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Neoadjuvant Immune Checkpoint Inhibition and Novel IO Combinations in Early-stage Colon Cancer (Amended Protocol of: Nivolumab, Ipilimumab and COX2-inhibition in Early Stage Colon Cancer: an Unbiased Approach for Signals of Sensitivity: The NICHE TRIAL)

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Trial Profile

Neoadjuvant Immune Checkpoint Inhibition and Novel IO Combinations in Early-stage Colon Cancer (Amended Protocol of: Nivolumab, Ipilimumab and COX2-inhibition in Early Stage Colon Cancer: an Unbiased Approach for Signals of Sensitivity: The NICHE TRIAL)

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 23 Sep 2024

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At a glance

  • Drugs HuMax IL8 (Primary) ; Ipilimumab (Primary) ; Nivolumab (Primary) ; Relatlimab (Primary) ; Celecoxib
  • Indications Adenocarcinoma; Colon cancer
  • Focus Adverse reactions; Pharmacodynamics; Therapeutic Use
  • Acronyms NICHE
  • Most Recent Events

    • 16 Apr 2024 The study was amended in Nov 2022 to add cohort 5 and 6, both in which patients will receive nivolumab plus relatlimab (anti-LA G3).
    • 16 Apr 2024 According to ClinicalTrials.gov record, accrual for cohort 4 was reached in July 2023. In April 2024, accrual for cohort 6 was reached. Per April 2024 only cohort 5 is open for recruitment.
    • 24 Oct 2023 According to Results presented at the 48th European Society for Medical Oncology Congress, accrual is currently ongoing in stage 2, in which an additional 40 patients will be treated.

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