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

Early Phase 1CompletedNCT04056026

ProgenaBiome1 enrolled

Overview

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

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Mesothelioma

Interventions

Fecal Microbiota TransplantBIOLOGICAL

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

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

ProgenaBiome

Ventura, California, United States

Outcomes

Primary Outcomes

Progression free survival

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

Time frame: Five years

Data from ClinicalTrials.gov

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