University of California, San Diego
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).
This is a single-arm multi-site phase II study of prophylactic low-dose dexamethasone premedication in patients receiving tebentafusp per standard of care for HLA-A\*02:01-positive advanced uveal melanoma. Dexamethasone doses (2 and 4 mg) will be tested sequentially per a Simon's optimal two-stage design. Tebentafusp is a first-in-class, bispecific gp100 peptide and CD3 T-cell engager shown to improve overall survival of HLA-A\*02:01-positive patients with untreated, advanced uveal melanoma. The most common treatment-related adverse event associated with tebentafusp is cytokine release syndrom…
Inclusion Criteria: 1. Provision of signed and dated informed consent form. 2. Stated willingness to comply with all study procedures and availability for the duration of the study. 3. Age ≥18 years. 4. Histologically confirmed advanced uveal melanoma. 5. HLA-A\*02:01 positive as determined per standard of care before enrollment in the study. 6. Planned treatment with tebentafusp as first-line systemic therapy for advanced uveal melanoma per standard of care. 7. For participants able to become pregnant: use of highly effective contraception for at least 4 weeks prior to initiation of tebentaf…
Prophylactic low-dose dexamethasone premedication
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