Low-Dose Dexamethasone Premedication for the Prevention of Cytokine Release Syndrome Associated With Tebentafusp in Advanced Uveal Melanoma
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Grade ≥2 cytokine release syndrome
研究概览
简要总结
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).
详细描述
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 syndrome. Given the significant patient and health system burden of cytokine release syndrome in tebentafusp-treated patients, the investigators plan to use prophylactic low-dose dexamethasone premedication. The investigators hypothesize that this strategy will decrease the incidence and severity of cytokine release syndrome. Improvements in the safety and tolerability of tebentafusp could enable broader use of tebentafusp in outpatient and community settings and reduce hospitalization-related costs and barriers to care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •HLA-A*02:01 positive as determined per standard of care before enrollment in the study.
- •Planned treatment with tebentafusp as first-line systemic therapy for advanced uveal melanoma per standard of care.
- •For participants able to become pregnant: use of highly effective contraception for at least 4 weeks prior to initiation of tebentafusp and agreement to use such a method for duration of tebentafusp treatment until 6 months after the last dose of tebentafusp.
- •For participants able to cause a pregnancy: use of condoms or other methods to ensure effective contraception with partner from trial initiation and for duration of tebentafusp treatment until 6 months after the last dose of tebentafusp.
排除标准
- •Use of systemic corticosteroid (including hydrocortisone) within 3 weeks of study entry.
- •Pregnancy or lactation.
- •Known severe hypersensitivity reaction to monoclonal antibodies or biologics.
研究组 & 干预措施
Prophylactic low-dose dexamethasone
Low-dose dexamethasone premedication in patients receiving the first 4 doses of tebentafusp
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Grade ≥2 cytokine release syndrome
时间窗: During the first 4 doses of tebentafusp treatment (fourth dose is on day 22)
Proportion of participants with grade ≥2 cytokine release syndrome
次要结局
未报告次要终点
研究者
Soo Park
Associate Clinical Professor
University of California, San Diego