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

  • sponsor
Updated on 28 February 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 February 2022


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Inclusion Criteria

Men or women ≥18 years of age
Screened negative for COVID-19 symptoms at time of consent, as per institutional policy and as applicable for the duration of the COVID-19 pandemic
Diagnosed with stages I-IV primary NSCLC, MM, TNBC or RCC
Plan to be treated at a partner cancer site with a checkpoint inhibitor (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
Able to provide informed consent and answer study questionnaires in either English or Spanish
Able to provide stool specimens for research purposes

Exclusion Criteria

Mental incapacity
Incarcerated individuals
Pregnancy (by self-report of pregnancy status)
Experiencing active brain metastasis/metastases
Treatment with checkpoint inhibitor in off-label capacity or through a clinical/interventional trial
Active participation in an immuno-oncology clinical/interventional trial or pharma-sponsored observational study
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