NCT06630429Active, not recruiting
A Pilot Study of Blood-based Biomarkers for Response to Immune Checkpoint Inhibitors
Source: ClinicalTrials.gov · Last updated 30 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 100 (actual)
- First submitted
- 4 Oct 2024
- Start date
- 2 Sept 2020
- Primary completion date
- 31 Jul 2027
- Lead sponsor
- Ohio State University Comprehensive Cancer Center
- Diseases
- Kidney cancer, Lung cancer
- NCT number
- NCT06630429
What you commit to
- Study type: Observational
- Participants enrolled: 100
- From 2 Sept 2020 to the primary completion date, 31 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have received previous immune checkpoint inhibitor therapy.
- Other malignancy requiring active ongoing treatment with systemic therapy (excluding hormonal therapy).
- 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.
Other illness
- Patients currently participating in an interventional or therapeutic clinical trial involving the use of active anti-cancer therapy.
Age
- Individuals \<18 years of age
Other
- Unable or unwilling to provide consent.
Who the study is looking for
- Males and females, age ≥ 18 years
- 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.
- Patients planned for standard of care treatment with immune checkpoint inhibitors (ICIs, see appendix 3 for list) either as monotherapy or in combination therapy.
- Scheduled for imaging every 6 to 12 weeks for stage IV NSCLC and RCC as is standard of care per NCCN guidelines.
- Able to read, understand, and provide written informed consent.
- 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
Age in the registry: 18 years to - · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Ohio State University Comprehensive Cancer Center Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.