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Neoadjuvant Immune Checkpoint Inhibition and Novel IO Combinations in Early-stage Colon Cancer

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

Record History

  1. Interventions modified Eligibility criteria expanded, about 18 words · Publications: details revised at 6 of 6 entries Show 2 more changesShow less
    • Eligibility criteria expanded, about 18 words
    • Publications: details revised at 6 of 6 entries
  2. Study description expanded, about 49 wordsv11 See this version in full on ClinicalTrials.gov ↗
  3. Primary and study completion dates: Dec 2024 to Mar 1, 2032 Primary endpoints: 2 to 3 · Enrollment target: 268 to 353 · Study description expanded, about 56 words · 1 morev10 Show 4 more changesShow less
    • Primary endpoints: 2 to 3
    • Enrollment target: 268 to 353
    • Study description expanded, about 56 words
    • Study arms: 5 to 7

    See this version in full on ClinicalTrials.gov ↗

  4. Study description expanded, about 28 wordsv9 See this version in full on ClinicalTrials.gov ↗
  5. Enrollment target: 60 to 268 Primary completion date: Jun 2021 to Dec 2024 · Primary endpoints: 1 to 2 · Completion date: Jan 2022 to Dec 2024 · 5 morev8 Show 8 more changesShow less
    • Primary completion date: Jun 2021 to Dec 2024
    • Primary endpoints: 1 to 2
    • Completion date: Jan 2022 to Dec 2024
    • Interventions: Celecoxib 200mg (Drug), Ipilimumab (Drug), Nivolumab (Drug) to BMS-986016 (Drug), BMS-986253 (Drug), Celecoxib 200mg (Drug), Ipilimumab (Drug), Nivolumab (Drug)
    • Eligibility criteria expanded, about 8 words
    • Study description expanded, about 138 words
    • Study arms: 2 to 5
    • Study title shortened, about 4 words

    See this version in full on ClinicalTrials.gov ↗

Show 6 earlier versionsHide 6 earlier versions
  1. Study sites: 5 to 6v7
  2. Study sites: 2 to 5v6
  3. Primary completion date: Jun 2019 to Jun 2021 Completion date: Jan 2020 to Jan 2022v5 Show 1 more changeShow less
    • Completion date: Jan 2020 to Jan 2022
  4. Study sites: 1 to 2v4
  5. Start date: Jan 2017 to Mar 29, 2017 Primary completion date: Jan 2019 to Jun 2019v3 Show 1 more changeShow less
    • Primary completion date: Jan 2019 to Jun 2019
  6. Trial status: Not Yet Recruiting to Recruiting Site details revisedv2 Show 1 more changeShow less
    • Site details revised
  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.
In this exploratory study, patients with stage 1-3 adenocarcinoma of the colon with no signs of distant metastases will be treated with short-term immunotherapy + novel IO combinations (i.e. anti-IL 8, COX2-inhibitors, anti-LAG3). This treatment will be given during the window period until surgical resection of the tumor. The duration of treatment will be in between approximately 6 and 12 weeks.
Trial Details
NCT Number NCT03026140
Lead Sponsor The Netherlands Cancer Institute
Collaborators: Bristol-Myers Squibb
Conditions Colon Carcinoma
Enrollment 353 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov