Observational Study of Gut Microbiome and Immunotherapy for Solid Tumors
This study is looking at how the bacteria in your gut (your "gut microbiome") might affect how well immunotherapy works for certain cancers. It's an observational study, meaning researchers will collect information without giving you a new treatment. You could be eligible if you are 18 or older, have non-small cell lung cancer, melanoma, renal cell carcinoma, or triple-negative breast cancer, and are planning to be treated with an immune checkpoint inhibitor (like anti-PD-1, anti-PD-L1, or anti-CTLA-4). The main goal is to see how your gut microbiome changes after about 6-8 weeks of immunotherapy by analyzing stool samples. The study aims to enroll 800 patients.
- Study design
- This is an observational study planning to enroll 800 participants. Researchers will collect information without assigning a specific treatment.
- What's involved
- You would provide stool samples before starting immunotherapy and again after about 6-8 weeks of treatment.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint measures changes in the microbiome from before treatment to after Cycle 2 of checkpoint therapy (approximately 6-8 weeks).
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
The Gut Microbiome and Immune Checkpoint Inhibitor Therapy in Solid Tumors
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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What this trial measures
- Change in microbiome composition from baseline to after Cycle 2 of checkpoint therapy (6-8 weeks) by analyzing longitudinally-collected stool specimens of 800 patients with primary NSCLC, MM, RCC, and TNBCprior to initiation of checkpoint therapy (i.e. "Baseline") and at the end of Cycle 2 of checkpoint blockade immunotherapy (at approximately 6-8 weeks) ]
Microbiome evaluation with whole metagenome shotgun sequencing to assess changes in the relative abundance of microbial taxa (measured as percentage abundance per microbial species and changes in percentage abundance between baseline and cycle 2 timepoints) in patients who are receiving checkpoint blockade immunotherapy as the standard of care