NCT04056026

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

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: ProgenaBiome · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Mesothelioma

Interventions

Type	Name	Description
BIOLOGICAL	Fecal Microbiota Transplant	Fecal material from a healthy family donor will be transplanted into the patient via colonoscopy

Timeline

• Start date: 2018-09-18
• Primary completion: 2018-12-18
• Completion: 2018-12-18
• First posted: 2019-08-14
• Last updated: 2019-09-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study