Clinical trial · Interventional
A Single Dose FMT Infusion as an Adjunct to Keytruda for Metastatic Mesothelioma
A Single Dose FMT Infusion From a Healthy Family Donor Via Colonoscopy as an Adjunct to Keytruda for the Benefit of Improving Efficacy of Immunotherapy for Metastatic Mesothelioma
NCT04056026CI-TRIAL-00040761completedEarly Phase 1ClinicalTrials.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 investigators propose to ensure a favorable gut microbiome by fecal microbiota transplant to enhance the efficacy Keytruda
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 |
|---|---|---|---|
| Mesothelioma | Malignant Mesothelioma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fecal Microbiota Transplant | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Fecal Microbiota Transplant
- description
- The patient will undergo fecal microbiota transplant. The 600cc of donor stool will be transplanted by colonoscopy.
- interventionNames
- Biological: Fecal Microbiota Transplant
Primary outcomes (1)
- measure
- Progression free survival
- timeFrame
- Five years
- description
- The time from transplant that the patient's tumors remain stable or shrink.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Patient with metastatic mesothelioma deemed a candidate for PD-1 blockade inhibitor therapy Exclusion Criteria: * Patient unable/unwilling to comply with protocol * Patient deemed not a candidate for PD-1 Blockade inhibitor therapy
References
Publications (0)
Data not yet available
No reference posted for this study.