NCT03068650No Longer Available不适用
Expanded Access (Compassionate Use) Treatment Protocol Rindopepimut (CDX-110)
适应症
试验速览
- 阶段
- 不适用
- 状态
- No Longer Available
研究概览
简要总结
Celldex endeavors to make investigational products available to patients with life-threatening diseases who have exhausted other treatment options and where there is a reasonable expectation of benefit over risk. Requests for expanded access to rindopepimut in patients with EGFRvlll expressing recurrent glioblastoma will be considered.
研究设计
- 研究类型
- Expanded Access
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
- •The patient has histologically confirmed relapsed or recurrent GBM.
- •EGFRvIII expression in tumor tissue, as assessed by a central laboratory using the Celldex assay.
- •Prior or planned therapy must include standard chemoradiation with temozolomide, unless the patient is not a candidate.
- •Systemic corticosteroid therapy tapered to less than 4 mg of dexamethasone (or equivalent) per day.
- •The patient does not have a known allergy or hypersensitivity to KLH, GM-CSF or yeast derived products, or a history of anaphylactic reactions to shellfish proteins.
- •The patient does not have abnormal organ function, active autoimmune disease, active infections or additional concurrent conditions that would compromise the patient's ability to safely receive rindopepimut vaccine therapy.
- •The patient is surgically sterile or post-menopausal, or, if of child-bearing potential, had a negative serum pregnancy test within the week prior to initiation of rindopepimut and is not nursing.
- •Males and females of childbearing potential must agree to practice an effective form of contraception during the time from signing of informed consent through 28 days after the last dose of rindopepimut.
- •The patient is able to read and understand, and has signed a patient informed consent form, which outlines the anticipated benefits and risks of treatment with rindopepimut.
排除标准
- 未提供
研究者
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