Examining the gut microbiome's role in cancer immunotherapy response
The Gut Microbiome and Immunotherapy Response in Solid Cancers
This study is trying to see if the types of bacteria in the gut can affect how well cancer patients respond to certain immunotherapy treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 16 (estimated) |
| Ages | 35 Years to 75 Years |
| Sex | All |
| Sponsor | The University of Texas Medical Branch, Galveston Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Galveston, Texas) |
| Trial ID | NCT06050733 on ClinicalTrials.gov |
What this trial studies
This observational study aims to characterize the gastrointestinal microbiomes of patients with solid cancers who are undergoing treatment with PD-1 or PD-L1 inhibitors. It seeks to understand the relationship between gut microbiome composition and clinical responses to immunotherapy, particularly focusing on the potential role of specific beneficial bacteria. The study will include patients aged 35 to 75 years who have been on immunotherapy for a specified duration and will assess their microbiome profiles to identify patterns associated with treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 35 to 75 with nonresectable or metastatic solid cancers currently receiving PD-1 or PD-L1 inhibitor therapy.
Not a fit: Patients with significant comorbidities, recent chemotherapy treatment, or specific gastrointestinal diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to personalized microbiome-based interventions that enhance the effectiveness of immunotherapy in cancer patients.
How similar studies have performed: Previous studies have shown promising results with fecal microbiota transplants in enhancing immunotherapy responses, indicating potential for success in this area of research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Current diagnosis of malignant solid cancer that is nonresectable or metastatic. 2. Ages 35 to 75 years. 3. Treatment with immunotherapy, specifically programmed cell death protein 1 (PD-1) or programmed cell death ligand 1 (PD-L1) inhibitor, for at least 3 months but less than 24 months (except for previously responsive subjects re-enrolling as non-responsive patients). 4. Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 guidelines. 5. Participant is willing and able to give informed consent for participation in the study Exclusion Criteria: 1. Significant heart, liver, blood or respiratory disease. 2. Current diagnosis of HIV, Hepatitis B or Hepatitis C. 3. History of heart disease. 4. Uncontrolled diabetes mellitus. 5. Subjects with a history of inflammatory bowel disease, Celiac disease or active diverticular disease. 6. Females who are pregnant or lactating. 7. Treatment with chemotherapy within the past 2 years. 8. Treatment with kinase inhibitors within the past 3 months. 9. Previous radiation therapy for brain metastases. 10. Other medical condition or medication administration deemed exclusionary by the study investigators.
Where this trial is running
Galveston, Texas
- University of Texas Medical Branch — Galveston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Melinda Sheffield-Moore, PhD — University of Texas
- Study coordinator: Kristen McGovern, PhD
- Email: kamcgove@utmb.edu
- Phone: 409-772-8126
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.