tracked fieldsv6
  4. Interventions: Doxorubicin (Drug), Nivolumab (Drug) to Ipilimumab (Drug), Nivolumab (Drug)v5
  5. Re-verified, no change to tracked fieldsv4
  6. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Mar 1, 2019 to Oct 4, 2019 · Site details revisedv3 Show 2 more changesShow less
    • Start date changed from estimate of Mar 1, 2019 to Oct 4, 2019
    • Site details revised
  7. Interventions: Nivolumab (Drug), Nivolumab and doxorubicin (Drug) to Doxorubicin (Drug), Nivolumab (Drug)v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
To determine whether short-term pre-operative nivolumab either as monotherapy or in combination with low dose doxorubicin or novel IO combinations can induce immune activation in early BC.
Trial Details
NCT Number NCT03815890
Lead Sponsor The Netherlands Cancer Institute
Collaborators: Bristol-Myers Squibb
Conditions Breast Cancer
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov