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Completed

NCT Number: NCT04056026

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

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

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Key information

Conditions

Mesothelioma Adenoma Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Neoplasms, Mesothelial

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

ProgenaBiome

Ventura, California, 93003, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fecal Microbiota Transplant

Biological

Fecal material from a healthy family donor will be transplanted into the patient via colonoscopy

Other names: FMT

Primary outcomes

  1. Progression free survival

    Time frame: Five years

    The time from transplant that the patient's tumors remain stable or shrink.

Sponsors and collaborators

Lead sponsor

ProgenaBiome

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 14, 2019
Registry last updated
Sep 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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