VastBiome: The Gut Microbiome and Immune Checkpoint Inhibitor Therapy in Solid Tumors

    Not Recruiting
  • sponsor
Updated on 28 September 2022
programmed cell death 1 ligand 1
cancer chemotherapy
targeted therapy


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.


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

Condition Renal Cell Carcinoma, Non-Small Cell Lung Cancer, Malignant Melanoma, Breast Cancer
Clinical Study IdentifierTX291213
Last Modified on28 September 2022

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