Low Dose Dexamethasone for the Prevention of Cytokine Release Syndrome Associated With Tebentafusp

Part of paid clinical trials in La Jolla, California.

Sponsor
University of California, San Diego
Study ID
NCT07803562
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Uveal Melanoma, Metastatic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dexamethasone — DRUG
    Prophylactic low-dose dexamethasone premedication

Study Details

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).

Key Dates

First listed
Sep 3, 2026
Start date
Nov 30, 2026
Status verified
Sep 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2030

Study Design

Enrollment
34 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION

Arms

  • Experimental: Prophylactic low-dose dexamethasone
    Low-dose dexamethasone premedication in patients receiving the first 4 doses of tebentafusp

Primary Outcome Measure

Grade ≥2 cytokine release syndrome [ Time Frame: During the first 4 doses of tebentafusp treatment (fourth dose is on day 22) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San DiegoLa JollaCalifornia92093-

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University of California, San Diego· La Jolla, CA

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