A Study of Atezolizumab in Advanced Solid Tumors
2021年5月11日 更新者：Hoffmann-La Roche
An Open-Label, Multicohort, Phase II Study of Atezolizumab in Advanced Solid Tumors
The primary efficacy objective for this study is to evaluate non-progression rate (NPR) at 18 weeks in participants with advanced solid tumors treated with atezolizumab, defined as the percentage of participants with complete response (CR), partial response (PR), or stable disease (SD) as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1, or according to disease-specific criteria for prostate cancer and malignant pleural mesothelioma.
研究概览
地位
完全的
条件
研究类型
介入性
注册 (实际的)
474
阶段
- 阶段2
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
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Aarhus N、丹麦、8200
- Aarhus Universitetshospital; Kræftafdelingen
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Herlev、丹麦、2730
- Herlev Hospital; Afdeling for Kræftbehandling
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Odense C、丹麦、5000
- Odense Universitetshospital, Onkologisk Afdeling, Klinisk Forsknings Enhed
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Moscow、俄罗斯联邦、115478
- Russian Oncology Research Center n.a. N.N. Blokhin Dpt of Clinical Pharmacology and Chemotherapy
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Saint-Petersburg、俄罗斯联邦、197758
- S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)
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British Columbia
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Vancouver、British Columbia、加拿大、V5Z 4E6
- BCCA-Vancouver Cancer Centre
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Ontario
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Toronto、Ontario、加拿大、M5G 2M9
- University Health Network; Princess Margaret Hospital; Medical Oncology Dept
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Graz、奥地利、8036
- LKH-UNIV. KLINIKUM GRAZ; Klinische Abteilung für Onkologie
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Wien、奥地利、1090
- Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Chemotherapie & Infektionskrankhei
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RJ
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Rio de Janeiro、RJ、巴西、20231-050
- INCA 1- Instituto Nacional de Câncer X
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RS
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Porto Alegre、RS、巴西、90035-903
- Hospital das Clinicas - UFRGS
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SP
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Sao Paulo、SP、巴西、01246-000
- Instituto do Cancer do Estado de Sao Paulo - ICESP
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Hamburg、德国、20246
- Uniklinik-Eppendorf; Zentren F. Innere Medizin-Klinik U. Poliklinik
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Heidelberg、德国、69120
- Universitatsklinik Heidelberg; Universitätshautklinik und Nationales Centrum für Tumorerkrankungen
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Trier、德国、54290
- Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie
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Campania
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Napoli、Campania、意大利、80131
- Istituto Nazionale Tumori Fondazione G. Pascale
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Lombardia
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Milano、Lombardia、意大利、20133
- Fondazione IRCCS Istituto Nazionale dei Tumori
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Toscana
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Siena、Toscana、意大利、53100
- Azienda Ospedaliera Universitaria Senese, U.O.C. Immunoterapia Oncologica
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Bergen、挪威、5021
- Haukeland Universitetssjukehus; Klinisk forskningspost
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Oslo、挪威、0310
- Oslo Universitetssykehus HF; Radiumhospitalet
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Bordeaux、法国、33076
- Institut Bergonié
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Lyon、法国、69373
- Centre Leon Berard; Departement Oncologie Medicale
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Paris、法国、75475
- Hopital Saint Louis, Service D Oncologie Medicale
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Villejuif、法国、94805
- Institut Gustave Roussy
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Bydgoszcz、波兰、85-796
- Centrum Onkologii w Bydgoszczy
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Gdańsk、波兰、80-214
- Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii
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Warszawa、波兰、02-781
- Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie; Klinika Now. Tkanek Miekkich,Kosci i Czer.
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Edirne、火鸡、22030
- Trakya University Medical Faculty
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Istanbul、火鸡、34300
- Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology
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Istanbul、火鸡、34384
- Prof. Dr. Cemil Tascioglu City Hospital; Med Onc
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Sihhiye/Ankara、火鸡、06230
- Hacettepe Uni Medical Faculty Hospital; Oncology Dept
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Dublin、爱尔兰、4
- St Vincent'S Uni Hospital; Medical Oncology
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Dublin、爱尔兰
- St James' Hospital; Cancer Clinical Trials Office
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Fribourg、瑞士、1708
- Freiburger Spital; Onkologie
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St. Gallen、瑞士、9007
- Kantonsspital St. Gallen; Onkologie/Hämatologie
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New York
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New York、New York、美国、10027
- Columbia University Medical Center
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New York、New York、美国、10065
- Memorial Sloan Kettering
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Ohio
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Cleveland、Ohio、美国、44195
- The Cleveland Clinic Foundation
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Tennessee
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Nashville、Tennessee、美国、37203
- Sarah Cannon Cancer Center and Research Institute
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Texas
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Houston、Texas、美国、77030
- MD Anderson Cancer Center
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Helsinki、芬兰、00029
- Helsinki University Central Hospital; Dept of Oncology
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Bebington、英国、CH63 4JY
- Clatterbridge Cancer Centre
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Southampton、英国、SO16 6YD
- Southampton General Hospital; Medical Oncology
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Amsterdam、荷兰、1066 CX
- Antoni van Leeuwenhoek Ziekenhuis
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Rotterdam、荷兰、3015 GD
- Erasmus MC
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Utrecht、荷兰、3584 CX
- Universitair Medisch Centrum Utrecht
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Barcelona、西班牙、08035
- Hospital Univ Vall d'Hebron; Servicio de Oncologia
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Navarra
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Pamplona、Navarra、西班牙、31008
- Clinica Universitaria de Navarra; Servicio de Oncologia
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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
有资格学习的性别
全部
描述
Inclusion Criteria:
- Histologically documented advanced solid tumors that meet protocol-defined cohort specifications, have progressive disease at study entry, and have received at least one line of prior systemic therapy or for which no alternative therapy to prolong survival exists
- Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens in paraffin blocks (preferred) or in freshly cut and unstained slides (exceptional cases) with an associated pathology report for central testing
- Measurable disease as defined by RECIST v1.1 or disease-specific criteria for prostate cancer and malignant pleural mesothelioma
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Negative serum pregnancy test result within 14 days prior to study drug among women of childbearing potential
- Life expectancy > 3 months
Exclusion Criteria:
- Malignancies other than disease under study within 5 years prior to Day 1 of Cycle 1 except those with a negligible risk of metastasis or death
- Uncontrolled tumor-related pain
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures >/=1 time per month
- History of asymptomatic or symptomatic central nervous system (CNS) metastasis
- Leptomeningeal disease
- Spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated but without evidence that disease has been clinically stable for >/=2 weeks prior to Day 1 of Cycle 1
- Pregnant and lactating women
- Significant cardiovascular disease within 3 months prior to Day 1 of Cycle 1
- Severe infection within 4 weeks prior to Day 1 of Cycle 1
- Oral or IV antibiotics within 2 weeks prior to Day 1 of Cycle 1
- History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
- Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or to any component of the atezolizumab formulation
- History of autoimmune disease except treated/stable hypothyroidism, Type 1 diabetes mellitus, and protocol-specified dermatologic conditions
- Active tuberculosis
- Signs or symptoms of infection within 2 weeks prior to Day 1 of Cycle 1
- Prior treatment with cluster of differentiation (CD) 137 agonists or immune checkpoint blockade therapies, or anti-programmed cell death-1 (PD-1) or anti-PD-L1 therapeutic antibodies
- Treatment with systemic corticosteroids or other systemic immunosuppressive medications within 2 weeks prior to Day 1 of Cycle 1, or anticipated requirement for systemic immunosuppressive medications during the trial
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：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Atezolizumab
The dose of atezolizumab in this study will be 1200 milligrams (mg) administered by intravenous (IV) infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity.
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Atezolizumab will be given as IV infusion over 60 minutes on Day 1 of Cycle 1, then over 30 minutes (as tolerated) on Day 1 of each subsequent 3-week cycle.
其他名称：
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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 |
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Non-progression Rate (NPR) at 18 Weeks
大体时间：At Week 18
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NPR was defined as the percentage of participants with complete response (CR), partial response (PR) or stable disease (SD) as assessed by the Investigator according to Response Evaluation Criteria in Solid Tumors (RECIST), v1.1 or for malignant pleural mesothelioma according to Malignant Pleural Mesothelioma Response Evaluation Criteria.
