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
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Dec 2030
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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.
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)
Why it stopped: Lack of funding
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.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- 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
- 0 participants (actual)
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
- Nov 2026
- First submitted
- 29 Aug 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-Dose Dexamethasone Premedication for the Prevention of Cytokine Release Syndrome Associated With Tebentafusp in Advanced Uveal Melanoma
- ClinicalTrials.gov ID
- NCT07803562
- Acronym / sponsor ID
- LODEXA / 814015
- Conditions
- Uveal Melanoma, Metastatic
- Keywords
- Tebentafusp, Dexamethasone, Cytokine release syndrome, Prophylaxis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Immunocore Ltd
- Study start
- Nov 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 3 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Simon two-stage design
| Arm | Type | Receives |
|---|---|---|
| Prophylactic low-dose dexamethasone | Experimental | Drug: DexamethasoneLow-dose dexamethasone premedication in patients receiving the first 4 doses of tebentafusp |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (3 listed)
- Use of systemic corticosteroid (including hydrocortisone) within 3 weeks of study entry.
- Pregnancy or lactation.
- Known severe hypersensitivity reaction to monoclonal antibodies or biologics.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexamethasoneAlso: Decadron, Dexasone, Hexadrol, OzurdexProphylactic low-dose dexamethasone premedication | Drug | Prophylactic low-dose dexamethasone |
Primary outcome
Grade ≥2 cytokine release syndrome
Time frame: During the first 4 doses of tebentafusp treatment (fourth dose is on day 22)
Proportion of participants with grade ≥2 cytokine release syndrome
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Soo Park, MD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grade ≥2 cytokine release syndrome (time frame: During the first 4 doses of tebentafusp treatment (fourth dose is on day 22)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.