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

Description

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 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.

Conditions

Non-Small Cell Lung CancerRenal Cell Carcinoma (RCC)
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Related Conditions:

Non-Small Cell Lung CancerRenal Cell Carcinoma (RCC)

Study Overview

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Study Details

Study overview

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 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.

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

Condition
Non-Small Cell Lung Cancer
Intervention / Treatment

-

Contacts and Locations

Columbus

The Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States, 43210

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 3. For Cohort A: Patients with stage IB-IV disease 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.
  • 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Ohio State University Comprehensive Cancer Center,

Study Record Dates

2025-12-31