CR: Disappearance of all target lesions.
PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions in the absence of CR.
SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD).
PD: At least a 20% increase in the sum of diameters of all target and all new measurable lesions.
For prostate cancer according to Prostate Response Evaluation Criteria.
CR: PSA <5 ng/ml measured twice at least 3 weeks apart or PSA response: PSA < 50% of the PSA reference value occurring at any time after treatment was initiated.
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At Week 18
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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NPR at 24 Weeks
大体时间：At Week 24
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NPR was defined as the percentage of participants with complete response (CR), partial response (PR) or stable disease (SD) as assessed by the Investigator according to Response Evaluation Criteria in Solid Tumors (RECIST), v1.1 or for malignant pleural mesothelioma according to Malignant Pleural Mesothelioma Response Evaluation Criteria.
CR: Disappearance of all target lesions.
PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions in the absence of CR.
SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD).
PD: At least a 20% increase in the sum of diameters of all target and all new measurable lesions.
For prostate cancer according to Prostate Response Evaluation Criteria.
CR: PSA <5 ng/ml measured twice at least 3 weeks apart or PSA response: PSA < 50% of the PSA reference value occurring at any time after treatment was initiated.
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At Week 24
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Overall Response Rate (ORR)
大体时间：Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first)
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ORR was defined as the percentage of participants with CR or PR as assessed by the investigator using RECIST v1.1 or Malignant Pleural Mesothelioma Response Evaluation Criteria.
CR: Disappearance of all target lesions.
PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR.
For prostate cancer according to Prostate Response Evaluation Criteria.
CR: PSA <5 ng/ml measured twice at least 3 weeks apart or PSA response: PSA < 50% of the PSA reference value occurring at any time after treatment was initiated.
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Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first)
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Percentage of Participants by Best Overall Response (BOR)
大体时间：Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first)
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BOR was based on RECIST v1.1, Malignant Pleural Mesothelioma Response Evaluation Criteria or Prostate Response Evaluation Criteria.
For an individual participant BOR was obtained as follows: 1) CR: overall tumor response assessment of CR at 2 consecutive visits at least 28 days apart.
2) PR: overall tumor response assessment of PR or CR at 2 consecutive visits at least 28 days apart without being a CR. 3) SD: overall tumor response assessment of SD, PR, or CR at one or more visits at least 42 days after start of study treatment, but was not a confirmed CR or PR. 4) PD: an overall tumor response assessment of PD at any visit, and did not meet the criteria for a BOR of CR, PR or SD. 5) Missing: an assessment of SD, PR or CR in the first 42 days after start of study treatment and no further tumor assessments thereafter.
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Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first)
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Clinical Benefit Rate (CBR)
大体时间：Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first)
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CBR was defined as the percentage of participants with CR, PR, or SD according to RECIST v1.1, Malignant Pleural Mesothelioma Response Evaluation Criteria or Prostate Response Evaluation Criteria lasting for >/=6 weeks.
CR: Disappearance of all target lesions.
PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions in the absence of CR.
SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD).
PD: At least a 20% increase in the sum of diameters of all target and all new measurable lesions.
For prostate cancer: CR: PSA <5 ng/ml measured twice at least 3 weeks apart or PSA response: PSA < 50% of the PSA reference value occurring at any time after treatment was initiated.
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Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first)
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Duration of Objective Response (DOR)
大体时间：Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first)
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DOR, based on RECIST v1.1, was defined as the time from the first occurrence of a documented objective response (CR or PR) to the time of progression or death from any cause, whichever occurred first.
CR: Disappearance of all target lesions.
PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions in the absence of CR.
PD: At least a 20% increase in the sum of diameters of all target and all new measurable lesions.
As pre-specified in the Statistical Analysis Plan (SAP) DOR was not analyzed if there were less than 4 participants available for the analysis.
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Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first)
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Progression-Free Survival (PFS)
大体时间：Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first)
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PFS, based on RECIST v1.1, was defined as the time from the first day of study treatment to the first occurrence of disease progression or death from any cause, whichever occurred first.
PD: At least a 20% increase in the sum of diameters of all target and all new measurable lesions.
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Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first)
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Time to Progression (TTP)
大体时间：Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first)
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Time to progression (TTP), based on RECIST v1.1, was defined as time from the first day of study treatment to the first occurrence of progressive disease or death due to disease progression, whichever occurred first.
