Can a dose of healthy gut bacteria supercharge cancer immunotherapy?
NCT ID NCT03686202
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study tests a treatment called MET-4, which is a defined mix of live bacteria from a healthy donor's stool, given to cancer patients alongside standard immunotherapy. The goal is to see if it is safe and can improve how well the immune system fights solid tumors. About 65 adults with advanced solid tumors will participate, and researchers will measure changes in gut bacteria and any side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- MET-4 (a defined mixture of live intestinal bacteria from a healthy donor)
- What this could lead to
- If it works, this could point toward a way to boost the effectiveness of immunotherapy in solid tumors by improving the gut microbiome.
- What could go wrong
- This is an early feasibility study with only 65 participants, so results may not apply broadly. Adding bacteria could also cause side effects like infections or digestive issues.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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About 65 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2018
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 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. * Pregnant or planning to get pregnant in the next 6 months.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada