A Single Dose FMT Infusion as an Adjunct to Keytruda for Metastatic Mesothelioma
Early Phase 1
Completed
- Conditions
- Mesothelioma
- Registration Number
- NCT04056026
- Lead Sponsor
- ProgenaBiome
- Brief Summary
The investigators propose to ensure a favorable gut microbiome by fecal microbiota transplant to enhance the efficacy Keytruda
- Detailed Description
Studies have shown that a favorable microbiome can be the difference between response and non-response of certain cancer treatments such as PD-1 blockade inhibitors. As such the investigators propose to ensure a favorable microbiome in this patient by fecal microbiota transplant to enhance the efficacy of such a drug, Keytruda.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Progression free survival Five years The time from transplant that the patient's tumors remain stable or shrink.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
ProgenaBiome
🇺🇸Ventura, California, United States
ProgenaBiome🇺🇸Ventura, California, United States