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).
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.
Use of systemic corticosteroid (including hydrocortisone) within 3 weeks of study entry.
Pregnancy or lactation.
Known severe hypersensitivity reaction to monoclonal antibodies or biologics.
Sequential
Dexamethasone
DrugProphylactic low-dose dexamethasone premedication
Grade ≥2 cytokine release syndrome
Proportion of participants with grade ≥2 cytokine release syndrome
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University of California, San Diego
Lead sponsor
Immunocore Ltd
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
