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

NCT ID: NCT04056026

Last Updated: 2019-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-18

Study Completion Date

2018-12-18

Brief Summary

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

Detailed Description

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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

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Mesothelioma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fecal Microbiota Transplant

The patient will undergo fecal microbiota transplant. The 600cc of donor stool will be transplanted by colonoscopy.

Group Type EXPERIMENTAL

Fecal Microbiota Transplant

Intervention Type BIOLOGICAL

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

Interventions

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Fecal Microbiota Transplant

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

Intervention Type BIOLOGICAL

Other Intervention Names

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FMT

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ProgenaBiome

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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ProgenaBiome

Ventura, California, United States

Site Status

Countries

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United States

Other Identifiers

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ProgenaBiome-001

Identifier Type: -

Identifier Source: org_study_id

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