The Gut Microbiome and Immune Checkpoint Inhibitor Therapy in Solid Tumors

Last updated: April 25, 2022
Sponsor: VastBiome
Overall Status: Active - Recruiting

Phase

N/A

Condition

Renal Cell Carcinoma

Melanoma

Carcinoma

Treatment

N/A

Clinical Study ID

NCT05037825
Pro00054854
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Men or women ≥18 years of age
  2. Screened negative for COVID-19 symptoms at time of consent, as per institutionalpolicy and as applicable for the duration of the COVID-19 pandemic
  3. Diagnosed with stages I-IV primary NSCLC, MM, TNBC or RCC
  4. 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 anothercheckpoint inhibitor or other treatment agent or modality (e.g., targeted therapy,chemotherapy, surgery, radiation, etc.) in accordance with FDA-labeled use of theagent
  5. Able to provide informed consent and answer study questionnaires in either English orSpanish
  6. Able to provide stool specimens for research purposes

Exclusion

Exclusion Criteria:

  1. Mental incapacity
  2. Incarcerated individuals
  3. Pregnancy (by self-report of pregnancy status)
  4. Experiencing active brain metastasis/metastases
  5. Treatment with checkpoint inhibitor in off-label capacity or through aclinical/interventional trial
  6. Active participation in an immuno-oncology clinical/interventional trial orpharma-sponsored observational study

Study Design

Total Participants: 800
Study Start date:
November 22, 2021
Estimated Completion Date:
September 14, 2028

Connect with a study center

  • Baptist Health Clinical Research

    Elizabethtown, Kentucky 42701
    United States

    Active - Recruiting

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