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Gut bacteria may hold key to safer cancer immunotherapy

NCT ID NCT04107311

Knowledge-focused Sponsor: University Health Network, Toronto Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Aug 11, 2026 · Updated 3 times

Summary

This study is collecting stool and blood samples from 120 advanced cancer patients receiving immunotherapy combinations. Researchers want to see if the types of bacteria in the gut and certain immune markers can predict which patients will develop serious side effects. The goal is to find ways to identify high-risk patients early, without adding extra hospital visits.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could help doctors predict which patients are at higher risk for serious side effects from immunotherapy, allowing for better monitoring or prevention.
What could go wrong
This is an observational study, not a treatment trial. It only looks at samples and does not test any new drug or intervention, so it cannot directly improve outcomes.

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.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2019

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

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.

Who is studied

Advanced solid tumor patients receiving immunooncology combinations

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Signed written and voluntary informed consent. 2. Patient must be willing and able to provide collection for blood and stool specimen analysis at the pre-specified time-points. 3. Age \> 18 years, male or female. 4. Patient must be diagnosed with any advanced solid tumor deemed incurable and to be treated at Princess Margaret Cancer Centre. 5. Patients must be eligible to treatment with an IO combination. Exclusion Criteria: 1. Any conditions that in the opinion of the Investigator would interfere with patient safety, or evaluation of the collected specimen and interpretation of study result. 2. History of autoimmune disease with a flare episode within one year before study screening.

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Conditions

The condition(s) this trial relates to.

neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Solid tumor

Contacts and locations

Locations

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9, Canada

More trials for these conditions

Other studies related to the condition(s) this trial covers.