The Gut Microbiome and Immunotherapy Response in Solid Cancers

Launched by THE UNIVERSITY OF TEXAS MEDICAL BRANCH, GALVESTON · Sep 15, 2023

Keywords

ClinConnect Summary

This clinical trial, titled "The Gut Microbiome and Immunotherapy Response in Solid Cancers," is focused on understanding how the bacteria living in our intestines (the gut microbiome) might influence how well patients with certain types of cancer respond to immunotherapy treatments. Specifically, the study looks at patients with solid tumors who are receiving a type of immunotherapy called PD-1 or PD-L1 blockade. The researchers want to learn more about the relationship between gut health and treatment outcomes to improve cancer care.

To participate in this study, individuals should be between 35 and 75 years old and currently diagnosed with a specific type of cancer that cannot be surgically removed or has spread to other parts of the body. They should have been receiving immunotherapy for at least 3 months but less than 24 months. However, there are some health issues that would prevent someone from joining, such as serious heart or liver problems, certain infections, or recent treatments like chemotherapy. Participants can expect to provide information about their health and undergo assessments while contributing to valuable research that may help improve treatment for future cancer patients.

Gender

ALL

Eligibility 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.