drugset / Trial / NCT07803562

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

NCT07803562 ↗

Phase 2 Not yet recruiting 34 enrolled University of California, San Diego Immunocore Ltd · collab
NaSequentialOpen-labelPrevention

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. 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).

Timeline

Start
2026-11
Primary completion
2028-12
Completion
2030-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexamethasone Small molecule 2 mg —
Subject Dexamethasone Small molecule 4 mg —

Indications