A Single Dose FMT Infusion as an Adjunct to Keytruda for Metastatic Mesothelioma

September 19, 2019 updated by: ProgenaBiome

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

The investigators propose to ensure a favorable gut microbiome by fecal microbiota transplant to enhance the efficacy Keytruda

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Ventura, California, United States, 93003
        • ProgenaBiome

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fecal Microbiota Transplant
The patient will undergo fecal microbiota transplant. The 600cc of donor stool will be transplanted by colonoscopy.
Biological: Fecal Microbiota Transplant
Fecal material from a healthy family donor will be transplanted into the patient via colonoscopy
Other Names:
  • FMT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival
Time Frame: Five years
The time from transplant that the patient's tumors remain stable or shrink.
Five years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ProgenaBiome

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 18, 2018

Primary Completion (Actual)

December 18, 2018

Study Completion (Actual)

December 18, 2018

Study Registration Dates

First Submitted

August 7, 2019

First Submitted That Met QC Criteria

August 8, 2019

First Posted (Actual)

August 14, 2019

Study Record Updates

Last Update Posted (Actual)

September 23, 2019

Last Update Submitted That Met QC Criteria

September 19, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ProgenaBiome-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe