Status:
RECRUITING
The Gut Microbiome and Immunotherapy Response in Solid Cancers
Lead Sponsor:
The University of Texas Medical Branch, Galveston
Conditions:
Cancer
Eligibility:
All Genders
35-75 years
Brief 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 d...
Detailed 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 patient...
Eligibility Criteria
Inclusion
- Current diagnosis of malignant solid cancer that is nonresectable or metastatic.
- Ages 35 to 75 years.
- 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).
- Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 guidelines.
- Participant is willing and able to give informed consent for participation in the study
Exclusion
- Significant heart, liver, blood or respiratory disease.
- Current diagnosis of HIV, Hepatitis B or Hepatitis C.
- History of heart disease.
- Uncontrolled diabetes mellitus.
- Subjects with a history of inflammatory bowel disease, Celiac disease or active diverticular disease.
- Females who are pregnant or lactating.
- Treatment with chemotherapy within the past 2 years.
- Treatment with kinase inhibitors within the past 3 months.
- Previous radiation therapy for brain metastases.
- Other medical condition or medication administration deemed exclusionary by the study investigators.
Key Trial Info
Start Date :
June 30 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 30 2026
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT06050733
Start Date
June 30 2023
End Date
December 30 2026
Last Update
December 19 2025
Active Locations (1)
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1
University of Texas Medical Branch
Galveston, Texas, United States, 77845