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

Arm | Intervention/treatment |
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Experimental: Fecal Microbiota Transplant
The patient will undergo fecal microbiota transplant. The 600cc of donor stool will be transplanted by colonoscopy.
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Biological: Fecal Microbiota Transplant
Fecal material from a healthy family donor will be transplanted into the patient via colonoscopy
Other Name: FMT |
- Progression free survival [ Time Frame: Five years ]The time from transplant that the patient's tumors remain stable or shrink.

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

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
United States, California | |
ProgenaBiome | |
Ventura, California, United States, 93003 |
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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Mesothelioma Mesothelioma, Malignant Adenoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Mesothelial |
Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Pleural Neoplasms Lung Diseases Respiratory Tract Diseases |