NCT03361865已完成3 期
A Phase 3 Randomized, Double-Blind Trial of Pembrolizumab (MK-3475) in Combination With Epacadostat (INCB024360) or Placebo in Participants With Cisplatin-ineligible Urothelial Carcinoma (KEYNOTE-672/ECHO-307)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 143
- 主要终点
- Objective Response Rate (ORR) With Pembrolizumab + Epacadostat Versus Pembrolizumab + Placebo
研究概览
简要总结
The purpose of this study was to evaluate the efficacy and safety of pembrolizumab + epacadostat vs pembrolizumab + placebo in participants with cisplatin-ineligible urothelial carcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
The study will be unblinded after the last participant completes Week 9 imaging assessment for efficacy analysis and after appropriate EC/IRB approvals have been received.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically-confirmed diagnosis of advanced/unresectable (inoperable) or metastatic urothelial cancer of the renal pelvis, ureter, bladder, or urethra.
- •Measurable disease based on RECIST v1.
- •Be considered ineligible to receive cisplatin-based combination therapy, based on protocol-defined criteria.
- •Have provided tissue for PD-L1 analysis from an archival tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated.
- •Have received no prior systemic chemotherapy for advanced/unresectable (inoperable) or metastatic urothelial cancer.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 within 14 days prior to randomization.
- •Adequate organ function per protocol-defined criteria.
排除标准
- •Disease that is suitable for local therapy administered with curative intent.
- •Known additional malignancy that is progressing or has required active treatment within the past 3 years.
- •Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, ie, without evidence of progression for at least 4 weeks by repeat imaging, clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.
- •Active autoimmune disease that has required systemic treatment in past 2 years.
- •Known history of human immunodeficiency virus (HIV) infection. HIV testing is not required unless mandated by local health authority.
- •Known history of or is positive for active hepatitis B (hepatitis B surface antigen [HBsAg] reactive) or has active hepatitis C (HCV RNA). Note: Testing must be performed to determine eligibility.
- •History of a gastrointestinal condition that in the opinion of the Investigator may affect oral drug absorption.
- •History or presence of an abnormal electrocardiogram (ECG) that, in the investigator's opinion, is clinically meaningful.
- •Use of protocol-defined prior/concomitant therapy.
研究组 & 干预措施
Pembrolizumab 200 mg + epacadostat 100 mg BID
Experimental
Pembrolizumab + epacadostat
干预措施: Pembrolizumab (Drug)
Pembrolizumab 200 mg + epacadostat 100 mg BID
Experimental
Pembrolizumab + epacadostat
干预措施: Epacadostat (Drug)
Pembrolizumab 200 mg + placebo BID
Active Comparator
Pembrolizumab + placebo
干预措施: Pembrolizumab (Drug)
Pembrolizumab 200 mg + placebo BID
Active Comparator
Pembrolizumab + placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Objective Response Rate (ORR) With Pembrolizumab + Epacadostat Versus Pembrolizumab + Placebo
时间窗: Week 9
ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 by investigator determination. Responses are based on Investigator assessments per RECIST 1.1 without confirmation using all scans up to the cutoff date.
次要结局
- Safety and Tolerability of Pembrolizumab + Epacadostat Versus Pembrolizumab + Placebo as Measured by Number of Participants Experiencing Adverse Events (AEs)(Up to approximately 25 months)
- Safety and Tolerability of Pembrolizumab + Epacadostat Versus Pembrolizumab + Placebo as Measured by Number of Participants Discontinuing Study Treatment Due to AE(Up to approximately 25 months)
研究者
研究点 (143)
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