EUCTR2011-000948-18-DE进行中（未招募）不适用
Phase I/IIa study of immunization with a p16INK4a peptide combined with MONTANIDE ISA-51 VG in patients with advanced HPV-associated cancers - Immune therapy of HPV-induced cancers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Histologically confirmed, advanced HPV-positive cancers of entities and stages as defined in the following listing under progression, regression or with stable disease (and still incurable) after standard therapy or after refusal of standard therapy as defined in the following listing or with contraindications for standard treatment
- •HPV positivity
- •Diffuse expression of p16INK4a in the tumor
- •Expected survival of at least six months.
- •Full recovery from surgery, chemo therapy or radiation therapy.
- •ECOG performance status 0, 1 or 2.
- •adequate blood and biochemistry parameters
- •Male or female* patients = 18 years old
- •Patient´s written informed consent for participation in the trial
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Prior treatment with P16_37-63 peptide
- •Clinically significant heart disease (NYHA Class III or IV).
- •Other serious illnesses, eg, serious infections requiring antibiotics or bleeding disorders.
- •History of immunodeficiency disease or autoimmune disease.
- •Metastatic disease to the central nervous system for which other therapeutic options, including radiotherapy, may be available.
- •HBV, HCV or HIV positivity.
- •Chemotherapy, any type of radiation therapy, or immunotherapy within 4 weeks before study entry
- •Concomitant treatment with steroids, antihistaminic drugs, or nonsteroidal anti-inflammatory drugs (unless used in low doses for prevention of an acute cardiovascular event or for pain control). Topical or inhalational steroids are permitted.
- •Participation in any other clinical trial involving another investigational agent within 4 weeks.
- •Pregnancy or lactation.
- •Women of childbearing potential who are not using a medically acceptable means of contraception.
- •Psychiatric or addictive disorders that may compromise the ability to give informed consent.
- •Lack of availability of a patient for immunological and clinical follow-up assessment.
- •Brain metastases (symptomatic and non-symptomatic)
研究者
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