EUCTR2014-004026-17-GR进行中（未招募）1 期
A Phase II Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) and Pembrolizumab in Combination with Other Investigational Agents in Subjects with High risk Non-muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guerin (BCG) Therapy - Pembrolizumab (MK-3475) in high risk NMIBC patients unresponsive to BCG
Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc0 个研究点目标入组 320 人开始时间: 2016年5月12日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 320
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 resection is
- •-The most recent cystoscopy/TURBT must have been performed within 12 weeks of randomization
- •-For Cohort C: subjects with T1 disease should have undergone a
- •restaging TURBT procedure within 12 weeks prior to randomization to
- •confirm complete resection.
- •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.)(for
- •cohorts A and B only)
- •7.Have adequate organ function.
- •8.A female participant is eligible if not pregnant or breastfeeding, and at
- •least one of the following applies:
- •- Is not a WOCBP; or
- •- Is a WOCBP and using a contraceptive method as described in the
- •protocol. A WOCBP must have a negative pregnancy test as described in
- •the protocol
- •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 106
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 214
排除标准
- •1.Has centrally-assessed muscle invasive (i.e. T2, T3, T4) locally advanced non-resectable or metastatic urothelial carcinoma.
- •2.Has centrally-assessed 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 is progressing or requires active treatment.
- •7.7. Has present or progressive accumulation of pleural, ascitic, or
- •pericardial fluid requiring drainage or diuretic drugs within 2 weeks
- •before randomization/study allocation for Cohort C.
- •8. Has severe hypersensitivity to pembrolizumab (all cohorts), MK-
- •7684A (Cohort C arm 1), MK-4280A (Cohort C Arm 2), and/or any of
- •their excipients.
- •Has an active autoimmune disease that has required systemic
- •treatment in past 2 years.
- •10. Has a diagnosis of immunodeficiency or is receiving chronic systemic
- •steroid therapy (in dosing exceeding 10 mg daily of prednisone
- •equivalent) or any other form of immunosuppressive therapy within 7
- •days prior to the first dose of the study intervention. The use of
- •physiologic doses of corticosteroids may be approved after consultation
- •with the Sponsor
- •11.Has a history of (non-infectious) pneumonitis /or interstitial lung
- •disease that required steroids or has current pneumonitis
- •12.Has an active infection requiring systemic therapy, including active or intractable (UTI) in the last month.
- •13. 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, or is not in the best interest of
- •the subject to participate, in the opinion of the investigator.
- •14. Has a known psychiatric or substance abuse disorder that would
- •interfere with the participant's ability to cooperate with the
- •requirements of the trial.
- •15.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.
- •16.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).
- •17.Has received previous treatment with another agent targeting the
- •TIGIT and/or LAG3 receptor pathway (Cohort C only).
- •18.Has a known history of Human Immunodeficiency Virus (HIV) (HIV-
- •1/2 antibodies).
- •19.Has known active Hepatitis B or Hepatitis C.
- •20.Has received a live virus vaccine within 30 days of planned start of trial treatment.
- •21. Has had an allogeneic tissue/solid organ transplant.
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