- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02458638
A Study of Atezolizumab in Advanced Solid Tumors
11 de maio de 2021 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
474
Estágio
- Fase 2
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Hamburg, Alemanha, 20246
- Uniklinik-Eppendorf; Zentren F. Innere Medizin-Klinik U. Poliklinik
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Heidelberg, Alemanha, 69120
- Universitatsklinik Heidelberg; Universitätshautklinik und Nationales Centrum für Tumorerkrankungen
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Trier, Alemanha, 54290
- Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie
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RJ
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Rio de Janeiro, RJ, Brasil, 20231-050
- INCA 1- Instituto Nacional de Câncer X
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RS
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Porto Alegre, RS, Brasil, 90035-903
- Hospital das Clinicas - UFRGS
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SP
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Sao Paulo, SP, Brasil, 01246-000
- Instituto do Cancer do Estado de Sao Paulo - ICESP
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British Columbia
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Vancouver, British Columbia, Canadá, V5Z 4E6
- BCCA-Vancouver Cancer Centre
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Ontario
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Toronto, Ontario, Canadá, M5G 2M9
- University Health Network; Princess Margaret Hospital; Medical Oncology Dept
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Aarhus N, Dinamarca, 8200
- Aarhus Universitetshospital; Kræftafdelingen
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Herlev, Dinamarca, 2730
- Herlev Hospital; Afdeling for Kræftbehandling
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Odense C, Dinamarca, 5000
- Odense Universitetshospital, Onkologisk Afdeling, Klinisk Forsknings Enhed
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Barcelona, Espanha, 08035
- Hospital Univ Vall d'Hebron; Servicio de Oncologia
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Navarra
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Pamplona, Navarra, Espanha, 31008
- Clinica Universitaria de Navarra; Servicio de Oncologia
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New York
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New York, New York, Estados Unidos, 10027
- Columbia University Medical Center
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New York, New York, Estados Unidos, 10065
- Memorial Sloan Kettering
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Ohio
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Cleveland, Ohio, Estados Unidos, 44195
- The Cleveland Clinic Foundation
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Tennessee
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Nashville, Tennessee, Estados Unidos, 37203
- Sarah Cannon Cancer Center and Research Institute
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Texas
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Houston, Texas, Estados Unidos, 77030
- MD Anderson Cancer Center
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Moscow, Federação Russa, 115478
- Russian Oncology Research Center n.a. N.N. Blokhin Dpt of Clinical Pharmacology and Chemotherapy
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Saint-Petersburg, Federação Russa, 197758
- S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)
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Helsinki, Finlândia, 00029
- Helsinki University Central Hospital; Dept of Oncology
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Bordeaux, França, 33076
- Institut Bergonie
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Lyon, França, 69373
- Centre Leon Berard; Departement Oncologie Medicale
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Paris, França, 75475
- Hopital Saint Louis, Service D Oncologie Medicale
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Villejuif, França, 94805
- Institut Gustave Roussy
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Amsterdam, Holanda, 1066 CX
- Antoni van Leeuwenhoek Ziekenhuis
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Rotterdam, Holanda, 3015 GD
- Erasmus MC
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Utrecht, Holanda, 3584 CX
- Universitair Medisch Centrum Utrecht
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Dublin, Irlanda, 4
- St Vincent'S Uni Hospital; Medical Oncology
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Dublin, Irlanda
- St James' Hospital; Cancer Clinical Trials Office
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Campania
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Napoli, Campania, Itália, 80131
- Istituto Nazionale Tumori Fondazione G. Pascale
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Lombardia
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Milano, Lombardia, Itália, 20133
- Fondazione IRCCS Istituto Nazionale dei Tumori
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Toscana
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Siena, Toscana, Itália, 53100
- Azienda Ospedaliera Universitaria Senese, U.O.C. Immunoterapia Oncologica
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Bergen, Noruega, 5021
- Haukeland Universitetssjukehus; Klinisk forskningspost
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Oslo, Noruega, 0310
- Oslo Universitetssykehus HF; Radiumhospitalet
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Edirne, Peru, 22030
- Trakya University Medical Faculty
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Istanbul, Peru, 34300
- Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology
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Istanbul, Peru, 34384
- Prof. Dr. Cemil Tascioglu City Hospital; Med Onc
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Sihhiye/Ankara, Peru, 06230
- Hacettepe Uni Medical Faculty Hospital; Oncology Dept
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Bydgoszcz, Polônia, 85-796
- Centrum Onkologii w Bydgoszczy
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Gdańsk, Polônia, 80-214
- Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii
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Warszawa, Polônia, 02-781
- Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie; Klinika Now. Tkanek Miekkich,Kosci i Czer.
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Bebington, Reino Unido, CH63 4JY
- Clatterbridge Cancer Centre
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Southampton, Reino Unido, SO16 6YD
- Southampton General Hospital; Medical Oncology
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Fribourg, Suíça, 1708
- Freiburger Spital; Onkologie
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St. Gallen, Suíça, 9007
- Kantonsspital St. Gallen; Onkologie/Hämatologie
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Graz, Áustria, 8036
- LKH-UNIV. KLINIKUM GRAZ; Klinische Abteilung für Onkologie
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Wien, Áustria, 1090
- Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Chemotherapie & Infektionskrankhei
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: 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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Medicamento: Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (PD-L1) antibody
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.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Non-progression Rate (NPR) at 18 Weeks
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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NPR at 24 Weeks
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Baseline up to 4.5 years
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Baseline up to 4.5 years
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Serum Concentration of Atezolizumab
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
16 de julho de 2015
Conclusão Primária (Real)
4 de abril de 2018
Conclusão do estudo (Real)
28 de julho de 2020
Datas de inscrição no estudo
Enviado pela primeira vez
28 de maio de 2015
Enviado pela primeira vez que atendeu aos critérios de CQ
28 de maio de 2015
Primeira postagem (Estimativa)
1 de junho de 2015
Atualizações de registro de estudo
Última Atualização Postada (Real)
4 de junho de 2021
Última atualização enviada que atendeu aos critérios de controle de qualidade
11 de maio de 2021
Última verificação
1 de maio de 2021
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- MO29518
- 2015-000269-30 (Número EudraCT)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em Tumores
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Aadi Bioscience, Inc.RecrutamentoTumor Sólido Avançado | Tumor | Tumor SólidoEstados Unidos
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Sorrento Therapeutics, Inc.RetiradoTumor Sólido | Tumor Sólido Recidivante | Tumor Refratário
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Memorial Sloan Kettering Cancer CenterRecrutamentoTumor Sólido | Tumor Sólido, Adulto | Tumor Sólido, Não Especificado, AdultoEstados Unidos
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Memorial Sloan Kettering Cancer CenterLincoln Medical and Mental Health CenterRecrutamentoTumor Sólido | Tumor Sólido, Adulto | Tumor Sólido, Não Especificado, AdultoEstados Unidos, Porto Rico
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Memorial Sloan Kettering Cancer CenterLincoln Medical and Mental Health CenterRecrutamentoTumor Sólido | Tumor Sólido, Adulto | Tumor Sólido, Não Especificado, AdultoEstados Unidos, Porto Rico
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RemeGen Co., Ltd.ConcluídoTumor Sólido Metastático | Tumor Sólido Localmente Avançado | Tumor sólido irressecávelAustrália
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Yonsei UniversityMerck KGaA, Darmstadt, GermanyAtivo, não recrutandoTumor de Mutação Positiva PD-L1 | Tumor de Mutação Positiva EBV | Tumor Mutação MSI-H | Tumor de mutação POLE/POLD1Republica da Coréia
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Baodong QinRecrutamento
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National Health Research Institutes, TaiwanNational Cheng-Kung University HospitalRecrutamento
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Elpiscience Biopharma, Ltd.Shanghai Junshi Bioscience Co., Ltd.RecrutamentoNeoplasias | Tumor Sólido | Tumor malignoChina
Ensaios clínicos em Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (PD-L1) antibody
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Fred Hutchinson Cancer CenterNational Cancer Institute (NCI); Affini-T Therapeutics, Inc.Ativo, não recrutando
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SWOG Cancer Research NetworkNational Cancer Institute (NCI)SuspensoCâncer de Bexiga Estágio II AJCC v8 | Carcinoma da Bexiga Infiltrando o Músculo da Parede da Bexiga | Carcinoma urotelial infiltrante da pelve renal e ureterEstados Unidos