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雷莫芦单抗 (LY3009806) 加多西紫杉醇在尿路上皮癌患者中的研究 (RANGE)

2023年8月17日 更新者：Eli Lilly and Company

雷莫芦单抗加多西他赛与安慰剂加多西他赛在铂类治疗期间或之后进展的局部晚期或不可切除或转移性尿路上皮癌患者中进行的一项 3 期、随机、双盲、安慰剂对照研究

本研究的主要目的是评估研究药物雷莫芦单抗联合多西紫杉醇对既往铂类治疗失败的尿路上皮癌参与者的安全性和有效性。

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

530

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 丹麦
      • Herlev、丹麦、2730
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      • Odense、丹麦、5000
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  • 乌克兰
      • Dnipropetrovsk、乌克兰、49102
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Kyiv、乌克兰、04107
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Lutsk、乌克兰、63000
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  • 以色列
      • Haifa、以色列、3525408
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      • Kfar Saba、以色列、4428164
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      • Petach Tikva、以色列、4941492
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      • Tel Hashomer、以色列、5265601
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      • Tel-Aviv、以色列、6423906
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      • Zerifin、以色列、6093000
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  • 俄罗斯联邦
      • Ivanovo、俄罗斯联邦、153040
        • Ivanovo regional clinical oncology dispensary
      • Kazan、俄罗斯联邦、420029
        • Republic Oncology Dispensary of MoH of Republic Tatarstan
      • Moscow、俄罗斯联邦、125284
        • Scientific research oncology institute n.a. P. A. Herzen
      • Saint Petersburg、俄罗斯联邦、198255
        • Saint-Petersburg City Clinical Oncology Dispensary
      • Saratov、俄罗斯联邦、410054
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • 加拿大
      • Toronto、加拿大、M4N 3M5
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      • Vancouver、加拿大、V5Z 4E6
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  • 匈牙利
      • Budapest、匈牙利、1122
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      • Miskolc、匈牙利、3526
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  • 台湾
      • Kaohsiung、台湾、83301
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      • Taichung、台湾、40705
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      • Tainan、台湾、71004
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      • Taipei、台湾、100
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  • 墨西哥
      • Aguascalientes、墨西哥、20230
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      • Culiacan、墨西哥、80020
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      • Mexico、墨西哥、06760
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      • Monterrey、墨西哥、64570
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      • Morelia、墨西哥、58260
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  • 大韩民国
      • Daejeon、大韩民国、35015
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      • Seongnam、大韩民国、463-707
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      • Seongnam-si、大韩民国、13620
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      • Seoul、大韩民国、06351
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      • Seoul、大韩民国、05505
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      • Seoul、大韩民国、03722
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      • Seoul、大韩民国、03181
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  • 希腊
      • Athens、希腊、11528
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      • Heraklion、希腊、71110
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      • Patras、希腊、26504
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Thessaloniki、希腊、56403
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  • 德国
      • Dusseldorf、德国、40225
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      • Freiburg、德国、79106
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Homburg、德国、66421
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Jena、德国、07740
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      • Marburg、德国、35043
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Tubingen、德国、72076
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • 意大利
      • Arezzo、意大利、52100
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Bologna、意大利、40138
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      • Milano、意大利、20133
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      • Orbassano、意大利、10043
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Rome、意大利、00152
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      • Verona、意大利、37134
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  • 日本
      • Bunkyo-ku、日本、113-8431
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      • Chiba、日本、260-8717
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      • Fukuoka、日本、812-8582
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      • Hidaka、日本、350-1298
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Hirosaki、日本、036-8563
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      • Kashiwa、日本、277-8577
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      • Kita-gun、日本、761-0793
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      • Kobe、日本、650-0047
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      • Matsuyama、日本、791-0280
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      • Morioka、日本、020-8505
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      • Niigata、日本、951-8520
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      • Osaka、日本、541-8567
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      • Sapporo、日本、060-8543
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      • Sendai、日本、980-8574
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      • Suita-shi、日本、565-0871
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      • Tokyo、日本、135-8550
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      • Tsukuba、日本、305-8576
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  • 比利时
      • Brussels、比利时、1200
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      • Leuven、比利时、3000
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      • Wilrijk、比利时、2610
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  • 法国
      • Caen、法国、14076
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      • Lille、法国、59020
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      • Lyon、法国、69373
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      • Montpellier、法国、34070
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      • Paris、法国、75015
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      • Rennes、法国、35062
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  • 波兰
      • Gdansk、波兰、80-219
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      • Poznan、波兰、60-569
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      • Warszawa、波兰、04-125
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      • Wieliszew、波兰、05-135
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  • 澳大利亚
      • Adelaide、澳大利亚、5000
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      • Footscray、澳大利亚、3011
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      • Randwick、澳大利亚、2031
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      • Subiaco、澳大利亚、6008
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  • 火鸡
      • Ankara、火鸡、06100
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      • Antalya、火鸡、07059
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      • Edirne、火鸡、22030
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      • Istanbul、火鸡、34098
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
      • Malatya、火鸡、44280
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • 罗马尼亚
      • Baia Mare、罗马尼亚、430110
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Cluj-Napoca、罗马尼亚、400058
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Craiova、罗马尼亚、200347
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • 美国
    • Arkansas
      • Fayetteville、Arkansas、美国、72703
        • Highlands Oncology Group
    • California
      • Fullerton、California、美国、92835
        • St. Jude Medical Center
      • Los Angeles、California、美国、90024
        • UCLA Medical Center
      • Los Angeles、California、美国、90033
        • USC Norris Cancer Hospital
      • Los Angeles、California、美国、90095
        • SMO TRIO -Translational Research
      • Redondo Beach、California、美国、90277
        • Cancer Care Associates Medical Group
      • Sacramento、California、美国、95817
        • University of California, Davis - Health Systems
      • Santa Monica、California、美国、93454
        • Central Coast Medical Oncology Corporation
    • Colorado
      • Aurora、Colorado、美国、80045
        • University of Colorado
      • Denver、Colorado、美国、80203
        • Pharmatech Oncology Inc
      • Grand Junction、Colorado、美国、81501
        • St Mary's Hospital Regional Cancer Center
    • Connecticut
      • New Haven、Connecticut、美国、06520
        • Yale University School Of Medicine
    • Florida
      • Fort Lauderdale、Florida、美国、33308
        • Southeast Florida Hematology/Oncology
      • Fort Myers、Florida、美国、33916
        • Florida Cancer Specialists
      • Lakeland、Florida、美国、33805
        • Lakeland Regional Cancer Center
      • Miami、Florida、美国、33136
        • Sylvester Comprehensive Cancer Center
      • Saint Petersburg、Florida、美国、33705
        • Florida Cancer Specialists
    • Georgia
      • Newnan、Georgia、美国、30265
        • Southeastern Regional Medical Center
    • Hawaii
      • Honolulu、Hawaii、美国、96813
        • The Queen's Medical Center
    • Indiana
      • Fort Wayne、Indiana、美国、46845
        • Fort Wayne Oncology & Hematology
    • Louisiana
      • New Orleans、Louisiana、美国、70121
        • Alton Ochsner Medical Center
    • Maryland
      • Baltimore、Maryland、美国、21201
        • University of Maryland- Biological Sciences
    • Michigan
      • Detroit、Michigan、美国、48201
        • Karmanos Cancer Institute
    • Minnesota
      • Rochester、Minnesota、美国、55902
        • Mayo Clinic
    • Nebraska
      • Omaha、Nebraska、美国、68198-7680
        • University of Nebraska Medical Center
    • New York
      • New York、New York、美国、10021
        • Cornell University Medical College
      • Stony Brook、New York、美国、11794
        • SUNY at Stony Brook
    • Ohio
      • Cincinnati、Ohio、美国、45242
        • Oncology Hematology Care Inc.
    • Oklahoma
      • Oklahoma City、Oklahoma、美国、73104
        • University of Oklahoma Health Sciences Center
    • Tennessee
      • Nashville、Tennessee、美国、37203
        • SMO Sarah Cannon Research Inst.
    • Texas
      • Fort Worth、Texas、美国、76104
        • The Center for Cancer and Blood Disorders
    • Virginia
      • Fairfax、Virginia、美国、22031
        • Inova Comprehensive Cancer Care & Research Institute
    • Washington
      • Seattle、Washington、美国、98109
        • University of Washington Medical Center
  • 英国
      • Bebington、英国、CH63 4JY
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Chelsea、英国、W6 8RF
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
      • London、英国、EC1A 7BE
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Nottingham、英国、NG5 1PB
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Southampton、英国、SO16 6YD
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Sutton、英国、SM2 5PT
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • 荷兰
      • Amsterdam、荷兰、1066 CX
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Arnhem、荷兰、6815 AD
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Maastricht、荷兰、6229 HX
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Rotterdam、荷兰、3075 EA
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Sittard、荷兰、6162 BG
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • 西班牙
      • Badajoz、西班牙、06080
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Barcelona、西班牙、08907
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Madrid、西班牙、28034
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

描述

纳入标准：

  • 患有膀胱、尿道、输尿管或肾盂的经组织学或细胞学证实的局部晚期或不可切除或转移性尿路上皮（移行细胞）癌。
  • 在一线环境中使用含铂方案或完成一线铂方案后 14 个月内出现疾病进展。 接受一种免疫检查点抑制剂方案治疗的参与者符合条件（例如程序性死亡 1 (PD-1)、程序性死亡配体 1 (PDL1) 或 CTLA4），并且与之前的含铂治疗相比可能有更长的间隔（≤ 24 个月）。
  • 预期寿命≥3个月。
  • 在复发或转移的情况下接受过不超过一种先前的全身化疗方案。 允许使用不超过一种既往免疫检查点抑制剂的既往治疗，并且不会被视为全身化疗系列。
  • 患有实体瘤反应评估标准 1.1 版 (RECIST 1.1) 所定义的可测量疾病或不可测量但可评估疾病。
  • 东部肿瘤合作组 (ECOG) 为 0 或 1。
  • 具有足够的血液学功能。
  • 有足够的凝血功能。
  • 有足够的肝功能。

  • 参与者没有：

    • Child-Pugh B 级（或更差）的肝硬化
    • 肝硬化（任何程度）和肝硬化引起的肝性脑病或有临床意义的腹水病史
  • 具有足够的肾功能，如肌酐清除率 > 30 毫升/分钟所定义。
  • 试纸或常规尿液分析的尿蛋白≤1+。
  • 参与者愿意提供血液、尿液和组织样本用于研究目的。

排除标准：

  • 曾接受过一种以上的转移性疾病全身化疗方案。
  • 在任何情况下（新辅助、辅助、转移性）膀胱、尿道、输尿管或肾盂的移行细胞癌（TCC）接受过全身性紫杉烷治疗。
  • 曾接受过一种以上的抗血管生成药物（即贝伐珠单抗、索拉非尼、舒尼替尼）治疗尿路上皮 TCC。
  • 在随机分组前 4 周内（≤4 周）接受过放射治疗，或未从随机分组前 4 周以上给予的治疗的毒性作用中恢复。
  • 有不受控制的遗传性或获得性出血或血栓形成性疾病的病史。
  • 在随机分组前 3 个月内（​​≤3 个月）经历过 ≥3 级出血事件。
  • 有不受控制的并发疾病，包括但不限于症状性贫血、不受控制的高血压、有症状的充血性心力衰竭、不稳定型心绞痛、有症状或控制不佳的心律失常、精神疾病或任何其他严重的不受控制的医学疾病。
  • 在随机分组前 6 个月内（​​≤6 个月）经历过任何动脉或静脉血栓或血栓栓塞事件，包括但不限于心肌梗塞、短暂性脑缺血发作或脑血管意外。
  • 已知有未经治疗的脑转移、不受控制的脊髓压迫或软脑膜疾病。
  • 患有人类免疫缺陷病毒 (HIV) 感染或获得性免疫缺陷综合症相关疾病。
  • 在随机分组前 28 天（≤28 天）内接受过大手术或在随机分组前 7 天（≤7 天）内接受过皮下静脉通路装置植入。
  • 参与者在随机化或哺乳期之前怀孕。
  • 在研究入组后 5 年（≤5 年）内患有并发恶性肿瘤或患有另一种恶性肿瘤。

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：雷莫芦单抗+多西他赛
每个 21 天周期的第 1 天，静脉注射雷莫芦单抗（10 毫克/千克 [mg/kg]）加多西紫杉醇（75 毫克/平方米 [mg/m²]）静脉注射。 参与者可以继续接受治疗，直到满足停止标准。
药品：多西紫杉醇
管理 IV
药品：雷莫芦单抗
管理IV
其他名称：
  • LY3009806
安慰剂比较：安慰剂+多西他赛
每个 21 天周期的第 1 天静脉注射安慰剂 IV 加多西紫杉醇 (75 mg/m²)。 参与者可以继续接受治疗，直到满足停止标准。
药品：多西紫杉醇
管理 IV
药品：安慰剂
管理IV

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
无进展生存期 (PFS)
大体时间：随机化至放射学疾病进展或任何原因导致的死亡（长达 18 个月）
PFS 定义为从治疗第一天到根据实体瘤反应评估标准 (RECIST v1.1) 定义的疾病进展或任何原因死亡的第一个证据的时间。 疾病进展 (PD) 是指目标病灶的直径总和增加至少 20%，参考是研究中的最小总和加上至少 5 毫米的绝对增加，或非目标病灶的明确进展，或 1 个或更多新病灶。 如果参与者没有完成基线疾病评估，则 PFS 时间在首次给药之日截尾，无论参与者是否观察到客观确定的疾病进展或死亡。 如果截至分析的数据纳入截止日期不知道参与者已经死亡或有客观进展，则 PFS 时间在最后一个适当的肿瘤评估日期被审查。
随机化至放射学疾病进展或任何原因导致的死亡（长达 18 个月）

次要结果测量

结果测量
措施说明
大体时间
欧洲癌症研究与治疗组织生活质量问卷-核心 30 (EORTC QLQ-C30) 的生活质量 (QoL) 恶化时间 - 全球健康状况/QoL 量表
大体时间：随机化，治疗停止后 30 天（最多 18 个月）
持续恶化的时间定义为从随机化到 QoL 首次恶化且没有随后的非恶化评估的时间。 全球健康状况/QoL 的恶化定义为在 100 分制上下降≥10 分。 如果参与者没有报告恶化，持续恶化的时间在最后一次未恶化评估的日期被审查。 全球健康状况/QoL 评分范围为 0 至 100；更高的分数代表更好的 QoL。
随机化，治疗停止后 30 天（最多 18 个月）
EuroQol 5 维、5 级调查问卷 (EQ-5D-5L) 指数得分相对于基线的变化
大体时间：随机化，治疗停止后 30 天（最多 18 个月）
EQ-5D-5L 是一种标准化仪器，用于衡量自我报告的健康状况。 参与者完成了 5 级（无问题、轻微问题、中度问题、严重问题、无能力或极端问题）、5 维（行动能力、自我护理、日常活动、疼痛/不适和焦虑/抑郁）问卷他们目前的健康状况。 独特的 EQ-5D 健康状态是通过组合 5 个维度中每个维度的 1 个级别来定义的。 分数范围从 0（死亡）到 1（完美健康），但根据算法，分数 <0 是可能的。
随机化，治疗停止后 30 天（最多 18 个月）
总生存期 (OS)
大体时间：全因死亡日期的随机化（最长 31.1 个月）
OS 是从随机化日期到任何原因死亡日期的时间。 对于在特定分析的数据包含截止日期之前未知死亡的每位参与者，在数据包含截止日期之前的最后一个已知存活日期对该分析的 OS 进行了审查。
全因死亡日期的随机化（最长 31.1 个月）
具有客观缓解率 (ORR) 的参与者百分比
大体时间：疾病进展随机化（长达 29.7 个月）
ORR 定义为达到完全缓解 (CR) + 部分缓解 (PR) 最佳总体缓解的参与者的百分比。 ORR = CR + PR。 CR定义为所有靶病灶和非靶病灶消失。 任何病理性淋巴结（无论是目标淋巴结还是非目标淋巴结）的短轴必须减小至 < 10 毫米 (mm)。 肿瘤标志物结果必须已正常化。 PR 是目标病灶直径总和至少减少 30%，以基线直径总和为参考。 最佳总体反应是根据研究研究者根据 RECIST v1.1 评估的总体反应进行分类的。
疾病进展随机化（长达 29.7 个月）
具有疾病控制率 (DCR) 的参与者百分比
大体时间：疾病进展随机化（长达 29.7 个月）
DCR 是根据使用 RECIST v1.1 的反应，获得 CR、PR 或疾病稳定 (SD) 最佳总体反应的参与者的百分比。 目标病灶——CR：所有病灶消失；任何病理性淋巴结的短轴必须减少至<10 mm。 PR：病变直径总和与基线总和相比至少减少 30%。 疾病进展 (PD)：病变直径总和与研究中最小直径总和相比至少增加 20%（总和还必须证明绝对增加至少 5 毫米）；或出现新病变。 SD：既没有足够的收缩来满足 PR 的要求，也没有足够的增加来满足 PD 的要求。 非目标病灶——CR：所有病灶消失，肿瘤标志物水平正常化；所有淋巴结的大小必须是非病理性的。 非 CR/非 PD：病变持续存在和/或异常肿瘤标志物水平维持。 PD：现有病变的明确进展或新病变的出现。
疾病进展随机化（长达 29.7 个月）
响应持续时间 (DoR)
大体时间：完全缓解 (CR) 或部分缓解 (PR) 日期至客观疾病进展或因任何原因死亡的日期（最长 28.4 个月）
