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MET-4 for Cancer (MET4-IO Trial)

Phase 2 & 3

Waitlist Available

Led By Lillian Siu, MD

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) performance scale.

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

MET4-IO Trial Summary

This trial is testing the safety of a new strain of bacteria given with standard cancer treatments. There will be a small safety group, then a larger group that is randomly assigned to either the new treatment or standard treatment. There is also a group for people who have already started standard treatment and are expected to continue it.

Who is the study for?

Adults with advanced solid tumors who are either starting or already on anti-PD-1/PD-L1 immunotherapy, not part of another clinical trial. They must be able to provide tissue samples, stool and blood for analysis, have measurable disease, and a performance status of 0-2. Women must not be pregnant. Those with gastrointestinal disorders affecting absorption cannot join.Check my eligibility

What is being tested?

The study is testing MET-4's safety and its ability to integrate into the body when used with standard immune checkpoint inhibitors (ICIs). Participants are divided into groups: one receiving MET-4 plus ICI therapy; others getting only ICI therapy; some who've seen disease progression on ICIs may also receive MET-4.See study design

What are the potential side effects?

Potential side effects include those commonly associated with fecal microbiome transplants such as digestive upset, infection risk due to altered gut bacteria, and any typical reactions related to immune checkpoint inhibitors like fatigue or skin issues.

MET4-IO Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself and am up and about more than half of my waking hours.

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I am currently on a PD-1 or PD-L1 inhibitor treatment, not as part of another clinical trial.

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I am starting on a specific immune therapy not part of another clinical trial.

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My cancer is advanced, has spread, and cannot be cured.

MET4-IO Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Changes in relative abundance of immunotherapy-responsiveness associated MET-4 strains between baseline and approximately day 12

Cumulative relative abundance of immunotherapy-responsiveness associated species at day 12 of MET-4

Number of participants with treatment-related adverse events assessed by CTCAE v.5.0

Secondary outcome measures

Bacterial taxonomic diversity between baseline and follow-up samples

Changes in relative abundance of immunotherapy-responsiveness associated MET-4 strains between baseline and later MET-4 or control timepoints (approximately 24 weeks and/or 1-2 weeks following the end of treatment)

Cumulative relative abundance of immunotherapy-responsiveness associated species at later MET-4 or control time points (approximately 24 weeks and/or 1-2 weeks following the end of treatment).

Other outcome measures

Changes in immune cell subsets in the systemic circulation in response to MET-4 through serial blood sampling.

Characterization of tumor microenvironment of archived tumor samples

Dynamic measures of microbiome as correlates of blood immune profiling

+2 more

MET4-IO Trial Design

4Treatment groups

Experimental Treatment

Group I: Group DExperimental Treatment1 Intervention

In group D, eligible subjects with stage III or resected stage IV melanoma who are to start adjuvant ICI, will be randomized in a 1:1 ratio to receive MET-4 in addition to anti-PD1 antibody +/- anti-CTLA4 antibody as per SOC or control group. Patients will be stratified per BRAF mutation status. Subjects will be administered the same MET-4 dose as subjects in groups A, B and C. MET-4 will be initiated as run-in for a minimum of 1 week, and maximum of 2 weeks before ICI administration. MET-4 will be continued until unacceptable toxicity, confirmed PD by RECIST v1.1 or completion of 1 year of ICI, whichever occurs earlier. Subjects in the control arms of groups B, C and D will be treated with ICI therapy as per institution standard of care without MET-4.

Group II: Group CExperimental Treatment1 Intervention

In group C, eligible subjects with advanced solid tumors whom are already on ICI with first unconfirmed PD on evaluation scans per investigator's assessment, will be randomised in a 1:1 ratio to receive MET-4 in addition to the PD-1/PD-L1 inhibitor as per SOC or control group. These subjects must be clinically stable and are to be continued on ICI at the discretion of the investigator. There will be no run-in period for this cohort. Subjects will be administered the same MET-4 dose as subjects in groups A and B.

Group III: Group BExperimental Treatment1 Intervention

Eligible subjects with advanced solid tumors starting ICI will be randomised in a 3:1 ratio stratifying for prior IO exposure, to receive MET-4 together with any approved PD-1/PD-L1 inhibitor as per SOC or control group. There will be a run-in period for subjects in the MET-4 treatment group. Following the run-in period of ICI therapy, subjects will be administered the same MET-4 dose as subjects in group A.

Group IV: Group A: Safety CohortExperimental Treatment1 Intervention

Subjects with advanced solid tumors already on ICI will receive treatment with MET-4 in addition to SOC ICI. MET-4 is administered orally as an initial daily loading dose (5g) of MET-4 over 2 days followed by a daily maintenance dose (1.5g) of MET-4 and will be continued until unacceptable toxicity, progression of disease

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor

1,468 Previous Clinical Trials

484,425 Total Patients Enrolled

NuBiyotaOTHER

8 Previous Clinical Trials

176 Total Patients Enrolled

Lillian Siu, MDPrincipal InvestigatorPrincess Margaret Cancer Centre

24 Previous Clinical Trials

14,082 Total Patients Enrolled

Media Library

MET-4 Clinical Trial Eligibility Overview. Trial Name: NCT03686202 — Phase 2 & 3

Solid Tumors Clinical Trial 2023: MET-4 Highlights & Side Effects. Trial Name: NCT03686202 — Phase 2 & 3

MET-4 2023 Treatment Timeline for Medical Study. Trial Name: NCT03686202 — Phase 2 & 3

Solid Tumors Research Study Groups: Group D, Group A: Safety Cohort, Group B, Group C

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many patients are participating in this clinical research?

"Following a review of the information available on clinicaltrials.gov, it is confirmed that this medical trial has recently been updated and remains open for recruitment. This study was posted in November 2018 and requires 65 participants to be recruited from one site."

Answered by AI

Are there any vacancies for participants in this research endeavor?

"Indeed, the information listed on clinicaltrials.gov confirms this medical trial is currently recruiting for eligible participants. This research was first posted in November 2018 and has been recently updated in April 2022. 65 volunteers are needed from 1 centre to take part in this study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2018. "Feasibility Study of Microbial Ecosystem Therapeutics (MET-4) to Evaluate Effects of Fecal Microbiome in Patients on ImmunOtherapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03686202.

All > Microbiome