NCT04056026

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Sep 2018

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 18, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 14, 2019

Completed
Last Updated

September 23, 2019

Status Verified

September 1, 2019

Enrollment Period

3 months

First QC Date

August 7, 2019

Last Update Submit

September 19, 2019

Conditions

Mesothelioma

Outcome Measures

Primary Outcomes (1)

  • Progression free survival

    The time from transplant that the patient's tumors remain stable or shrink.

    Five years

Study Arms (1)

Fecal Microbiota Transplant

EXPERIMENTAL

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

Biological: Fecal Microbiota Transplant

Interventions

Fecal Microbiota TransplantBIOLOGICAL

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

Also known as: FMT
Fecal Microbiota Transplant

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with metastatic mesothelioma deemed a candidate for PD-1 blockade inhibitor therapy

You may not qualify if:

  • Patient unable/unwilling to comply with protocol
  • Patient deemed not a candidate for PD-1 Blockade inhibitor therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ProgenaBiome

Ventura, California, 93003, United States

Location

MeSH Terms

Conditions

Mesothelioma

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

AdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Mesothelial

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeutics

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2019

First Posted

August 14, 2019

Study Start

September 18, 2018

Primary Completion

December 18, 2018

Study Completion

December 18, 2018

Last Updated

September 23, 2019

Record last verified: 2019-09

Locations

US(1)