NL-OMON35662已完成不适用
A phase I-II open label clinical trial, evaluating the efficacy and safety of administration of the therapeutic vaccine PEP-223/CoVaccine HT, to hormone treatment naive, immunocompetent subjects with T1-3, N0-1/x, M0 prostate cancer, eligible for hormone therapy. - PEP223-NL-701
Pepscan Therapeutics B.V.0 个研究点目标入组 12 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1 pathological confirmed prostatic adenocarcinoma, clinical
- •stage (c) cT1-3, cN0-1/x, cM0;
- •2 baseline testosterone levels of > 4 nmol/l;
- •3 baseline PSA level of > 10 µg/l;
- •4 eligible for hormone therapy;
- •5 willingness to comply with the protocol conditions and procedures;
- •6 willing and able to give informed consent.
排除标准
- •1 clinical evidence of distant metastases;
- •2 previous (within 3 years before enrolment into the present study)hormonal therapy administered specifically for prostatic carcinoma;
- •3 development of another invasive neoplastic disease during the previous 5 years, or concomitant presence of another invasive neoplastic disease, except basal cell carcinoma or squamous cell carcinoma of the skin;
- •4 primary or secondary immunodeficiency, including immunosuppressive disease or use of corticosteroids or other immunosuppressive medications;
- •5 concomitant administration -or administration during the 12 weeks preceding study inclusion- of immune enhancing medication or testosterone supplements;
- •6 presence of bacterial prostatitis causing a PSA increase during the 8 weeks preceding study inclusion;
- •7 simultaneous participation in another clinical trial or participation in a clinical trial involving investigational drugs within 3 months before enrolment into the present study;
- •8 BMI > 30 kg/m2;
- •9 a previous serious reaction to a vaccine such as angioedema or anaphylaxis.
研究者
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