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

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04056026

Enrollment

Registered

2019-08-14

Start date

2018-09-18

Completion date

2018-12-18

Last updated

2019-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mesothelioma

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.

Interventions

BIOLOGICALFecal Microbiota Transplant

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026