Low Dose Dexamethasone for the Prevention of Cytokine Release Syndrome Associated With Tebentafusp
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dexamethasone | Small molecule | 2 mg | — |
| Subject | Dexamethasone | Small molecule | 4 mg | — |