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New study aims to unlock mysteries of immunotherapy side effects

NCT ID NCT04656873

Knowledge-focused Sponsor: UNC Lineberger Comprehensive Cancer Center 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 09, 2026 · Updated 2 times

Summary

This study collects medical information and biological samples (blood, urine, stool, etc.) from 32 cancer patients starting or restarting immunotherapy. The goal is to build a research database to better understand why some patients develop immune-related side effects and how to manage them. No new treatments are being tested; it is purely for knowledge gathering.

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 research could help doctors predict and better manage immune-related side effects from cancer immunotherapy.
What could go wrong
This is an observational study, not a treatment trial. It is small (32 participants) and aims to build a database for future research, so direct benefits are unlikely.

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

32 people

The number who actually took part.

Started

May 2021

Finished

Jun 2026

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

Adult cancer patients starting ICI monotherapy or combination therapy at University of North Carolina at Chapel Hill (UNC-CH).

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: * 18 years of age at time of enrollment * Diagnosis of cancer * Starting initial ICI therapy or re-starting ICI treatment after a 2-year gap (including off-label use) at UNC-CH using any currently FDA approved ICI's. Exclusion Criteria: * Prior ICI treatment within the last 2 years, including FDA approved ICIs and those under investigation (clinical trials). * Known and untreated BSL-2+ communicable diseases (active/untreated latent TB, HIV, etc.) or other active infections.

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Conditions

The condition(s) this trial relates to.

autoimmune disease cancer immune system disorder neoplasm

As listed by the trial registrant

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

Autoimmune diseases Immune system diseases Malignancy

Contacts and locations

Locations

  • Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill

    Chapel Hill, North Carolina, 27599, United States

More trials for these conditions

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