Clinical trial · Observational
The Gut Microbiome and Immunotherapy Response in Solid Cancers
NCT06050733CI-TRIAL-00099316recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Solid cancer patients with disease progression
- description
- 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.
- label
- Solid cancer patients with stable or experience shrinkage in tumor size
- description
- 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.
Primary outcomes (1)
- measure
- Characterization of fecal microbiome using molecular methods
- timeFrame
- baseline
- description
- Characterization of the fecal microbiome using a commercially available sampling kit and our lab's patented array for PCR.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 35 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.