Uveal Melanoma, MetastaticPhase 2LODEXANCT07803562
Low Dose Dexamethasone for the Prevention of Cytokine Release Syndrome Associated With Tebentafusp
A Phase 2 study testing Dexamethasone in people with Uveal Melanoma, Metastatic, run by University of California, San Diego at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uveal Melanoma, Metastatic
- What is being tested?
- Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Dec 2030
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Use of systemic corticosteroid (including hydrocortisone) within 3 weeks of study entry.
- Pregnancy or lactation.
- Known severe hypersensitivity reaction to monoclonal antibodies or biologics.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of California, San Diego
La Jolla, California, 92093
About this study
Official title: Low-Dose Dexamethasone Premedication for the Prevention of Cytokine Release Syndrome Associated With Tebentafusp in Advanced Uveal Melanoma
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).
Read the detailed description
This is a single-arm multi-site phase II study of prophylactic low-dose dexamethasone premedication in patients receiving tebentafusp per standard of care for HLA-A*02:01-positive advanced uveal melanoma. Dexamethasone doses (2 and 4 mg) will be tested sequentially per a Simon's optimal two-stage design. Tebentafusp is a first-in-class, bispecific gp100 peptide and CD3 T-cell engager shown to improve overall survival of HLA-A*02:01-positive patients with untreated, advanced uveal melanoma. The most common treatment-related adverse event associated with tebentafusp is cytokine release syndrome. Given the significant patient and health system burden of cytokine release syndrome in tebentafusp-treated patients, the investigators plan to use prophylactic low-dose dexamethasone premedication. The investigators hypothesize that this strategy will decrease the incidence and severity of cytokine release syndrome. Improvements in the safety and tolerability of tebentafusp could enable broader use of tebentafusp in outpatient and community settings and reduce hospitalization-related costs and barriers to care.
- Conditions
- Uveal Melanoma, Metastatic
- Being tested
- Dexamethasone
- Keywords
- Tebentafusp, Dexamethasone, Cytokine release syndrome, Prophylaxis
- Medical subject headings
- Uveal Melanoma, Neoplasm Metastasis, Cytokine Release Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called Decadron, Dexasone, Hexadrol, Ozurdex
Prophylactic low-dose dexamethasone premedication
| Study group | Role | What they receive |
|---|---|---|
| Prophylactic low-dose dexamethasone | Experimental | Low-dose dexamethasone premedication in patients receiving the first 4 doses of tebentafusp Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grade ≥2 cytokine release syndrome
Proportion of participants with grade ≥2 cytokine release syndrome
Measured: During the first 4 doses of tebentafusp treatment (fourth dose is on day 22)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study startNov 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uveal Melanoma, MetastaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Simon two-stage design
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Immunocore Ltd
- Responsible party
- Principal investigator, Soo Park, University of California, San Diego
- Investigators
- Soo Park, MD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07803562
- Sponsor's protocol ID
- 814015
- Acronym
- LODEXA
- Status last verified
- Sep 2026
- First submitted
- 29 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No