The Gut Microbiome and Immunotherapy Response in Solid Cancers

NCT06050733 | Recruiting

• 1 other identifier: 23-0028
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

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 death ligand (PD-L1) blockade.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• Characterization of fecal microbiome using molecular methods

  Characterization of the fecal microbiome using a commercially available sampling kit and our lab's patented array for PCR.

  baseline

Secondary Outcomes (4)

• Cognitive Function as measured by Montreal Cognitive Assessment

  baseline

• Fatigue as measured by the Multidimensional Fatigue Symptom Inventory

  baseline

• Fatigue and Cognition as measured by the Fatigue and Altered Cognition Scale

  baseline

• Gastrointestinal Health measured by the Gastrointestinal Symptom Rating Scale

  baseline

Study Arms (2)

Solid cancer patients with disease progression

8 patients with a diagnosis of solid cancer undergoing standard of care treatment, with a PD-1 or PD-L1 inhibitor, with disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 guidelines.

Solid cancer patients with stable or experience shrinkage in tumor size

8 patients with a diagnosis of solid cancer undergoing standard of care treatment, with a PD-1 or PD-L1 inhibitor, with tumor size stable or shrinkage, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 guidelines.

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients from cancer clinic

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

University of Texas Medical Branch

Galveston, Texas, 77845, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Melinda Sheffield-Moore, PhD

  University of Texas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristen McGovern, PhD

CONTACT

409-772-8126; kamcgove@utmb.edu

Kate Randolph, BS

CONTACT

409-223-7891; kmrandol@utmb.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2023
• First Posted: September 22, 2023
• Study Start: June 30, 2023
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)