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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04056026
Other study ID # ProgenaBiome-001
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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