Examining the gut microbiome's role in cancer immunotherapy 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 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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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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.