PER-045-18尚未招募未知
A PHASE 3, RANDOMIZED, COMPARATOR-CONTROLLED CLINICAL TRIAL TO STUDY THE EFFICACY AND SAFETY OF PEMBROLIZUMAB (MK-3475) IN COMBINATION WITH BACILLUS CALMETTE-GUERIN (BCG) IN PARTICIPANTS WITH HIGH-RISK NON-MUSCLE INVASIVE BLADDER CANCER (HR NMIBC) THAT IS PERSISTENT OR RECURRENT FOLLOWING BCG INDUCTION (KEYNOTE-676)
Merck Sharp & Dohme Corp., una subsidiaria de Mer·ck & Co. Inc.,0 个研究点目标入组 0 人开始时间: 2019年1月16日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
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
入选标准
- •1. Male/female participants who are at least 18 years of age
- •2. Have histologically confirmed by BICR diagnosis of non-muscle invasive (T1, highgrade Ta and/or CIS) transitional cell carcinoma (TCC) of the bladder.
- •3. Have been treated with one adequate course of BCG induction therapy for the treatment of High-risk Non-muscle Invasive Bladder Cancer (HR NMIBC)
- •4. Following adequate BCG induction therapy, must have persistent or recurrent HR NMIBC
- •5.Have undergone cystoscopy/TURBT to remove all resectable disease within 12 weeks prior to randomization
- •6.Have provided tissue for biomarker analysis from the most recent TURBT/biopsy procedures from which tumor sample is available.
- •7.Have a performance status of 0, 1 or 2 on the ECOG Performance Scale, as assessed within 14 days prior to randomization.
- •8.Have adequate organ function within 14 days prior to randomization.
- •9. Participant is:
- •- a female that is not pregnant, not breastfeeding, and is either not of childbearing potential (WOCBP) OR is a WOCBP who agrees to follow the contraceptive guidance per protocol during the treatment period and through 120 days after the last dose of study treatment or
- •- a male that agrees to follow the contraceptive guidance per protocol during the treatment period and through 120 days after the last dose of study treatment
- •10.The participant (or legally acceptable representative if applicable) provides written informed consent for the study.
排除标准
- •1. Has persistent (remains present within 3 months (-2 weeks) to 6 months (+4 weeks) after start of BCG induction) T1 disease following an induction course of BCG.
- •2. Has muscle invasive (ie, T2, T3, T4), locally advanced non-resectable or metastatic urothelial carcinoma
- •3. Has concurrent extra-vesical (ie, urethra, ureter, renal pelvis) non-muscle invasive transitional cell carcinoma of the urothelium, concurrent upper tract involvement, or invasive prostatic TCC including T1 or greater disease, or ductal invasion.
- •4.A WOCBP who has a positive urine pregnancy test within 72 hours prior to randomization.
- •5.Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor
- •6.Has received prior systemic anti-cancer within 4 weeks of start of study treatment.
- •7.Has received prior radiotherapy within 2 weeks of start of study treatment..
- •8.Has received a live vaccine within 30 days of start of study treatment.
- •9. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days of start of study treatment.
- •10. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
- •11. Has an active autoimmune disease that has required systemic treatment in past 2 years
- •12. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
- •13. Has one or more of the following contraindications to BCG: prior BCG sepsis or systemic infection, total bladder incontinence, or an adverse experience to a previous
- •BCG instillation that resulted in treatment discontinuation and precludes retreating with BCG.
- •14. Has an active infection requiring systemic therapy (including a symptomatic UTI).
- •15. Has a known history of HIV infection, Hepatitis B or known active Hepatitis C virus or has evidence of active tuberculosis
研究者
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