A Phase II Study of Concurrent Stereotactic Body Radiotherapy With Relatlimab and Nivolumab in Patients With Metastatic Uveal Melanoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- safety and tolerability of the therapy
研究概览
简要总结
This is a phase 2 trial of concurrent stereotactic radiation therapy (SBRT) with immunotherapy with relatlimab and nivolumab for up to two years. SBRT will be given in three doses of 15Gy each to 1-5 separate metastases. Opdualag (nivolumab 480mg and relatlimab 160mg) will be given every 4 weeks for two years
详细描述
Metastatic uveal melanoma has no standard therapy, but there is evidence that both radiation therapy and immunotherapy may be helpful and may be synergistic. This is a phase 2 trial of concurrent stereotactic radiation therapy (SBRT) with immunotherapy with Opdualag (nivolumab 480mg and relatlimab 160mg) for up to two years. SBRT will be given in three doses of 15Gy each to 1-5 separate metastases, limiting the total dosage to 700cc's of normal liver to <15Gy. Opdualag (nivolumab 480mg and relatlimab 160mg) will be given every 4 weeks for two years. Objectives are to determine the safety and tolerability, and iRECIST will be used to determine responses.We will treat up to 50 patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •measurable metastatic uveal melanoma.
- •No concomitant therapy.
- •Prior PD1 or tebendafesp allowed.
- •Performance status 0-
- •No active Hepatitis B.
- •No known HIV infection.
- •WBC>2000, ANC>1500, Hgb >
- •Creatinine < 3 x ULN.
- •AST & ALT < 2.5 x ULN Bilirubin < 2 x ULN.
- •Albumin >2.9
排除标准
- •Liver tumor volume > 50%.
- •Active CNS metastases.
- •Pregnancy.
- •Prior therapy with Opdualag or relatlimab
- •Certain autoimmune diseases.
- •Previous liver embolization or radiation.
- •Use of systemic steroids
研究组 & 干预措施
one arm
see below
干预措施: stereotactic body radiotherapy (Radiation)
one arm
see below
干预措施: Immunotherapy (Drug)
结局指标
主要结局
safety and tolerability of the therapy
时间窗: 5 years
toxicity measured by CTAE graded 3-5 toxicities
次要结局
- Response rate(5 years)