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Study identifier: NCT05037825 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

The Gut Microbiome and Immune Checkpoint Inhibitor Therapy in Solid Tumors

Condition: Non-Small-Cell Lung Carcinoma · Malignant Melanoma · Renal Cell Carcinoma  ·  Sponsor: VastBiome

PhaseN/A
Planned participants800
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Hanane Arib, MS  ·  650-479-5539  ·  Hanane@vastbiome.com

Peter McCaffrey, MD  ·  650-479-5539  ·  Peter@vastbiome.com

Always discuss trial participation with your own doctor first.

Locations (1)

Baptist Health Clinical ResearchElizabethtown, Kentucky, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT05037825