NCT02716948已完成1 期
A Pilot Study of Stereotactic Radiosurgery Combined With Nivolumab in Patients With Newly Diagnosed Melanoma Metastases in the Brain and Spine
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins2 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2016年6月23日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Incidence of serious adverse events (SAE) graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) version 4.0
研究概览
简要总结
This phase I pilot trial studies the side effects of stereotactic radiosurgery and nivolumab in treating patients with newly diagnosed melanoma that has spread to the brain or spine. Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor to more precisely target the cancer. Monoclonal antibodies, such as nivolumab may interfere with the ability of tumor cells to grow and spread. Giving stereotactic radiosurgery together with nivolumab may be a better treatment for melanoma.
详细描述
PRIMARY OBJECTIVES:
I. To assess the safety profile of stereotactic radiosurgery with nivolumab in combination to treat patients with newly diagnosed melanoma brain or spinal metastases.
SECONDARY OBJECTIVES:
I. To estimate local control rate in brain and spine. II. To estimate systematic control rate. III. To estimate progression-free survival.
TERTIARY OBJECTIVES:
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
- •Patients must have histologically confirmed diagnosis of melanoma; the pathologic confirmation may be from another metastatic site or from metastatic brain or spine lesions
- •Patients must have stage IV melanoma, with newly identified brain or spine metastases
- •Patients must have measurable lesion in the brain or spine that is >= 3 mm seen on magnetic resonance imaging (MRI) with contrast; NOTE: contrasted pre-treatment MRI scan must be obtained =< 21 days prior to stereotactic radiosurgery treatment
- •Karnofsky performance scale >= 70%
- •Leukocytes >= 3,000/mcL
- •Absolute neutrophil count >= 1,500/mcL
- •Platelets >= 100,000/mcL
- •Total bilirubin =< 2 x institutional upper limit of normal
- •Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/ alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal
- •Creatinine within normal institutional limits OR according to Johns Hopkins MRI policy
- •Women of child bearing potential (WOCBP) must use a reliable form of contraception during the study treatment period and for up to 12 weeks following the last dose of study drug
- •Men must agree to the use of male contraception during the study treatment period and for at least 12 weeks after the last dose of study drug
- •Ability to understand and the willingness to sign written informed consent document(s)
排除标准
- •Prior whole brain radiation or conventional radiation to the spine at the site of new lesion
- •Prior chemotherapy within 28 days of starting treatment
- •Prior therapy with investigational drugs within 28 days or at least 5 half-lives (whichever is longer) before study administration
- •Prior therapy with an anti- programmed cell death 1 (PD-1), anti- programmed cell death-ligand 1 (PD-L1), or anti-PDL-2 antibody
- •Neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
- •Known allergy to compounds of similar chemical or biologic composition to nivolumab
- •Pregnant or breastfeeding women
- •Known history of human immunodeficiency virus
- •Active infection requiring therapy, positive tests for hepatitis B surface antigen or hepatitis C ribonucleic acid (RNA)
- •Active autoimmune disease, history of autoimmune disease or history of syndrome that required systemic steroids or immunosuppressive medications, e.g. organ, tissue, or allogenic hematopoietic stem cell transplant (HSCT) recipients. Exceptions include those with vitiligo or resolved childhood asthma/atopy. Subjects with asthma who require intermittent use of bronchodilators (such as albuterol) will not be excluded from this study
- •Use of any live vaccines against infectious diseases up to 4 weeks (28 days) before receiving nivolumab. (NOTE: Inactivated seasonal influenza vaccines are permitted and do not require a 4-week waiting period before starting study treatment).
- •Prisoners or subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g. infectious disease) illness
- •Patients with both brain and spine metastases will be excluded from the trial
结局指标
主要结局
Incidence of serious adverse events (SAE) graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) version 4.0
时间窗: Up 12 weeks after first dose of study treatment
All SAEs will be tabulated by type and grade. Proportion of individual type of SAE event will be estimated using the binomial distribution along with 95% confidence interval (exact method).
次要结局
- Changes in the immune profile of peripheral blood during and after treatment with nivolumab in combination with stereotactic radiosurgery (immune response)(Baseline to up to 12 months)
- Incidence of toxicity graded according to the NCI CTC 4.0(Up to 30 days after completion of study treatment)
- Local control rate in brain defined as no change in number of lesions at initial treatment in the brain and change on size of targeted lesion is =< 25% from initial measurement(From date of initial nivolumab treatment to first date that progressive disease is objectively documented, assessed up to 3 years)
- Progression-free survival according to Response Evaluation Criteria in Solid Tumors criteria 1.1(From the date of initial diagnosis (at surgery) to the date of progressive disease was defined (documented), assessed up to 3 years)
- Systematic control rate in spine defined as no change in number of lesions at initial treatment in the spine and change on size of targeted lesion is =< 25% from initial measurement(Up to 3 years)
研究者
研究点 (2)
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