RecruitingNCT05037825

The Gut Microbiome and Immune Checkpoint Inhibitor Therapy in Solid Tumors


Sponsor

VastBiome

Enrollment

800 participants

Start Date

Nov 22, 2021

Study Type

OBSERVATIONAL

Conditions

Summary

The microbiome has the potential to serve as a robust biomarker of clinical response to immunotherapy. Additionally, microbial manipulation, through diet, exercise, prebiotics, probiotics, or microbially-derived metabolites, may prove to be beneficial in promoting anti-tumor immune responses. However, large prospective studies in humans with longitudinal sample collection and standardized methods are needed to understand how microbiota and their byproducts affect cancer therapies, particularly among patients undergoing identical therapy but experiencing different outcomes. The proposed observational study builds upon these hypotheses by proposing a large cohort design to further assess the associations between the gut microbiota (composition and function), host immune system, and ICI treatment efficacy across multiple cancer types.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This observational study is collecting stool samples and data from cancer patients being treated with immune checkpoint inhibitors — a class of immunotherapy drugs — to understand how gut bacteria may influence how well the treatment works. **You may be eligible if...** - You are 18 or older - You have been diagnosed with non-small cell lung cancer, melanoma, triple-negative breast cancer, or kidney cancer (stages I–IV) - You are about to start treatment with a checkpoint inhibitor drug at a partner cancer center - You can speak English or Spanish and provide a stool sample **You may NOT be eligible if...** - You have active brain metastases - Your checkpoint inhibitor is being used off-label or through another clinical trial - You are participating in an immunotherapy clinical trial or pharma-sponsored observational study at the same time - You are pregnant - You are incarcerated Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCheckpoint Inhibitor, Immune

anti-PD-1, anti-PD-L1, or anti-CTLA-4 as a single agent or in combination with another checkpoint inhibitor or other treatment agent or modality (e.g., targeted therapy, chemotherapy, surgery, radiation, etc.) in accordance with FDA-labeled use of the agent


Locations(1)

Baptist Health Clinical Research

Elizabethtown, Kentucky, United States

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NCT05037825


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