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Two Combination Treatment Regimens of Nivolumab and Ipilimumab in Patients With dMMR and / or MSI mCRC.

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

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  1. Re-verified, no change to tracked fieldsv7
  2. Start date: Apr 13, 2021 to May 21, 2021
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 19 of 19 sites
    v6
  3. Primary completion date: Mar 2028 to Apr 2027
    • Study completion date: Mar 2028 to Apr 2028
    • Start date: Apr 1, 2021 to Apr 13, 2021
    • Site details revised at 11 of 19 sites
    v5
  4. Primary completion date: Mar 2023 to Mar 2028v4 Show 5 more changesShow less
    • Primary endpoints revised (2)
    • Interventions: Ipilimumab (Drug), Nivolumab (Drug), Nivolumab (Drug) to Nivolumab 240 mg + Ipilimumab (Drug), Nivolumab 480mg + Ipilimumab (Drug)
    • Secondary endpoints revised (9)
    • Study description expanded, about 150 words
    • Study title shortened, about 6 words
  5. Re-verified, no change to tracked fieldsv3
  6. Trial status: Not Yet Recruiting to Recruitingv2 Show 6 more changesShow less
    • Primary endpoints revised (2)
    • Start date changed from estimate of Mar 2021 to Apr 1, 2021
    • Eligibility criteria expanded, about 15 words
    • Secondary endpoints revised (9)
    • Site details revised at 19 of 19 sites
    • Study title shortened, about 6 words
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
NIPISAFE is open-label, phase II study to identify a combination scheme of nivolumab and ipilimumab with a high level of clinical activity, but with a lower toxicity in MSI/dMMR metastatic colorectal cancer patients.
Trial Details
NCT Number NCT04730544
Lead Sponsor GERCOR - Multidisciplinary Oncology Cooperative Group
Collaborators: Bristol-Myers Squibb
Conditions
(from sponsor)		 Colorectal Cancer Metastatic, MSI-H Colorectal Cancer
Enrollment 96 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov