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

Mesothelioma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04056026
• Other study ID #: ProgenaBiome-001
• Status: Completed
• Phase: Early Phase 1
• Start date: September 18, 2018
• Est. completion date: December 18, 2018

Study information

• Verified date: September 2019
• Source: ProgenaBiome
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: December 18, 2018
• Est. primary completion date: December 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Mesothelioma

Intervention

Biological:
• Fecal Microbiota Transplant
Fecal material from a healthy family donor will be transplanted into the patient via colonoscopy

Locations

Country	Name	City	State
United States	ProgenaBiome	Ventura	California

Sponsors (1)

Lead Sponsor	Collaborator
ProgenaBiome

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival	The time from transplant that the patient's tumors remain stable or shrink.	Five years

External Links

•   Could Fecal Transplantation Become Part of PD-1-Based Immunotherapy, Due to Effects of the Intestinal Microbiome?
•   Fine-Tuning Cancer Immunotherapy: Optimizing the Gut Microbiome
•   Gut Bugs May Modulate the Efficacy of Anti-PD1 Immunotherapy
•   Re: Gut Microbiome Influences Efficacy of PD-1-based Immunotherapy Against Epithelial Tumors
•   The role of the microbiota in inflammation, carcinogenesis, and cancer therapy