Feasibility Study of MET-4: Evaluating Fecal Microbiome Effects in Immunotherapy Patients (NCT03686202) | Clinical Trial Compass
Active — Not RecruitingPhase 2/3
Feasibility Study of MET-4: Evaluating Fecal Microbiome Effects in Immunotherapy Patients
Canada65 participantsStarted 2018-11-30
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 criteria are eligible.
* Be willing and able to provide stool and blood specimen for analyses at protocol specified time points.
* Have measurable disease based on RECIST 1.1
* Performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) performance scale.
* Prior therapy with any immunotherapy allowed.
* 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:
* Subjects unable to swallow orally ad…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cumulative relative abundance of immunotherapy-responsiveness associated species at day 12 of MET-4
Timeframe: Approximately 12 days
2
Changes in relative abundance of immunotherapy-responsiveness associated MET-4 strains between baseline and approximately day 12
Timeframe: Approximately 12 days
3
Number of participants with treatment-related adverse events assessed by CTCAE v.5.0