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

ProgenaBiome

Status and phase: Completed; Early Phase 1

Conditions: Mesothelioma

Treatments: Biological: Fecal Microbiota Transplant

Study type: Interventional

Funder types: Other

Identifiers

NCT04056026

ProgenaBiome-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 1 patient

Sex: All

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

Fecal Microbiota Transplant

Experimental group

Description:

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

Treatment:

Biological: Fecal Microbiota Transplant