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iRECIST Evaluation's Relevance for DCR in MMR/MSI Metastatic Colorectal Cancer Patients on Nivolumab and Ipilimumab

Study acronym: NIPICOL
StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Primary completion date: Feb 21, 2019 to Jan 10, 2020
    • Study completion date: Dec 2023 to Dec 2025
    v8
  2. Study title shortened, about 9 wordsv7
  3. Study completion date: Dec 2020 to Dec 2023v6
  4. Study completion date: Dec 2019 to Dec 2020v5
  5. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date changed from estimate of Dec 2018 to Feb 21, 2019
    • Site details revised at 8 of 8 sites
    v4
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  1. Start date changed from estimate of Dec 2017 to Dec 4, 2017v3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 8 of 8 sites
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a non-randomized study, open label phase II study. The purpose of this study is to evaluate disease control rate (DCR) by RECIST and iRECIST at 12 weeks. Evaluation of RECIST and iRECIST will be done in each center in order to choose the optimal therapy (Assessment by Investigators). A centralized evaluation of RECIST and iRECIST, will be organized in Saint-Antoine.
Trial Details
NCT Number NCT03350126
Lead Sponsor GERCOR - Multidisciplinary Oncology Cooperative Group
Collaborators: Bristol-Myers Squibb
Conditions
(from sponsor)		 Metastatic Cancer Colorectal
Related terms Colonic Neoplasms, Microsatellite Instability
Enrollment 57 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov