Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06630429
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-04
Brief Title:
A Pilot Study of Blood-based Biomarkers for Response to Immune Checkpoint Inhibitors
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Pilot Study of Blood-Based Biomarkers for Response to Immune Checkpoint Inhibitors
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
We propose to conduct a pilot study evaluating baseline and on-treatment changes in tumor fraction TFx in peripheral blood in patients with NSCLC and RCC being treated with checkpoint inhibitor therapy as part of standard of care The primary objective of the study is to determine whether baseline TFx can be reliably predicted in patients with NSCLC and RCC and if changes can be detected during treatment that may correlate with response Exploratory analyses will be completed to assess the potential roles of cachexia-associated inflammation tumor-associated increases in glucocorticoid secretion and ketosisketogenesis in both elevated mAb clearance and in response to ICI therapy Measurements will include circulating IL-6 and other cytokine levels glucocorticoid levels ketone levels and stool analysis for assessment of gut microbiome
Detailed Description:
Primary objective
The primary objective of this protocol is to establish whether TFx can be reliably measured in patients with NSCLC and RCC undergoing treatment with ICI
Secondary objectives
To incorporate and evaluate relationships among other known risk factors for cachexia relative to ICI therapy pharmacokinetics and clinical outcomes to include baseline and longitudinal measures of body weight body composition determinations via L3 CT scans and albumin for cachexia and baseline ICI mAb clearance and changes in clearance over time for PK
To determine whether detected changes in TFx can be appreciated during treatment and whether these changes are associated with clinical benefit by RECIST v11 progression free survival PFS and overall survival OS
Exploratory Objectives
To determine potential roles of cachexia-associated inflammation tumor-associated increases in glucocorticoid secretion and ketosisketogenesis in both elevated mAb clearance and in response to ICI therapy by RECIST 11 PFS and OS
This includes measurement of cytokines and other signaling markers including but not limited to IL-6 Interferon-γ and TGF-β
Endogenous glucocorticoids and ketones
Soluble PD-L1
Ki-67PD-1CD8 T cells Treg cells and PBMC analysis for measurement of expression of FcRn
To quantify the performance of a modifiable biomarker - the gut microbiome - to use as a predictive indicator of clinical benefit in lung cancer patients who receive randomized treatment combinations
To determine whether TFx changes differ by stage of cancer or setting of ICI therapy in NSCLC 11
To compare peripheral blood changes in inflammation including CD8 T Cells and Treg
The primary objective of this protocol is to establish whether TFx can be reliably measured in patients with NSCLC and RCC undergoing treatment with ICI
Secondary objectives
To incorporate and evaluate relationships among other known risk factors for cachexia relative to ICI therapy pharmacokinetics and clinical outcomes to include baseline and longitudinal measures of body weight body composition determinations via L3 CT scans and albumin for cachexia and baseline ICI mAb clearance and changes in clearance over time for PK
To determine whether detected changes in TFx can be appreciated during treatment and whether these changes are associated with clinical benefit by RECIST v11 progression free survival PFS and overall survival OS
Exploratory Objectives
To determine potential roles of cachexia-associated inflammation tumor-associated increases in glucocorticoid secretion and ketosisketogenesis in both elevated mAb clearance and in response to ICI therapy by RECIST 11 PFS and OS
This includes measurement of cytokines and other signaling markers including but not limited to IL-6 Interferon-γ and TGF-β
Endogenous glucocorticoids and ketones
Soluble PD-L1
Ki-67PD-1CD8 T cells Treg cells and PBMC analysis for measurement of expression of FcRn
To quantify the performance of a modifiable biomarker - the gut microbiome - to use as a predictive indicator of clinical benefit in lung cancer patients who receive randomized treatment combinations
To determine whether TFx changes differ by stage of cancer or setting of ICI therapy in NSCLC 11
To compare peripheral blood changes in inflammation including CD8 T Cells and Treg
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None