Evaluating blood biomarkers in lung and kidney cancer patients receiving immune therapy

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

This study is testing if changes in certain blood markers can help doctors understand how well immune therapy works for patients with lung and kidney cancer.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Ohio State University Comprehensive Cancer Center (Academic / other)
• Drugs / interventions: nivolumab, ipilimumab
• Locations: 1 site (Columbus, Ohio)
• Trial ID: NCT06630429 on ClinicalTrials.gov

What this trial studies

This pilot study aims to assess changes in tumor fraction in the blood of patients with non-small cell lung cancer (NSCLC) and renal cell carcinoma (RCC) undergoing treatment with immune checkpoint inhibitors. The primary goal is to determine if baseline tumor fraction can be reliably measured and if changes during treatment correlate with patient responses. Additionally, the study will explore the roles of inflammation, glucocorticoid secretion, and the gut microbiome in treatment outcomes. Patients will provide blood and stool samples for analysis of various biomarkers and clinical outcomes.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with confirmed NSCLC or RCC who are scheduled to receive immune checkpoint inhibitors as part of their standard care.

Not a fit: Patients with early-stage cancer not receiving immune checkpoint inhibitors or those unable to provide the required biospecimens may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved methods for predicting patient responses to immune checkpoint therapy, enhancing treatment personalization.

How similar studies have performed: While this approach is exploratory, similar studies have shown promise in using blood-based biomarkers to predict responses to cancer therapies.

Eligibility criteria

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.

   Cohort B will include patients with confirmed diagnosis of RCC receiving first line treatment with combination nivolumab and ipilimumab.
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.

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.

Where this trial is running

Columbus, Ohio

• The Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States (Recruiting)

Study contacts

• Study coordinator: The Ohio State University Comprehensive Cancer Center

Conditions Non-Small Cell Lung Cancer; Renal Cell Carcinoma