Feasibility Study of Microbial Ecosystem Therapeutics (MET-4) to Evaluate Effects of Fecal Microbiome in Patients on ImmunOtherapy (MET4-IO)

  • STATUS
    Recruiting
  • End date
    Dec 1, 2023
  • participants needed
    65
  • sponsor
    University Health Network, Toronto
Updated on 1 May 2022

Summary

This study is designed to assess the safety, tolerability and engraftment (cumulative relative abundance) of MET-4 strains when given in combination with immune checkpoint inhibitors (ICIs). There will be a safety cohort (group A) of 5 subjects which will receive MET-4 in addition to standard of care (SOC) ICI. After the safety cohort, 40 patients will be enrolled in group B which will be randomized to MET4 with SOC ICI vs. control group with SOC ICI only. Group C will enroll 20 patients who have already started on SOC ICI and have had first unconfirmed progression of disease and expected to continue with standard ICI treatment. These patients will be randomized to continue receiving standard ICI alone, or SOC ICI with MET4.

Description

Human associated microorganisms (the microbiota) inhabit virtually all surfaces of the human body. The gut is densely colonized by the microbiota which aids in the digestion. Animal and human observational and experimental evidence show a link between gut microbiota and the activation, regulation and function of the immune system. Pre-clinical studies in mouse models have linked the gut microbiota to efficacy of anticancer therapies. Microbial Ecosystem Therapeutics (MET) is a new treatment approach developed as an alternative to fecal transplantation. MET consists of a defined mixture of pure live cultures of intestinal bacteria isolated from a stool sample of a healthy donor.

This study is designed to assess the safety, tolerability and engraftment (cumulative relative abundance) of MET-4 strains when given in combination with immune checkpoint inhibitors (ICIs).

Details
Condition All Solid Tumors
Treatment MET-4
Clinical Study IdentifierNCT03686202
SponsorUniversity Health Network, Toronto
Last Modified on1 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Signed written and voluntary informed consent
Age >=18 years, male or female
Histologically or cytological documented locally-advanced or metastatic solid malignancy which is incurable
Group A: Is already on treatment with monotherapy anti-PD-1 or PD-L1 immune checkpoint inhibitor, not in the context of a therapeutic clinical trial
Group B: Is intended to start on treatment with monotherapy anti-PD-1 or PD-L1 immune
checkpoint inhibitors as considered appropriate by treatment physician, and not in the
context of a therapeutic clinical trial
Group C: Is already on treatment with monotherapy anti-PD-1 or PD-L1 immune checkpoint
inhibitor, not in the context of a therapeutic clinical trial with first unconfirmed PD on
evaluation scan per investigator's assessment
Be willing to provide 10-15 unstained slides of archival tissue sample. Subjects who
decline or have not sufficient archived tissue samples may still enroll if all other
Have measurable disease based on RECIST 1.1
criteria are eligible
Be willing and able to provide stool and blood specimen for analyses at protocol
Prior therapy with any immunotherapy allowed
specified time points
Performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) performance
scale
Not pregnant for females of child bearing potential as indicated by negative serum or
urine pregnancy test within 72 hours of study start

Exclusion Criteria

Pregnant or planning to get pregnant in the next 6 months
Subjects unable to swallow orally administered medications or any subjects with
gastrointestinal disorders likely to interfere with absorption (e.g. bowel
obstruction, short gut syndrome, blind loop syndrome, ileostomy etc). Subjects with
colostomies may be enrolled
Any condition that, in the opinion of the Investigator, would interfere with subject
safety, or evaluation of the collected specimen and interpretation of study result
Clear my responses

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