ACTIVE_NOT_RECRUITING

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2020-09-02

Study Completion:2026-07-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06630429

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Not specified

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Locations (Sites)

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210

United States

Collaborators and Investigators

Sponsor: Ohio State University Comprehensive Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-09-02

Study Completion Date2026-07-31

Study Record Updates

Study Start Date2020-09-02

Study Completion Date2026-07-31

Terms related to this study

Additional Relevant MeSH Terms

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