NCT03595228已完成2 期
A Phase 2 Trial of BN-Brachyury and Radiation Therapy in Patients With Advanced Chordoma
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 10
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
The goal of this study is to determine if the combination of BN-Brachyury plus radiation therapy can induce objective radiographic response rate (ORR) in patients, using a Simon 2-stage optimal design. In stage 1, a minimum of threshold of activity is needed to proceed to stage 2.
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
- 12 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have histologically confirmed chordoma
- •Patients must have measurable disease by RECIST 1.1
- •Patients must be scheduled to have radiation therapy to at least 1 target lesion.
- •Age ≥12 years
- •Patients must have normal organ and marrow function
- •Must have recovered completely from any reversible toxicity associated with recent therapy.
- •There should be a minimum of 2 weeks from any chemotherapy, small molecule/targeted therapy, immunotherapy and/or radiation prior to enrolment
- •Females of childbearing potential and male partners of Females of childbearing potential must agree to use effective birth control or abstinence from screening to after the last vaccination therapy
排除标准
- •Concurrent treatment for cancer, with specific exceptions noted in the inclusion criteria
- •Chronic hepatitis B or C infection.
- •Any significant disease, that in the opinion of the investigator may impair the patient's tolerance of trial treatment.
- •Significant dementia, altered mental status, or any psychiatric condition that would prohibit the understanding, or rendering of informed consent.
- •Active autoimmune diseases requiring treatment or a history of autoimmune disease that might be stimulated by vaccine treatment. This requirement is due to the potential risks of exacerbating autoimmunity.
- •Concurrent use of systemic steroids, except for physiological doses of systemic steroid replacement or local steroid use.
- •Patients who are receiving any other investigational agents within 28 days before start of trial treatment.
- •History of allergic reactions attributed to compounds of similar chemical or biological composition to MVA-BN/FPV-Brachyury or other agents used in trial. History of allergic reactions to aminoglycoside antibiotic or egg products.
- •Serious or uncontrolled intercurrent illness, included but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with trial requirements.
- •Pregnant women are excluded from this trial due to the unknown effects of the BN-Brachyury on the fetus or infant.
- •HIV-positive patients are ineligible because of the potential for decreased immune response to the vaccine.
- •Significant cardiovascular disease, which includes but is not limited to New York Heart Association Heart Failure Class II or greater, myocardial infarction within the previous 3 months, unstable arrhythmias, unstable angina.
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: Within 12 months post-completion of radiation on target lesion(s) based on modified RECIST v1.1
Rate of subjects achieving a best response of either Complete Response or Partial Response per modified RECIST v1.1. A modified RECIST v1.1 assessment is based on targeted radiated lesion(s). Progression of a non-target lesion does not result in disease progression by the modified RECIST evaluation for this trial. Assessment for targeted radiated lesion(s): Complete Response (CR)=Disappearance of all target radiated lesions; Partial Response (PR)= \>=30% decrease in the sum of the longest diameter of target radiated lesions; Progressive Disease (PD) = \>=20% increase in the sum of the longest diameter of target radiated lesions, Stable Disease (SD)=-30%\<sum of the longest diameter of target radiated lesions\<20%.
次要结局
- Progression-free Survival (PFS)(Time from the day of first treatment to the start of disease progression or death, whichever occurs first up to 30 days after last tumor assessment visit. Data were collected up to 29 months.)
- Baseline and Overall Treatment Period Change From Baseline Brief Pain Improvement-Short Form Best Observed Scores(Overall Treatment Period: The time from the day of first treatment to the last scheduled trial visit, approximately 30 days after the last treatment visit. Data were collected up to 29 months.)
- Baseline and Overall Treatment Period Change From Baseline Brief Pain Improvement-Short Form Worst Observed Scores(Overall Treatment Period: The time from the day of first treatment to the last scheduled trial visit, approximately 30 days after the last treatment visit. Data were collected up to 29 months.)
研究者
研究点 (10)
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