Actively Recruiting
The Gut Microbiome and Immunotherapy Response in Solid Cancers
Led by The University of Texas Medical Branch, Galveston · Updated on 2025-12-19
16
Participants Needed
1
Research Sites
182 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Gut Microbiome and Immunotherapy Response in Solid Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Current diagnosis of malignant solid cancer that is nonresectable or metastatic.
- Ages 35 to 75 years.
- Treatment with PD-1 or PD-L1 inhibitor immunotherapy for at least 3 months but less than 24 months (except previously responsive subjects re-enrolling as non-responsive).
- Measurable disease by RECIST 1.1 guidelines.
- Willing and able to give informed consent.
You will not qualify if you...
- Significant heart, liver, blood, or respiratory disease.
- Current diagnosis of HIV, Hepatitis B, or Hepatitis C.
- History of heart disease.
- Uncontrolled diabetes mellitus.
- History of inflammatory bowel disease, Celiac disease, or active diverticular disease.
- Pregnant or lactating females.
- Chemotherapy treatment within the past 2 years.
- Kinase inhibitor treatment within the past 3 months.
- Previous radiation therapy for brain metastases.
- Other medical conditions or medications deemed exclusionary by investigators.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Texas Medical Branch
Galveston, Texas, United States, 77845
Actively Recruiting
Research Team
K
Kristen McGovern, PhD
CONTACT
K
Kate Randolph, BS
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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