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A steroid premedication may tame the immune reaction to a melanoma therapy

NCT ID NCT07803562

Prevention Sponsor: University of California, San Diego Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time

Summary

This phase 2 trial tests whether a low dose of the steroid dexamethasone, given before the first four infusions of tebentafusp, can prevent cytokine release syndrome in people with advanced uveal melanoma. Tebentafusp is a standard first-line treatment for this eye cancer, but it can trigger an overactive immune response. Researchers will track how many participants develop cytokine release syndrome, how severe it is, and what other side effects occur. Participants receive dexamethasone before each of the first four tebentafusp doses and are followed for at least two years.

What this could mean

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

Active substance
low-dose dexamethasone given before the first four infusions of tebentafusp
What this could lead to
If it works, this could offer a simple way to reduce a serious side effect of tebentafusp, making the treatment safer and easier for people with advanced uveal melanoma.
What could go wrong
This is a small, early-phase study, so the benefit may not hold up in larger groups. Dexamethasone can also cause its own side effects, and it may not fully prevent cytokine release syndrome.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 34 people

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

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

Dec 2030

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.

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. 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. Age ≥18 years. 4. Histologically confirmed advanced uveal melanoma. 5. HLA-A\*02:01 positive as determined per standard of care before enrollment in the study. 6. Planned treatment with tebentafusp as first-line systemic therapy for advanced uveal melanoma per standard of care. 7. For participants able to become pregnant: use of highly effective contraception for at least 4 weeks prior to initiation of tebentafusp and agreement to use such a method for duration of tebentafusp treatment until 6 months after the last dose of tebentafusp. 8. For participants able to cause a pregnancy: use of condoms or other methods to ensure effective contraception with partner from trial initiation and for duration of tebentafusp treatment until 6 months after the last dose of tebentafusp. Exclusion Criteria: 1. Use of systemic corticosteroid (including hydrocortisone) within 3 weeks of study entry. 2. Pregnancy or lactation. 3. Known severe hypersensitivity reaction to monoclonal antibodies or biologics.

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Conditions

The condition(s) this trial relates to.

cytokine release syndrome Neoplasm Metastasis uveal melanoma

As listed by the trial registrant

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

Uveal melanoma, metastatic

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

  • Contact

    Email: •••••@•••••

Locations

  • University of California, San Diego

    La Jolla, California, 92093, United States

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