Exploring the gut microbiome's role in cancer treatment response
The Gut Microbiome and Immune Checkpoint Inhibitor Therapy in Solid Tumors
This study is testing how the bacteria in the gut might affect how well cancer patients respond to a specific type of treatment called immune checkpoint inhibitors.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 800 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | VastBiome Industry-sponsored |
| Drugs / interventions | chemotherapy, radiation, immunotherapy |
| Locations | 1 site (Elizabethtown, Kentucky) |
| Trial ID | NCT05037825 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older diagnosed with stages I-IV of specific solid tumors who are planning to receive checkpoint inhibitor therapy.
Not a fit: Patients with mental incapacity, those who are incarcerated, pregnant individuals, or those with active brain metastases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to personalized cancer therapies that enhance treatment efficacy based on individual microbiome profiles.
How similar studies have performed: While the role of the microbiome in cancer treatment is an emerging field, this study's large cohort approach is relatively novel and aims to build upon preliminary findings.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Elizabethtown, Kentucky
- Baptist Health Clinical Research — Elizabethtown, Kentucky, United States (Recruiting)
Study contacts
- Study coordinator: Hanane Arib, MS
- Email: Hanane@vastbiome.com
- Phone: 650-479-5539
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.