Back to resultsA Single Dose FMT Infusion as an Adjunct to Keytruda for Metastatic Mesothelioma
Primary Purpose
Mesothelioma
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Fecal Microbiota Transplant
Sponsored by
About this trial
This is an interventional treatment trial for Mesothelioma
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
Sites / Locations
- ProgenaBiome
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Fecal Microbiota Transplant
Arm Description
The patient will undergo fecal microbiota transplant. The 600cc of donor stool will be transplanted by colonoscopy.
Outcomes
Primary Outcome Measures
Progression free survival
The time from transplant that the patient's tumors remain stable or shrink.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04056026
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
September 18, 2018 (Actual)
Primary Completion Date
December 18, 2018 (Actual)
Study Completion Date
December 18, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ProgenaBiome
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mesothelioma
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fecal Microbiota Transplant
Arm Type
Experimental
Arm Description
The patient will undergo fecal microbiota transplant. The 600cc of donor stool will be transplanted by colonoscopy.
Intervention Type
Biological
Intervention Name(s)
Fecal Microbiota Transplant
Other Intervention Name(s)
FMT
Intervention Description
Fecal material from a healthy family donor will be transplanted into the patient via colonoscopy
Primary Outcome Measure Information:
Title
Progression free survival
Description
The time from transplant that the patient's tumors remain stable or shrink.
Time Frame
Five years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
ProgenaBiome
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Single Dose FMT Infusion as an Adjunct to Keytruda for Metastatic Mesothelioma
We'll reach out to this number within 24 hrs