Phase I Study of Memory-Like Natural Killer Cells With Nivolumab and Relatlimab in Advanced or Metastatic Melanoma After Progression on Checkpoint Inhibitors
Summary
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.
Arms & interventions
- BiologicalCytokine-induced memory-like natural killer cells
Cell product processing is performed at the Siteman Cancer Center Biological Therapy Core Facility (BTCF).
- BiologicalRelatilmab
Standard of care
- BiologicalNivolumab
Standard of care
Outcome measures
Primary
For treatment with cells from an autologous source: Incidence and severity of adverse events
-As determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)
Time frame: From start of treatment through end of safety follow-up (estimated to be 15 months)
For treatment with cells from an allogeneic source: Incidence and severity of adverse events
-As determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)
Time frame: From start of treatment through end of safety follow-up (estimated to be 15 months)
Secondary
Objective response rate (ORR)
Time frame: Through completion of treatment (estimated to be 12 months)
Duration of response (DOR)
Time frame: Through completion of follow-up (estimated to be 3 years)
Progression-free survival (PFS)
Time frame: Through completion of follow-up (estimated to be 3 years)
Disease control rate (DCR)
Time frame: Through completion of follow-up (estimated to be 3 years)
Overall survival (OS)
Time frame: Through completion of follow-up (estimated to be 3 years)
Eligibility criteria
Study locations (1)
Washington University School of Medicine
St Louis, Missouri, 63110