NCT06630429

A Pilot Study of Blood-based Biomarkers for Response to Immune Checkpoint Inhibitors

A Pilot Study of Blood-Based Biomarkers for Response to Immune Checkpoint Inhibitors

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

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 ketosis/ketogenesis 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 v1.1, 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 ketosis/ketogenesis in both elevated mAb clearance and in response to ICI therapy (by RECIST 1.1, 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-67+PD-1+CD8+ 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

Conditions

• Non-Small Cell Lung Cancer
• Renal Cell Carcinoma (RCC)

Interventions

Type	Name	Description
OTHER	Biospecimen Collection	Undergo collection of blood and stool samples

Timeline

• Start date: 2020-09-02
• Primary completion: 2026-07-31
• Completion: 2026-07-31
• First posted: 2024-10-08
• Last updated: 2025-11-10

Locations

1 site across 1 country: United States