NCT05153304撤回1 期
A Phase I/II Study of Personalized Immunotherapy in Adults With Upper Gastrointestinal Tract Cancers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Quantitative frequency of TCR
研究概览
简要总结
The purpose of this study is to determine if it is possible to make and safely administer a 'personalized' cancer vaccine for people diagnosed with an upper gastrointestinal tract cancer.
详细描述
The purpose of this study is to determine if it is possible to make and safely administer a 'personalized' cancer vaccine for people diagnosed with an upper gastrointestinal tract cancer.
It is known that cancer has mutations (changes in genetic material) that are specific to an individual person and their tumor. These mutations can cause the tumor cells to produce proteins that are different from the body's normal, healthy cells. The study will use a sample of your tumor to create a vaccine against it, with the idea being that the study vaccine will "teach" the body's immune system to recognize and attack the cancer cells. The study will examine the safety of the study vaccine when given at several time points and will examine your blood for signs that the study vaccine causes the immune system to respond.
The personalized cancer vaccine will be given alone or in combination with nivolumab. Nivolumab is a drug that blocks certain proteins on cells that help to keep immune responses in check. In a healthy person, this keeps the immune system from attacking healthy cells and tissues, but cancer cells use these proteins to keep the immune system from killing cancer cells and tumors. When these proteins are blocked, the check on the immune system is removed and immune cells may be able to recognize and kill cancer cells.
This personalized cancer vaccine is considered experimental because it is not approved by the US Food & Drug Administration (FDA) as a treatment for cancer.
The combination of nivolumab and the personalized cancer vaccine is experimental and is not FDA approved.
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
- •Histologically or cytologically documented gastroespohageal or gastric adenocarcinoma.
- •Measurable disease as defined by RECIST 1.1
- •Adequate organ function
- •Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence)
排除标准
- •Currently receiving or has received another anti-cancer therapy within 4 weeks prior to first dose of vaccine study treatment.
- •Currently receiving or has received PD1/PDL1 inhibitor immunotherapy within 4 weeks prior to first dose of study treatment.
- •Received an investigational agent within 28 days prior to the first dose of study drug.
- •Untreated brain metastases; individuals with treated and stable metastases are eligible. Eligible subjects should have recovered from the acute effects of radiation therapy or surgery prior to study entry, have discontinued corticosteroid treatment for brain metastases for at least 4 weeks and are neurologically stable for 8 weeks (confirmed by MRI) prior to administration of experimental therapy
- •Has known history of Human Immunodeficiency Virus (HIV).
- •Received a diagnosis of hepatitis B or hepatitis C for which there is no clear evidence of natural immunity, immunity subsequent to vaccination, or successful eradication of the virus following antiviral therapy (individuals who are hepatitis C antibody positive may be enrolled if negative viral load confirmed).
- •History of autoimmune disease including: inflammatory bowel disease (including ulcerative colitis and Crohn's Disease), rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythematosus, autoimmune vasculitis (e.g. Wegener's granulomatosis); central nervous system or motor neuropathy considered of autoimmune origin (e.g. Guillain-Barré syndrome, myasthenia gravis, multiple sclerosis). Individuals with vitiligo, Sjogren's Syndrome, interstitial cystitis, Graves' or Hashimoto's Disease, celiac disease, DM1, or hypothyroidism stable on hormone replacement will be allowed with Study Medical Monitor's approval.
- •Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
- •History of receiving a solid organ transplant or allogeneic bone marrow transplant.
- •Major surgical procedure within 28 days prior to the first dose of study drug.
- •If female, pregnant or breastfeeding.
研究组 & 干预措施
anti-PD1 and personalized vaccine
Experimental
干预措施: personalized vaccine (Biological)
anti-PD1 and personalized vaccine
Experimental
干预措施: Nivolumab (Drug)
结局指标
主要结局
Quantitative frequency of TCR
时间窗: 1 year
Treatment-related Adverse Events
时间窗: 1 year
次要结局
- Duration of response(1 year)
- Progression-free survival (PFS)(1 year)
- Overall Response(1 year)
- Overall Survival(1 year)
研究者
Ezra Cohen
Physician
University of California, San Diego
研究点 (1)
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