Brief Title
A Single Dose FMT Infusion as an Adjunct to Keytruda for Metastatic Mesothelioma
Official Title
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
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.
Study Phase
Early Phase 1
Study Type
Interventional
Primary Outcome
Progression free survival
Condition
Mesothelioma
Intervention
Fecal Microbiota Transplant
Study Arms / Comparison Groups
Fecal Microbiota Transplant
Description: The patient will undergo fecal microbiota transplant. The 600cc of donor stool will be transplanted by colonoscopy.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
1
Start Date
September 18, 2018
Completion Date
December 18, 2018
Primary Completion Date
December 18, 2018
Eligibility Criteria
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
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT04056026
Organization ID
ProgenaBiome-001
Responsible Party
Sponsor
Study Sponsor
ProgenaBiome
Study Sponsor
, ,
Verification Date
September 2019