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Can a simple blood test predict dangerous side effects of immunotherapy?

NCT ID NCT03409016

Knowledge-focused Sponsor: University of Colorado, Denver 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 06, 2026 · Updated 2 times

Summary

This pilot study is looking for biomarkers in the blood that might predict which cancer patients will develop immune-related side effects from immune checkpoint inhibitors. Researchers will compare blood samples from 69 patients with metastatic cancer before and during treatment. The goal is to find early warning signs that could help doctors manage side effects better.

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 cancer patients are at higher risk for immune-related side effects from checkpoint inhibitors.
What could go wrong
This is a small, early pilot study (69 people) that only looks for markers—it does not test a new treatment. The findings may not apply to all cancer types or treatments.

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 69 people

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

Started

Apr 2018

Expected to finish

Oct 2026

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

These patients will be enrolled only at the University of Colorado Cancer Center in the outpatient clinic setting.

Ages

18 to 100 years

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. Metastatic solid tumor cancer of any primary site, with the exception of lymphoma 2. ≥18 years of age 3. Life expectancy \>6 months 4. Starting new regimen of ipilimumab, nivolumab, pembrolizumab or atezolizumab as a single agent or in combination according to standard of care or through compassionate use granted by the pharmaceutical company (immune checkpoint inhibitor arm only) OR Starting new regimen of standard cytotoxic chemotherapy (control arm only) 5. Provision to sign and date the consent form 6. Stated willingness to comply with all study procedures and be available for the duration of the study Exclusion Criteria: 1. Prior immune checkpoint inhibitor therapy with anti-CTLA4, anti-PD1 or anti-PD-L1 targeting agent 2. Known autoimmune disease 3. Known acute or chronic infection, including viral infections such as Hepatitis B, C, and HIV 4. Chronic treatment with immune suppressive medications, including steroids, at the time of study enrollment 5. Concomitant treatment with a monoclonal antibody in addition to cytotoxic chemotherapy (i.e. bevacizumab, cetuximab, trastuzumab) (control arm only) 6. Known pregnancy or lactation

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Conditions

The condition(s) this trial relates to.

cancer metastatic malignant neoplasm metastatic neoplasm neoplasm Neoplasm Metastasis

As listed by the trial registrant

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

Cancer Metastatic cancer

Contacts and locations

Locations

  • University of Colorado Denver

    Aurora, Colorado, 80045, United States

More trials for these conditions

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