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Neoadjuvant Nivolumab With CCR2/5-inhibitor or Anti-IL-8) for Non-small Cell Lung Cancer (NSCLC) or Hepatocellular Carcinoma (HCC)

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Sponsor refiled this as active, not recruiting (was completed)
    • Study completion date: Aug 24, 2025 to Jul 13, 2028
    • Eligibility criteria expanded, about 23 words
    • Secondary endpoints: details revised at 3 of 5 entries
  2. Trial status: Active, Not Recruiting to Completed
    • Primary completion date changed from estimate of Dec 31, 2025 to Aug 24, 2023
    • Study completion date changed from estimate of Dec 31, 2025 to Aug 24, 2025
    v12
  3. Primary and study completion dates: Nov 16, 2023 to Dec 31, 2025
    • Trial status: Completed to Active, Not Recruiting
    v11
  4. Trial status: Active, Not Recruiting to Completed
    • Enrollment target: 36 to 48
    • Primary completion date: Aug 31, 2023 to Nov 16, 2023
    • Study completion date changed from estimate of Sep 1, 2024 to Nov 16, 2023
    v10
  5. Trial status: Recruiting to Active, Not Recruitingv9 Show 5 more changesShow less
    • Enrollment target: estimated 50 to confirmed 36
    • Primary completion date changed from estimate of Oct 2024 to Aug 31, 2023
    • Study completion date: Oct 2024 to Sep 1, 2024
    • Start date: Mar 19, 2020 to Mar 5, 2020
    • Site details revised
Show 7 earlier versionsHide 7 earlier versions
  1. Site contact updatedv8
  2. Re-verified, no change to tracked fieldsv7
  3. Primary completion date: Oct 31, 2020 to Oct 2024
    • Study completion date: Oct 31, 2024 to Oct 2024
    v6
  4. Start date changed from estimate of Mar 2020 to Mar 19, 2020v5
  5. Start date: Nov 2019 to Mar 2020v4
  6. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v3
  7. Re-verified, no change to tracked fieldsv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The purpose of this research study is to study the effect of giving nivolumab with CCR2/5-inhibitor or anti-IL-8 before surgery, and after surgery, with the goal of determining if this medicine results in: 1. A significant immune response against their tumor (which the study team will see in the tumor that is taken out at the time of surgery) 2. Improvement in long term survival rates
Trial Details
NCT Number NCT04123379
Lead Sponsor Icahn School of Medicine at Mount Sinai
Collaborators: Bristol-Myers Squibb
Conditions
(from sponsor)		 Non-small Cell Lung Cancer, Hepatocellular Carcinoma
Related terms Carcinoma, Hepatocellular, Carcinoma, Non-Small-Cell Lung
Enrollment 48 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov