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Study aims to unlock secrets of immunotherapy skin reactions

NCT ID NCT04283539

Knowledge-focused Sponsor: National Jewish Health 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study observed 255 cancer patients receiving immunotherapy to understand why some develop skin side effects. Researchers measured immune markers and lipids in the skin and blood. The goal is to identify patterns that could predict or explain these reactions.

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 better predict and manage skin side effects from cancer immunotherapy.
What could go wrong
This is an observational study, not testing a new treatment. It may not lead to direct changes in patient care.

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

255 people

The number who actually took part.

Started

Sep 2020

Finished

Feb 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 male or female with diagnosis of solid tumor

Ages

18 to 99 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. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, \>18 yo 4. Diagnosis of solid tumor including, but not limited to, genitourinary/gynecologic, lung, gastrointestinal and melanoma 5. Received or receiving a Check Point Inhibitor, or prior to starting on a checkpoint inhibitor 6. Grade ≥ 1 ircAE (CTCAE v 5.0) (for cohort 1 only) 7. No ircAE (cohort 2 only) 8. An indication for system corticosteroids or biologic therapies as determined by the treating physician (for cohort 1 only) 8\. Life expectancy ≥ 12 weeks Exclusion Criteria: 1. Daily use of systemic steroid treatment in the past 4 weeks (prednisone \>10mg a day or equivalent) except for indications other than the cutaneous adverse event, and/or as an anti-emetic pre- or post-chemotherapy infusions. 2. Enrollment in any investigational drug trial with a drug that has not been approved 3. Taking other checkpoint inhibitors beyond anti-PD-(L)-1 or anti-CTLA-4 not yet indicated/approved for use 4. Pregnancy 5. Known blood borne infectious disease 6. Current or previous diagnosis of a leukemia or lymphoma 7. Unable to give consent for study participation 8. Life expectancy \< 12 weeks 9. Any other condition or diagnosis in the opinion of the investigator that would interfere with the study results

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Conditions

The condition(s) this trial relates to.

cancer neoplasm skin disorder

As listed by the trial registrant

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

Cancer Immunotherapy Patients with solid tumors receiving immunotherapy with an ici will be randomized to participate in an sdoh and side effects navigation program VS. control Skin disease

Contacts and locations

Locations

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • National Jewish Health

    Denver, Colorado, 80206, United States

  • The Melanoma and Skin Cancer Institute

    Denver, Colorado, 80206, United States

More trials for these conditions

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