Exploring the gut microbiome's role in cancer treatment response

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study investigates how the gut microbiome may influence the effectiveness of immune checkpoint inhibitor therapy in patients with various solid tumors, including non-small-cell lung carcinoma, malignant melanoma, renal cell carcinoma, and triple-negative breast cancer. By collecting longitudinal samples and assessing the composition and function of gut microbiota, the study aims to identify potential biomarkers for clinical response to immunotherapy. Participants will provide stool specimens and undergo treatment with checkpoint inhibitors while their microbiome data is analyzed to understand its relationship with treatment outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Men or women ≥18 years of age
2. 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
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 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
5. Able to provide informed consent and answer study questionnaires in either English or Spanish
6. Able to provide stool specimens for research purposes

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 a clinical/interventional trial
6. Active participation in an immuno-oncology clinical/interventional trial or pharma-sponsored observational study

Where it's running

• Baptist Health Clinical Research
  Elizabethtown, Kentucky, United States Recruiting

Study contacts

• Study coordinator: Hanane Arib, MS
• Email: Hanane@vastbiome.com
• Phone: 650-479-5539

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.