Memory-Like Natural Killer Cells With Nivolumab and Relatlimab in Advanced or Metastatic Melanoma After Progression on Checkpoint Inhibitors

StatusSuspended
PhasePhase 1
Started

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Record History

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  1. Recruitment suspended Sponsor's reason: Reviewing safety data
    • Eligibility criteria expanded, about 21 words
    • Secondary endpoints: details revised at 3 of 5 entries
    • Site details revised
  2. Re-verified, no change to tracked fieldsv12
  3. Eligibility criteria shortened, about 11 wordsv11
  4. Eligibility criteria expanded, about 2 wordsv10
  5. Trial status: Not Yet Recruiting to Recruitingv9 Show 4 more changesShow less
    • Primary completion date: Jan 31, 2029 to Feb 28, 2029
    • Study completion date: Oct 31, 2030 to Nov 30, 2030
    • Start date changed from estimate of Oct 31, 2024 to Nov 6, 2024
    • Site details revised
Show 7 earlier versionsHide 7 earlier versions
  1. Start date: Aug 31, 2024 to Oct 31, 2024
    • Primary completion date: Nov 30, 2028 to Jan 31, 2029
    • Study completion date: Aug 31, 2030 to Oct 31, 2030
    v8
  2. Start date: Jun 30, 2024 to Aug 31, 2024
    • Primary completion date: Sep 30, 2028 to Nov 30, 2028
    • Study completion date: Jun 30, 2030 to Aug 31, 2030
    v7
  3. Primary endpoints: 1 to 2v6 Show 5 more changesShow less
    • Interventions: Memory-like natural killer cells (Biological), Nivolumab (Biological), Relatilmab (Biological) to Cytokine-induced memory-like natural killer cells (Biological), Nivolumab (Biological), Relatilmab (Biological)
    • Eligibility criteria expanded, about 198 words
    • Secondary endpoints: details revised at 3 of 5 entries
    • Site contact updated
    • Collaborators expanded, about 6 words
  4. Start date: Mar 31, 2024 to Jun 30, 2024
    • Primary completion date: Jun 30, 2028 to Sep 30, 2028
    • Study completion date: Mar 31, 2030 to Jun 30, 2030
    v5
  5. Primary completion date: Dec 31, 2027 to Jun 30, 2028
    • Start date: Sep 30, 2023 to Mar 31, 2024
    • Study completion date: Sep 30, 2029 to Mar 31, 2030
    v4
  6. Start date: Jun 30, 2023 to Sep 30, 2023
    • Primary completion date: Sep 30, 2027 to Dec 31, 2027
    • Study completion date: Jun 30, 2029 to Sep 30, 2029
    v3
  7. Start date: Feb 28, 2023 to Jun 30, 2023
    • Primary completion date: May 31, 2027 to Sep 30, 2027
    • Study completion date: Feb 28, 2029 to Jun 30, 2029
    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 Phase 1 open-label, study designed to characterize the safety, tolerability, and preliminary anti-tumor activity of memory-like natural killer cells (ML NK) in combination with nivolumab and relatlimab in subjects with advanced and/or metastatic melanoma. There will be two arms to test the variables of ML NK cell source. ML NK cells from an autologous source will be used for Arm 1, and ML NK cells from an allogeneic source will be used for Arm 2. The investigators hypothesize that ML NK cells from either an autologous source or allogeneic source are safe and tolerable in subjects with advanced and/or metastatic melanoma.
Trial Details
NCT Number NCT05629546
Lead Sponsor Washington University School of Medicine
Collaborators: Melanoma Research Alliance, Rising Tide Foundation
Conditions
(from sponsor)		 Advanced Melanoma, Metastatic Melanoma
Related terms Melanoma
Enrollment 33 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov