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临床试验/NCT02674061
NCT02674061已完成2 期

A Phase II, Open-label, Single-arm, Multicenter Study to Evaluate Efficacy and Safety of Pembrolizumab Monotherapy in Subjects With Advanced Recurrent Ovarian Cancer (KEYNOTE-100)

Merck Sharp & Dohme LLC0 个研究点目标入组 376 人开始时间: 2016年2月25日最近更新:
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适应症

试验速览

阶段
2 期
状态
已完成
入组人数
376
主要终点
ORR Per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants With Programmed Cell Death Ligand -1 (PD-L1) Combined Positive Score (CPS) ≥10
研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

This study will assess the efficacy and safety of pembrolizumab (MK-3475) monotherapy in female participants with recurrent ovarian cancer (ROC) who have received up to 5 prior lines of treatment including platinum-based treatment for ROC (1 to 6 total prior lines counting front line therapy). Participants will be enrolled into two separate cohorts based on the number of prior lines of treatment received for ROC. There will be no hypothesis testing in this study.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —（Adult, Older Adult）
性别
Female
接受健康志愿者
否

入选标准

  • •Has histologically confirmed epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer
  • •Has received a front line platinum-based regimen (administered via either intravenous or intraperitoneal route) per local standard of care or treatment guideline following the primary or interval debulking surgery with documented disease recurrence (note: Maintenance treatment following the front line treatment is permitted and counted together as part of the front line treatment)
  • •Has fulfilled the following additional requirements regarding prior treatments for ROC depending on the cohort participant is to be enrolled. Each participant must have documented evidence of clinical response or disease stabilization to the last regimen received.
  • •Cohort A: Has received 0 to 2 additional prior lines for treating ROC (or 1-3 total prior lines counting the front line) and must have a platinum-free interval (PFI) of ≥ 3 to 12 months if the last regimen received is a platinum-based, or a treatment-free interval (TFI) of ≥ 3 to 12 months if the last regimen received is a non-platinum-based
  • •Cohort B: Has received 3 to 5 additional prior lines for treating ROC (or 4-6 total prior lines counting the front line) and must have a PFI of ≥ 3 months if the last regimen received is a platinum-based, or a TFI of ≥ 3 months if the last regimen received is a non-platinum-based
  • •Has measurable disease at baseline based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as determined by the central imaging vendor
  • •Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • •Has a life expectancy of ≥16 weeks
  • •Has provided a tumor tissue sample either collected from prior cytoreductive surgery or fresh newly obtained tumor tissue at screening
  • •Has adequate organ function
  • •Female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study drug

排除标准

  • •Is currently participating in or has participated in a clinical study and received an investigational agent or used an investigational device within 4 weeks prior to the first dose of study treatment
  • •Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
  • •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
  • •Has had prior anti-cancer monoclonal antibody (mAb), chemotherapy, targeted small molecule therapy, or radiation therapy within 4 weeks prior to the planned first dose of the study
  • •Has not recovered from AEs to ≤ Grade 1 or prior treatment level due to a previously administered agent
  • •Has epithelial ovarian cancer (EOC) with mucinous histology subtype
  • •Has a known additional malignancy that progressed or required active treatment within the last 5 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
  • •Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they have stable brain metastases
  • •Has known history of, or any evidence of active, non-infectious pneumonitis
  • •Has an active infection requiring systemic therapy
  • •Has symptoms of bowel obstruction in the past 3 months
  • •Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study
  • •Is pregnant or breastfeeding, or expecting to conceive children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study drug
  • •Has received prior therapy with an anti-programmed cell death (PD)-1, anti-PD-L1, anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated antigen-4 [CTLA-4], tumor necrosis factor receptors OX-40 or CD137) or has participated in prior pembrolizumab (MK-3475) studies
  • •Has a known history of Human Immunodeficiency Virus (HIV)
  • •Has known active Hepatitis B or Hepatitis C
  • •Has received a live vaccine within 30 days of the planned first dose of the study

结局指标

主要结局

ORR Per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants With Programmed Cell Death Ligand -1 (PD-L1) Combined Positive Score (CPS) ≥10

时间窗: Up to ~43 months (through database cut-off date of 18-September-2019)

ORR was defined as the percentage of participants in the analysis population who had a CR (Disappearance of all target lesions) or a PR (≥30% decrease in SOD of target lesions) using RECIST 1.1 based on BICR. ORR was analyzed by test of binomial parameter. The percentage of participants who experienced CR or PR per RECIST 1.1 by BICR is reported here as the ORR for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by immunohistochemistry (IHC) as CPS ≥10.

Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in All Cohort A and Cohort B Participants

时间窗: Up to ~43 months (through database cut-off date of 18-September-2019)

ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters \[SOD\] of target lesions) using RECIST 1.1 based on BICR. ORR was analyzed by test of binomial parameter. The percentage of participants who experienced CR or PR per RECIST 1.1 by BICR is reported for all participants in Cohort A and Cohort B.

ORR Per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥1

时间窗: Up to ~43 months (through database cut-off date of 18-September-2019)

ORR was defined as the percentage of participants in the analysis population who had a CR (Disappearance of all target lesions) or a PR (≥30% decrease in SOD of target lesions) using RECIST 1.1 based on BICR. ORR was analyzed by test of binomial parameter. The percentage of participants who experienced CR or PR per RECIST 1.1 by BICR is reported here as the ORR for the subgroup of participants in Cohort A and Cohort B who had a PD-L1 biomarker positive expression defined by immunohistochemistry (IHC) as CPS ≥1.

次要结局

  • Percentage of Participants With PFS (PFS Rate) at Month 18 Per RECIST 1.1 by BICR in All Cohort A and Cohort B Participants(Month 18)
  • Percentage of Participants With PFS (PFS Rate) at Month 18 Per RECIST 1.1 by Investigator in All Cohort A and Cohort B Participants(Month 18)
  • Percentage of Participants With PFS (PFS Rate) at Month 6 Per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥10(Month 6)
  • Percentage of Participants With PFS (PFS Rate) at Month 6 Per RECIST 1.1 by BICR in Subgroup of Cohort A Participants With PFI/TFI ≥3-6 Months(Month 6)
  • DCR Per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥10(Up to ~43 months (through database cut-off date of 18-September-2019))
  • Progression Free Survival (PFS) Per RECIST 1.1 by BICR in All Cohort A and Cohort B Participants(Up to ~58.8 months (through database cut-off date of 18-March-2021))
  • Duration of Response (DOR) Per RECIST 1.1 by BICR in All Cohort A and Cohort B Participants(Up to ~43 months (through database cut-off date of 18-September-2019))
  • DOR Per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥10(Up to ~43 months (through database cut-off date of 18-September-2019))
  • Percentage of Participants With PFS (PFS Rate) at Month 6 Per RECIST 1.1 by BICR in All Cohort A and Cohort B Participants(Month 6)
  • Percentage of Participants With PFS (PFS Rate) at Month 18 Per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥1(Month 18)
  • DOR Per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥1(Up to ~43 months (through database cut-off date of 18-September-2019))
  • Disease Control Rate (DCR) Per RECIST 1.1 by BICR in All Cohort A and Cohort B Participants(Up to ~43 months (through database cut-off date of 18-September-2019))
  • Percentage of Participants With PFS (PFS Rate) at Month 18 Per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥10(Month 18)
  • Percentage of Participants With PFS (PFS Rate) at Month 12 Per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥1(Month 12)
  • ORR Per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥1(Up to ~43 months (through database cut-off date of 18-September-2019))
  • DCR Per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥1(Up to ~43 months (through database cut-off date of 18-September-2019))
  • PFS Per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥10(Up to ~43 months (through database cut-off date of 18-September-2019))
  • ORR Per RECIST 1.1 by Investigator in All Cohort A and Cohort B Participants(Up to ~43 months (through database cut-off date of 18-September-2019))
  • ORR Per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥10(Up to ~43 months (through database cut-off date of 18-September-2019))
  • DCR Per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥1(Up to ~43 months (through database cut-off date of 18-September-2019))
  • PFS Per RECIST 1.1 by Investigator in All Cohort A and Cohort B Participants(Up to ~43 months (through database cut-off date of 18-September-2019))
  • Percentage of Participants With PFS (PFS Rate) at Month 12 Per RECIST 1.1 by BICR in All Cohort A and Cohort B Participants(Month 12)
  • Percentage of Participants With PFS (PFS Rate) at Month 6 Per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥10(Month 6)
  • Percentage of Participants With PFS (PFS Rate) at Month 12 Per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥10(Month 12)
  • PFS Per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥1(Up to ~43 months (through database cut-off date of 18-September-2019))
