Phase Ib/II Trial of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (mCRPC) (KEYNOTE-365) - MK3475-365

Farmaceutische Industrie0 个研究点目标入组 8 人开始时间: 待定最近更新: 2024年9月9日

适应症

试验速览

阶段: 2 期
状态: 招募中
发起方
入组人数: 8

研究概览入排标准研究者记录与标识符相似试验

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 64（—）

入选标准

•The below-mentioned inclusion criteria are the most important ones. A complete
•list of cohort specific inclusion criteria can be found in the protocol. - Be
•willing and able to provide documentad written informed consent/assent for the
•trial - Be >= 18 years of age on day of signing informed consent - Have
•histologically- or cytologically-confirmed adenocarcinoma of the prostate
•without small cell histology (cohorts A-E, G, J) - Have t-NE prostate cancer
•defined by >=1% neuroendocrine cells in a recent biopsy specimen from a
•metastasis - Have provided tumor tissue from a site not previously irradiated -
•Have prostate cancer progression within 6 months prior to screening - Have
•progression if the subject received anti-androgen therapy prior to enrollment -
•Have ongoing androgen deprivation with serum testosterone <50 ng/dl -
•Subjects receiving bone resorptive therapy must have been on stable doses for
•>=4 weeks prior to first dose of trial treatment - Agree to use an adequate
•method of contraception, if the subject is of reproductive potential, starting
•with the first dose of study therapy through 120 days after the last dose of
•study therapy - Demonstrate adequate organ function

排除标准

•The below-mentioned exclusion criteria are the most important ones. A complete
•list of cohort specific exclusion criteria can be found in the protocol.
•- Has had prior anticancer mAb within 4 weeks prior to first dose of trial
•treatment of who has not recovered form AEs due to mAbs administered more than
•4 weeks prior to first dose of trial treatment
•- Is currently participating in and receiving study therapy or has participated
•in a study of an investigational device within 4 weeks of randomization
•- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy
•or any other form of immunosuppressive therapy within 7 days of randomization
•- If a subject has undergone major surgery, they must have recovered adequately
•from the toxicities/complications prior to starting therapy
•- Has had a prior radium treatment or treatment with other therapeutic
•radiopharmaceuticals for prostate cancer
•- Has a known additional malignancy that has had progression or has required
•active treatment in the last 3 years
•- Has an active autoimmune disease that has requires systemic treatment in past
•- Has a history of (non-infectious) pneumonitis/interstitial lung disease that
•steroids or current pneumonitis/interstitial lung disease.
•- Has an active infection requiring systemic therapy
•- has a history or current evidence of any condition, therapy, or laboratory
•abnormality that might confound the results of the trial, interfere with the
•subject's participation for the full duration of the trial, or is not in the
•best interest of the subject to participate, in the opinion of the investigator
•- has known psychiatric or substance abuse disorder that would interfere with
•cooperation with the requirements of the trial
•- Has previously participated in any other pembrolizumab trials, or received
•prior therapy with an anti-PD-1, anti-PD-L1 and anti-PD-L2
•- Has known history of HIV
•- Has known active hepatitis B, or C virus
•- Has received a live vaccine within 30 days of the first dose of trial
•- Has used herbal products that may have hormonal anti-prostate cancer activity
•and/or are known to decrease PSA levels within 4 weeks prior to randomization
•- Has known active central nervous system metastases and/or carcinomatous
•- Has had prior chemotherapy, targeted small molecule therapy, abiraterone
•acetate treatment, enzalutamide treatment, or radiation therapy within 2 weeks
•prior to first dose of trial treatment or who has not recovered from AEs due to
•previously administered agent
•- Has a superscan bone scan
•- Has had prior solid, organ or bone marrow transplant

研究者

发起方

Farmaceutische Industrie

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