PD: At least a 20% increase in the sum of diameters of all target and all new measurable lesions.
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Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first)
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Overall Survival (OS)
大体时间：Baseline until death due to any cause (up to 4.5 years)
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OS was defined as the time from the first day of study treatment to death from any cause.
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Baseline until death due to any cause (up to 4.5 years)
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Number of Participants With Adverse Events
大体时间：Baseline up to 4.5 years
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An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment.
An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product.
Preexisting conditions which worsen during a study are also considered as adverse events.
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Baseline up to 4.5 years
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Treatment Duration of Atezolizumab
大体时间：Baseline up to approximately 4.5 years
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Baseline up to approximately 4.5 years
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Mean Number of Doses of Atezolizumab
大体时间：Baseline up to approximately 4.5 years
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Baseline up to approximately 4.5 years
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Percentage of Participants With Anti-drug Antibodies (ADAs) to Atezolizumab
大体时间：Baseline up to 4.5 years
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Baseline up to 4.5 years
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Serum Concentration of Atezolizumab
大体时间：Predose and postdose on Day 1 of Cycle 1, predose on Day 1 of Cycles 2, 3, 4, 8 (cycle length = 21 days), and every 8 cycles until treatment discontinuation; at follow up (approximately 120 days after last dose) up to approximately 4.5 years
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Predose and postdose on Day 1 of Cycle 1, predose on Day 1 of Cycles 2, 3, 4, 8 (cycle length = 21 days), and every 8 cycles until treatment discontinuation; at follow up (approximately 120 days after last dose) up to approximately 4.5 years
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Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR)
大体时间：Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first)
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Modified RECIST was based on the following: 1) New measurable lesions were added into the total tumor burden and followed; 2) Non-target lesions contributed only in the assessment of a CR; 3) Radiographic progression was determined only on the basis of measurable disease; had to be confirmed by a consecutive assessment =/>4 weeks from the date first documented.
mBOR: 1) CR: overall tumor response assessment of CR at 2 consecutive visits at least 28 days apart.
2) PR: overall tumor response assessment of PR/CR at 2 consecutive visits at least 28 days apart without being a CR. 3) SD: overall tumor response assessment of SD/PR/CR at one or more visits at least 42 days after start of study treatment, but was not a confirmed CR or PR. 4) PD: an overall tumor response assessment of PD at any visit, and did not meet the criteria for a BOR of CR, PR or SD. 5) Missing: an assessment of SD, PR or CR in the first 42 days after start of study treatment and no further tumor assessments thereafter.
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Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first)
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ORR Based on Modified RECIST v1.1
大体时间：Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first)
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Modified RECIST was based on the following: 1) New measurable lesions were added into the total tumor burden and followed; 2) Non-target lesions contributed only in the assessment of a CR; 3) Radiographic progression was determined only on the basis of measurable disease; had to be confirmed by a consecutive assessment =/>4 weeks from the date first documented.
ORR was defined as the percentage of participants with CR or PR.
CR: Disappearance of all target lesions.
PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR.
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Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first)
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CBR Based on Modified RECIST v1.1
大体时间：Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first)
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Modified RECIST was based on the following: 1) New measurable lesions were added into the total tumor burden and followed; 2) Non-target lesions contributed only in the assessment of a CR; 3) Radiographic progression was determined only on the basis of measurable disease; had to be confirmed by a consecutive assessment =/>4 weeks from the date first documented.
CBR was defined as the percentage of participants with CR, PR, or SD lasting for >/=6 weeks.
CR: Disappearance of all target lesions.
PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions in the absence of CR.
SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD).
PD: At least a 20% increase in the sum of diameters of all target and all new measurable lesions.
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Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first)
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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。
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。
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16日
初级完成 (实际的)
2018年4月4日
研究完成 (实际的)
2020年7月28日
研究注册日期
首次提交
2015年5月28日
首先提交符合 QC 标准的
2015年5月28日
首次发布 (估计)
2015年6月1日
研究记录更新
最后更新发布 (实际的)
2021年6月4日
上次提交的符合 QC 标准的更新
2021年5月11日
最后验证
2021年5月1日
更多信息
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.