  • Percentage of Participants With PFS (PFS Rate) at Month 6 Per RECIST 1.1 by BICR in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥1(Month 6)
  • DOR Per RECIST 1.1 by Investigator in All Cohort A and Cohort B Participants(Up to ~43 months (through database cut-off date of 18-September-2019))
  • DOR Per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥10(Up to ~43 months (through database cut-off date of 18-September-2019))
  • DCR Per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥10(Up to ~43 months (through database cut-off date of 18-September-2019))
  • DOR Per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥1(Up to ~43 months (through database cut-off date of 18-September-2019))
  • Percentage of Participants With PFS (PFS Rate) at Month 6 Per RECIST 1.1 by Investigator in All Cohort A and Cohort B Participants(Month 6)
  • Percentage of Participants With PFS (PFS Rate) at Month 12 Per RECIST 1.1 by Investigator in All Cohort A and Cohort B Participants(Month 12)
  • Percentage of Participants With PFS (PFS Rate) at Month 18 Per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥1(Month 18)
  • PFS Per RECIST 1.1 by BICR in Subgroup of Cohort A Participants With PFI/TFI ≥3-6 Months(Up to ~43 months (through database cut-off date of 18-September-2019))
  • DOR Per RECIST 1.1 by BICR in Subgroup of Cohort A Participants With PFI/TFI ≥3-6 Months(Up to ~43 months (through database cut-off date of 18-September-2019))
  • DCR Per RECIST 1.1 by Investigator in All Cohort A and Cohort B Participants(Up to ~43 months (through database cut-off date of 18-September-2019))
  • Percentage of Participants With PFS (PFS Rate) at Month 12 Per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥10(Month 12)
  • ORR Per RECIST 1.1 by BICR in Subgroup of Cohort A Participants With Platinum-Free Interval (PFI)/Treatment-Free Interval (TFI) ≥3-6 Months(Up to ~43 months (through database cut-off date of 18-September-2019))
  • ORR Per RECIST 1.1 by BICR in Subgroup of Cohort A Participants With PFI/ TFI >6-12 Months(Up to ~43 months (through database cut-off date of 18-September-2019))
  • Percentage of Participants With PFS (PFS Rate) at Month 12 Per RECIST 1.1 by BICR in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months(Month 12)
  • PFS Per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥10(Up to ~43 months (through database cut-off date of 18-September-2019))
  • Percentage of Participants With PFS (PFS Rate) at Month 12 Per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥1(Month 12)
  • DOR Per RECIST 1.1 by BICR in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months(Up to ~43 months (through database cut-off date of 18-September-2019))
  • ORR Per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants With PFI/ TFI ≥3-6 Months(Up to ~43 months (through database cut-off date of 18-September-2019))
  • DOR Per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants With PFI/TFI ≥3-6 Months(Up to ~43 months (through database cut-off date of 18-September-2019))
  • DOR Per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months(Up to ~43 months (through database cut-off date of 18-September-2019))
  • Percentage of Participants With PFS (PFS Rate) at Month 18 Per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants With PFI/TFI ≥3-6 Months(Month 18)
  • Percentage of Participants With PFS (PFS Rate) at Month 18 Per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥10(Month 18)
  • PFS Per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥1(Up to ~43 months (through database cut-off date of 18-September-2019))
  • Percentage of Participants With PFS (PFS Rate) at Month 6 Per RECIST 1.1 by Investigator in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥1(Month 6)
  • DCR Per RECIST 1.1 by BICR in Subgroup of Cohort A Participants With PFI/TFI ≥3-6 Months(Up to ~43 months (through database cut-off date of 18-September-2019))
  • DCR Per RECIST 1.1 by BICR in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months(Up to ~43 months (through database cut-off date of 18-September-2019))
  • Percentage of Participants With PFS (PFS Rate) at Month 6 Per RECIST 1.1 by BICR in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months(Month 6)
  • Percentage of Participants With PFS (PFS Rate) at Month 12 Per RECIST 1.1 by BICR in Subgroup of Cohort A Participants With PFI/TFI ≥3-6 Months(Month 12)
  • Percentage of Participants With PFS (PFS Rate) at Month 18 Per RECIST 1.1 by BICR in Subgroup of Cohort A Participants With PFI/TFI ≥3-6 Months(Month 18)
  • PFS Per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months(Up to ~43 months (through database cut-off date of 18-September-2019))
