The Gut Microbiome and Immunotherapy Response in Solid Cancers
The University of Texas Medical Branch, Galveston
Summary
The aim of this study is characterize the gastrointestinal microbiomes of patient with solid cancer undergoing standard of care treatment with programmed cell death protein 1 (PD-1) /programmed cell death ligand (PD-L1) blockade.
Description
Frontline treatment for solid cancers such as renal cell carcinoma includes immunotherapies such as immune checkpoint inhibitor (ICI) therapy. Despite an increase in overall survival in cancer patients undergoing ICI therapy, many patients' tumors are unresponsive or eventually progress. Recent studies indicate that the gut microbiome composition is associated with clinical response to ICI treatment. Following the success of preclinical research, two recent studies investigated the efficacy of fecal microbiota transplant (FMT) from cancer patients responsive to programmed cell-death protein 1…
Eligibility
- Age range
- 35–75 years
- Sex
- All
- Healthy volunteers
- Not specified
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 Crite…
Location
- University of Texas Medical BranchGalveston, Texas