EUCTR2014-004026-17-GB进行中（未招募）1 期
A Phase II Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) in Subjects with High Risk Non-muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guerin (BCG) Therapy - Pembrolizumab (MK3457) in high risk NMIBC patients unresponsive to BCG
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc0 个研究点目标入组 260 人开始时间: 2016年2月9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
- 260
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
- •1. Have a histologically-confirmed diagnosis of high risk non-muscle-invasive (T1, High Grade Ta and/or CIS) transitional cell carcinoma of the bladder.
- •2. In subjects who have papillary tumors (Ta and T1), a complete TURBT must have been performed, as characterized by:
- •- Attainment of a visually complete resection of all papillary tumors (Ta and T1)
- •- Residual CIS not amenable to complete transurethral resection is acceptable
- •- The most recent cystoscopy / TURBT must have been performed within 12 weeks of the first dose of trial treatment.
- •3. Have been treated with adequate BCG therapy and have developed high risk NMIBC that is unresponsive to BCG therapy.
- •4. Have elected not to undergo, or are considered ineligible for radical cystectomy, as determined by the treating surgeon.
- •5. Have provided tissue for biomarker analysis from the most recent cystoscopy/TURBT procedures from which tumor sample is available.
- •6. Have a performance status of 0, 1 or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale. (Max of 5% ECOG of 2.)
- •7. Demonstrate adequate organ function.
- •8. Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication and be willing to use contraception in accordance with the Protocol.
- •Are the trial subjects under 18?
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 86
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 174
排除标准
- •1. Has muscle invasive (i.e. T2, T3, T4) locally advanced non-resectable or metastatic urothelial carcinoma.
- •2. Has concurrent extra-vesical (i.e. urethra, ureter or renal pelvis) non-muscle invasive transitional cell carcinoma of the urothelium.
- •3. Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
- •4. Has undergone any intervening intravesical chemotherapy or immunotherapy from the time of most recent cystoscopy/TURBT to starting trial treatment.
- •5. Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to Cycle 1, Day 1 or who has not recovered (ie, = Grade 1 or at baseline) from adverse events due to a previously administered agent.
- •6. Has a known additional malignancy that has had progression or has required active treatment in the last three years
- •7. Has an active autoimmune disease that has required systemic treatment in past 2 years.
- •8. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the planned first dose of the study. The use of physiologic doses of corticosteroids may be approved after consultation with the Sponsor.
- •9. Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis
- •10. Has an active infection requiring systemic therapy, including active or intractable urinary tract infection (UTI) in the last month.
- •11. Is pregnant or breastfeeding, or expecting to conceive within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment.
- •12. Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2 agent, or with an agent directed to another co-inhibitory T-cell receptor (e.g. CTLA-4, OX-40, CD137).
- •13. Has a known history of Human Immunodeficiency Virus (HIV) (HIV-1/2 antibodies).
- •14. Has known active Hepatitis B or Hepatitis C.
- •15. Has received a live virus vaccine within 30 days of planned start of trial treatment.
- •16. Has had an allogeneic tissue/solid organ transplant.
研究者
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