  • Overall Survival (OS) in All Cohort A and Cohort B Participants(Up to ~58.8 months (through database cut-off date of 18-March-2021))
  • Percentage of Participants With OS (OS Rate) at Month 18 in All Cohort A and Cohort B Participants(Month 18)
  • OS in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥10(Up to ~43 months (through database cut-off date of 18-September-2019))
  • Percentage of Participants With OS (OS Rate) at Month 18 in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥1(Month 18)
  • PFS Per RECIST 1.1 by BICR in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months(Up to ~43 months (through database cut-off date of 18-September-2019))
  • Percentage of Participants With PFS (PFS Rate) at Month 18 Per RECIST 1.1 by BICR in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months(Month 18)
  • Percentage of Participants With PFS (PFS Rate) at Month 12 Per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants With PFI/TFI ≥3-6 Months(Month 12)
  • Percentage of Participants With OS (OS Rate) at Month 6 in All Cohort A and Cohort B Participants(Month 6)
  • Percentage of Participants With OS (OS Rate) at Month 6 in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥10(Month 6)
  • Percentage of Participants With OS (OS Rate) at Month 18 in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥10(Month 18)
  • Percentage of Participants With OS (OS Rate) at Month 12 in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥1(Month 12)
  • Percentage of Participants With OS (OS Rate) at Month 6 in Subgroup of Cohort A Participants With PFI/TFI ≥3-6 Months(Month 6)
  • ORR Per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants With PFI/ TFI >6-12 Months(Up to ~43 months (through database cut-off date of 18-September-2019))
  • DCR Per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants With PFI/TFI ≥3-6 Months(Up to ~43 months (through database cut-off date of 18-September-2019))
  • DCR Per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months(Up to ~43 months (through database cut-off date of 18-September-2019))
  • PFS Per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants With PFI/TFI ≥3-6 Months(Up to ~43 months (through database cut-off date of 18-September-2019))
  • Percentage of Participants With PFS (PFS Rate) at Month 6 Per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants With PFI/TFI ≥3-6 Months(Month 6)
  • Percentage of Participants With PFS (PFS Rate) at Month 12 Per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months(Month 12)
  • Percentage of Participants With PFS (PFS Rate) at Month 18 Per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months(Month 18)
  • OS in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥1(Up to ~43 months (through database cut-off date of 18-September-2019))
  • Number of Participants Who Experienced an Adverse Event (AE)(Up to ~58.8 months (through database cut-off date of 18-March-2021))
  • Percentage of Participants With PFS (PFS Rate) at Month 6 Per RECIST 1.1 by Investigator in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months(Month 6)
  • Percentage of Participants With OS (OS Rate) at Month 12 in All Cohort A and Cohort B Participants(Month 12)
  • Percentage of Participants With OS (OS Rate) at Month 24 in All Cohort A and Cohort B Participants(Month 24)
  • Percentage of Participants With OS (OS Rate) at Month 6 in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥1(Month 6)
  • Percentage of Participants With OS (OS Rate) at Month 12 in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months(Month 12)
  • Percentage of Participants With OS (OS Rate) at Month 12 in Subgroup of Cohort A and Cohort B Participants With PD-L1 CPS ≥10(Month 12)
  • Percentage of Participants With OS (OS Rate) at Month 6 in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months(Month 6)
  • Percentage of Participants With OS (OS Rate) at Month 18 in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months(Month 18)
  • OS in Subgroup of Cohort A Participants With PFI/TFI ≥3-6 Months(Up to ~43 months (through database cut-off date of 18-September-2019))
  • Percentage of Participants With OS (OS Rate) at Month 12 in Subgroup of Cohort A Participants With PFI/TFI ≥3-6 Months(Month 12)
  • OS in Subgroup of Cohort A Participants With PFI/TFI >6-12 Months(Up to ~43 months (through database cut-off date of 18-September-2019))
  • Percentage of Participants With OS (OS Rate) at Month 18 in Subgroup of Cohort A Participants With PFI/TFI ≥3-6 Months(Month 18)
  • Number of Participants Who Discontinued Study Treatment Due to an AE(Up to ~58.8 months (through database cut-off date of 18-March-2021))

研究者

申办方类型
Industry
责任方
Sponsor

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