A Pilot Study of Blood-based Biomarkers for Response to Immune Checkpoint Inhibitors
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.
Checked against the public recordLast updated Nov 10, 2025 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Not specified
- Study type
- Observational
- Phase
- Not applicable
- Sponsor
- Ohio State University Comprehensive Cancer Center
- Interventions being studied
- Other: Biospecimen Collection
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: 1. Males and females, age ≥ 18 years 2. Cohort A will include patients with confirmed diagnosis of all non-small cell lung cancer (NSCLC) histologies including adenocarcinoma, squamous cell, adenosquamous, sarcomatoid/pleomorphic, and poorly differentiated/NOS, as well as patients diagnosed with malignant pleural mesothelioma. Cohort B will include patients with confirmed diagnosis of RCC (clear cell or any non-clear cell histology) receiving first treatment with immunotherapy alone or in combination therapy for metastatic disease or as adjuvant or neoadjuvant therapy. 3. Patients planned for standard of care treatment with immune checkpoint inhibitors (ICIs, see appendix 3 for list) either as monotherapy or in combination therapy. 4. Scheduled for imaging every 6 to 12 weeks for stage IV NSCLC and RCC as is standard of care per NCCN guidelines. 5. Able to read, understand, and provide written informed consent. g. Willing to provide blood specimen and stool samples for research studies as outlined in the calendar h. ECOG performance status 0-2 i. Life expectancy ≥ 3 months Exclusion Criteria: 1. Individuals \<18 years of age 2. Patients who have received previous immune checkpoint inhibitor therapy. 3. Unable or unwilling to provide consent. 4. Other malignancy requiring active ongoing treatment with systemic therapy (excluding hormonal therapy). 5. Women who are known to be pregnant are excluded. However no additional pregnancy testing out of what would be recommended prior to initiating anti-cancer therapy will be performed solely for this study. 6. Patients currently participating in an interventional or therapeutic clinical trial involving the use of active anti-cancer therapy.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- The Ohio State University Comprehensive Cancer CenterColumbus, Ohio
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 10, 2025. Always confirm current availability with the study team.