NCT07803562Not yet recruitingPhase 2
Low Dose Dexamethasone for the Prevention of Cytokine Release Syndrome Associated With Tebentafusp
Low-Dose Dexamethasone Premedication for the Prevention of Cytokine Release Syndrome Associated With Tebentafusp in Advanced Uveal Melanoma
Source: ClinicalTrials.gov · Last updated 3 Sept 2026
Brief summary (registry, in English)
The goal of this clinical trial is to learn if a low dose of dexamethasone can prevent cytokine release syndrome in participants treated with tebentafusp for advanced uveal melanoma. The main questions the study aims to answer are: How many participants get cytokine release syndrome? How severe is the cytokine release syndrome? What other side effects happen due to dexamethasone and/or tebentafusp? Participants will be treated with tebentafusp per standard practices. For this study, participants will receive dexamethasone before infusion of the first 4 doses of tebentafusp. Participants will have visits for checkups and tests at the time they are given the medications and 9 weeks after they started. Other visits will be approximately every 6 months for at least 2 years and can be done in person or remotely (telehealth).
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 34 (estimated)
- First submitted
- 29 Aug 2026
- Start date
- Nov 2026
- Primary completion date
- Dec 2028
- Lead sponsor
- University of California, San Diego
- Diseases
- Melanoma
- NCT number
- NCT07803562
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 34
- From Nov 2026 to the primary completion date, Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of systemic corticosteroid (including hydrocortisone) within 3 weeks of study entry.
Other illness
- Known severe hypersensitivity reaction to monoclonal antibodies or biologics.
Other
- Pregnancy or lactation.
Who the study is looking for
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Age ≥18 years.
- Histologically confirmed advanced uveal melanoma.
- HLA-A\*02:01 positive as determined per standard of care before enrollment in the study.
- Planned treatment with tebentafusp as first-line systemic therapy for advanced uveal melanoma per standard of care.
- 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.
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of California San Diego Coordinator of this site? Confirm its status | La Jolla | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.