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

Study acronym: LODEXA
StatusNot Yet Recruiting
PhasePhase 2
Started2026-11
View on ClinicalTrials.gov ↗
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).
Trial Details
NCT Number NCT07803562
Lead Sponsor University of California, San Diego
Collaborators: Immunocore Ltd
Conditions Uveal Melanoma, Metastatic
Enrollment 34 participants
Start Date 2026-11
Primary Completion 2028-12 (estimated)
Study Completion 2030-12 (estimated)
Updated on ClinicalTrials.gov 2026-09-03