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

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ClinicalTrials.gov Identifier: NCT04056026
Recruitment Status : Completed
First Posted : August 14, 2019
Last Update Posted : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
ProgenaBiome

Study Description
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Brief Summary:
The investigators propose to ensure a favorable gut microbiome by fecal microbiota transplant to enhance the efficacy Keytruda

Condition or disease Intervention/treatment Phase
Mesothelioma Biological: Fecal Microbiota Transplant Early Phase 1

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 18, 2018
Actual Primary Completion Date : December 18, 2018
Actual Study Completion Date : December 18, 2018

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Fecal Microbiota Transplant
The patient will undergo fecal microbiota transplant. The 600cc of donor stool will be transplanted by colonoscopy.
 Biological: Fecal Microbiota Transplant
Fecal material from a healthy family donor will be transplanted into the patient via colonoscopy
Other Name: FMT


Outcome Measures
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Primary Outcome Measures :
  1. Progression free survival [ Time Frame: Five years ]
    The time from transplant that the patient's tumors remain stable or shrink.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04056026


Locations
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United States, California
ProgenaBiome
Ventura, California, United States, 93003
Sponsors and Collaborators
ProgenaBiome
More Information
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Additional Information:

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Responsible Party: ProgenaBiome
ClinicalTrials.gov Identifier: NCT04056026    
Other Study ID Numbers: ProgenaBiome-001
First Posted: August 14, 2019    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial