Non Small Cell Lung Cancer (NSCLC), Triple Negative Breast Cancer (TNBC)
Conditions
Brief summary
In Cohort 1, the immunomodulatory role of Atorvastatin will be assessed by comparing the relative change in the density (cells/mm2) of CD8+/PD-1+ cells from T0 to T1 (Cohort 1) between treatment arms, as assessed by multiplex immunofluorescence (mIF) on tumor samples., In Cohort 2, the proportion of patients with a decrease of at least 50% in the percent change of maximum VAF (maxVAF) in ctDNA in the first 6 weeks of treatment (maximum VAFT1−maximum VAFT0/maximum VAFT0) will be compared between treatment arms as a surrogate measure of treatment efficacy.
Detailed description
Efficacy endpoints focused on assessing the impact of adding Atorvastatin to ICI therapy on response rates and survival metrics, such as pathological complete-response rate (pCR) for Cohort 1 and Overall Response Rate (ORR), progression-free survival (PFS) and overall survival (OS) for Cohort 2., Safety objectives will evaluate the risks associated with Atorvastatin and ICI-based therapy, including the incidence and severity of adverse events, graded according to NCI CTCAE v5.0., Translational objectives aimed to identify prognostic and predictive immune-metabolic markers influenced by Atorvastatin and ICI therapies, using technologies such as spatial profiling, RNA-sequencing (RNAseq), plasma metabolomics by Ultra Performance Liquid Chromatography (UPLC)/Mass Spectrometry (MS) and peripheral blood mononuclear cells (PBMCs).
Interventions
DRUGTORVAST 40 mg compresse rivestite con film
Sponsors
Universita Degli Studi Di Padova
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In Cohort 1, the immunomodulatory role of Atorvastatin will be assessed by comparing the relative change in the density (cells/mm2) of CD8+/PD-1+ cells from T0 to T1 (Cohort 1) between treatment arms, as assessed by multiplex immunofluorescence (mIF) on tumor samples., In Cohort 2, the proportion of patients with a decrease of at least 50% in the percent change of maximum VAF (maxVAF) in ctDNA in the first 6 weeks of treatment (maximum VAFT1−maximum VAFT0/maximum VAFT0) will be compared between treatment arms as a surrogate measure of treatment efficacy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy endpoints focused on assessing the impact of adding Atorvastatin to ICI therapy on response rates and survival metrics, such as pathological complete-response rate (pCR) for Cohort 1 and Overall Response Rate (ORR), progression-free survival (PFS) and overall survival (OS) for Cohort 2., Safety objectives will evaluate the risks associated with Atorvastatin and ICI-based therapy, including the incidence and severity of adverse events, graded according to NCI CTCAE v5.0., Translational objectives aimed to identify prognostic and predictive immune-metabolic markers influenced by Atorvastatin and ICI therapies, using technologies such as spatial profiling, RNA-sequencing (RNAseq), plasma metabolomics by Ultra Performance Liquid Chromatography (UPLC)/Mass Spectrometry (MS) and peripheral blood mononuclear cells (PBMCs). | — |
Countries
Italy
Outcome results
None listed