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

StatusActive, Not Recruiting
PhaseNot specified
Started2020-09-02
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Jul 31, 2026 → Jul 31, 2027
See other at-risk trials from Ohio State University Comprehensive Cancer Center

Amendment history

2026-10-01
Primary completion pushed: 2026-07-31 → 2027-07-31
Completion pushed: 2026-07-31 → 2027-07-31
2025-11-06
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v2
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 1 of 1 site
2025-10-14
Study Status, Oversight, Study Description, Outcome Measures, Eligibility v1
Primary completion date2025-12-31→2026-07-31
Completion date2025-12-31→2026-07-31
Eligibility criteria+135 characters
[...] mous, 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 line treatment with immunotherapy alone or in combination nivolumabtherapy andfor ipilimumabmetastatic disease or as adjuvant or neoadjuvant therapy. For Cohort A: Patients with stage IB-IV disease planned for standard of care treatment with immune checkpoi [...] Life expectancy ≥ 3 months Exclusion Criteria: Individuals &lt;<18 years of age Patients [...]
2024-10-04
Original filing
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.
Trial Details
NCT Number NCT06630429
Lead Sponsor Ohio State University Comprehensive Cancer Center
Conditions Non-Small Cell Lung Cancer, Renal Cell Carcinoma (RCC)
Enrollment 100 participants
Start Date 2020-09-02
Primary Completion 2027-07-31 (estimated)
Study Completion 2027-07-31 (estimated)
Updated on ClinicalTrials.gov 2026-09-30