EUCTR2015-003644-40-IT进行中（未招募）1 期
Phase II Trial of Pembrolizumab (MK-3475) in Subjects with Metastatic Castration-Resistant Prostate Cancer (mCRPC) - Phase II Trial of MK-3475 in Subjects with mCRPC
MERCK SHARP & DOHME CORP. UNA SUSSIDIARIA DI MERCK & CO. INC.0 个研究点目标入组 370 人开始时间: 2021年1月5日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 370
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
- Male
入选标准
- •1. Be willing and able to provide written informed consent for the trial. The subject may also provide consent for Future Biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical Research.
- •2. Be =18 years of age on day of signing informed consent.
- •3. Have histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology. Diagnosis must be stated in a pathology report and confirmed by the Investigator.
- •4.Have RECIST 1.1-measurable prostate cancer on computed tomography (CT) or magnetic resonance imaging (MRI) scans (Cohorts 1, 2, and 4) or detectable bone metastases by whole body bone scintigraphy and no RECIST 1.1 -measurable tumors
- •(Cohorts 3 and 5), as determined by central review. Disease must be either metastatic or locally confined inoperable disease that cannot be treated with definitive intent.
- •5. Have supplied tumor tissue from either a newly obtained biopsy or an archival specimen
- •from a site not previously irradiated (tumors progressing in a prior site of radiation are
- •allowed for PD-L1 characterization; other exceptions may be considered after Sponsor
- •consultation). Adequacy of these specimens for PD-L1 biomarker analysis will be required by a central laboratory prior to enrollment. Subjects in Cohorts 1, 2, and 4 with visceral/measurable lesions must provide a newly obtained biopsy performed after the
- •last line of systemic therapy where safely available or alternatively an archival specimen, if available. Subjects in Cohort 3 must provide an archival specimen.
- •For Cohorts 1, 2, and 3 only:
- •6. Have been treated with:
- •a. At least one targeted endocrine therapy (defined as second generation antiandrogen therapies that include but are not limited to abiraterone acetate with prednisone, enzalutamide, and next generation targeted agents such as ARN-509).
- •b. At least one regimen / line of chemotherapy that contained docetaxel.
- •c. No more than two chemotherapy regimens.
- •d. No more than three regimens / lines of the aforementioned treatments ( having failed/progressed on chemotherapy and targeted endocrine therapy).
- •For Cohorts 4 and 5 only:
- •7. Failing or showing signs of failure on current pre-chemotherapy enzalutamide treatment
- •as defined by PCWG3 guidelines. Subjects can have failed prior abiraterone treatment before current enzalutamide treatment. Subjects must have had a clinically meaningful response to enzalutamide treatment.
- •For Cohorts 1, 2, 3, 4, and 5:
- •8. Have ongoing androgen deprivation with total serum testosterone < 50 ng/dL (< 2.0 nM). If the subject is currently being treated with LHRH agonists (subjects who have not undergone an orchiectomy), this therapy must have been initiated at least 4 weeks prior to first dose of trial treatment. This treatment must be continued throughout the study.
- •9. Subjects receiving bone resorptive therapy (including but not limited to bisphosphonate or RANK-L inhibitor) must have been on stable doses for = 4 weeks prior to first dose of trial treatment.
- •10. Have a performance status of 0, 1 or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
- •11. Male subjects of reproductive potential must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.
- •12. Demonstrate adequate organ function as defined in protocol
- •13. Demonstrate adequate organ function as defined in protocol
排除标准
- •1.Is currently participating and receiv study ther or has particip in a study of an investigat agent and received study ther or used an investigation device within4weeks of the first dose of trial treatm
- •2Has a diagnosis of immunodeficiency or is receiving systemic steroid ther or any other form of immunosuppressive ther within 7 days prior to the first dose of trial treatment. The use of physiologic doses of corticosteroids may be approved after consultation with the Sponsor (replacement ther for adrenal insufficiency is permitted).
- •3Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to the first dose of trial treatment or who has not recovered (=Grade 1 or at baseline) from adverse events due to mAbs administered more than 4 weeks earlier.
- •4Has had prior chemother, targeted small molecule ther, or external beam radiation ther within 4 weeks prior to the first dose of trial treatment or who has not recovered (=Grade 1 or baseline) from adverse events due to a previously administered agent. Treatment with Radium223 is allowed as long as the last dose has been administered no less than4weeks prior to the first dose.
- •5Has a known additional malignancy that has had progression or has required active treatment in the last 3 years. Exceptions include basal cell carcinoma of the skin and squamous cell carcinoma of the skin that has undergone potentially curative ther or in situ cervical cancer.
- •6Has known active central nervous system (CNS) metastases and/or carcinomatous
- •meningitis. Subjects with previously treated brain metastases may participate
- •provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to the first dose of trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.
- •7Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement ther (e.g., thyroxine, insulin, or physiologic corticosteroid replacement ther for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- •8Has evidence of interstitial lung disease and/or a history of (noninfectious) pneumonitis that required steroids, or current pneumonitis.
- •9Has an active infection requiring systemic ther.
- •10Has history or current evidence of any condition, ther, 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 treating Investigator.
- •11Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- •12. Has previously participated in any other pembrolizumab (MK-3475) trial, or received prior ther with an anti-PD-1, anti-PD-L1, and anti-PD-L2 (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
- •13Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
- •14Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
研究者
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