如果他们具有 CR 或 PR 的最佳总体反应，则达到了客观反应。 目标病灶-CR：所有病灶消失；任何病理性淋巴结的短轴缩短至<10 mm。 PR：病变直径总和与基线总和相比至少减少 30%。 PD：病灶直径总和与研究中最小直径总和相比至少增加 20%（总和还必须证明绝对增加至少 5 毫米）；或出现新病变。 非目标病灶——CR：所有病灶消失，肿瘤标志物水平正常化；所有淋巴结的大小必须是非病理性的。 非 CR/非 PD：病变持续存在和/或异常肿瘤标志物水平维持。 PD：现有病变的明确进展或新病变的出现。 如果截至数据纳入截止日期，参与者尚未死亡或未通过放射学记录 PD，则 DOR 在最后一次充分肿瘤评估之日进行审查。
完全缓解 (CR) 或部分缓解 (PR) 日期至客观疾病进展或因任何原因死亡的日期（最长 28.4 个月）
EuroQol 5 维、5 级问卷 (EQ-5D-5L) 视觉模拟量表 (VAS) 基线的变化
大体时间：随机化，停止治疗后 30 天（最长 18 个月）
EQ-5D-5L 是一种标准化仪器，用于衡量自我报告的健康状况。 独特的 EQ-5D 健康状态是通过结合 5 个维度中每个维度的 1 个级别来定义的。 参与者通过在 VAS 上打分来表示他们当前的健康状况，评分范围从 100（可想象的最佳健康状态）到 0（可想象的最差健康状态）。
随机化，停止治疗后 30 天（最长 18 个月）
药代动力学 (PK)：雷莫芦单抗的最大浓度 (Cmax)
大体时间：第 1 周期和第 9 周期，第 1 天：给药前、给药后
雷莫芦单抗输注结束时雷莫芦单抗的 Cmax。
第 1 周期和第 9 周期，第 1 天：给药前、给药后
PK：雷莫芦单抗的最低浓度 (Cmin)
大体时间：第 2、3、5 和 9 个周期的第 1 天（给药前和给药后）
每 3 周给药一次后雷莫芦单抗的 Cmin。
第 2、3、5 和 9 个周期的第 1 天（给药前和给药后）
具有抗雷莫芦单抗抗体的参与者数量
大体时间：29.7 个月
按治疗组总结了治疗出现阳性抗雷莫芦单抗抗体的参与者人数。
29.7 个月

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

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Eli Lilly and Company

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  • 研究主任：Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)、Eli Lilly and Company

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2015年7月13日

初级完成 (实际的)

2017年4月21日

研究完成 (实际的)

2022年7月26日

研究注册日期

首次提交

2015年4月21日

首先提交符合 QC 标准的

2015年4月21日

首次发布 (估计的)

2015年4月24日

研究记录更新

最后更新发布 (实际的)

2023年8月21日

上次提交的符合 QC 标准的更新

2023年8月17日

最后验证

2023年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 15679
  • I4T-MC-JVDC (其他标识符：Eli Lilly and Company)
  • 2014-003655-66 (EudraCT编号)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

在批准研究计划和签署数据共享协议后，将在安全访问环境中提供匿名的个人患者级别数据。

IPD 共享时间框架

在美国和欧盟研究的适应症首次公布和批准后 6 个月（以较晚者为准）可提供数据。 数据将无限期地可供请求。

IPD 共享访问标准

研究提案必须得到独立审查小组的批准，研究人员必须签署数据共享协议。

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 企业社会责任

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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