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

Early Phase 1

Completed

• Conditions: Mesothelioma
• Interventions: Biological: Fecal Microbiota Transplant

• Registration Number: NCT04056026
• Lead Sponsor: ProgenaBiome

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 Timeline

• Study Start: 2018-09-18
• Primary Completion: 2018-12-18
• Study Completion: 2018-12-18
• Study First Submitted: 2019-08-07
• Study First Submitted QC: 2019-08-08
• Study First Posted: 2019-08-14
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-19
• Last Update Posted: 2019-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fecal Microbiota Transplant	Fecal Microbiota Transplant	The patient will undergo fecal microbiota transplant. The 600cc of donor stool will be transplanted by colonoscopy.

Primary Outcome Measures

Name	Time	Method
Progression free survival	Five years	The time from transplant that the patient's tumors remain stable or shrink.

Trial Locations

Locations (1)

ProgenaBiome; 🇺🇸 Ventura, California, United States