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Um estudo de atezolizumabe mais tiragolumabe em combinação com paclitaxel e cisplatina em comparação com paclitaxel e cisplatina como tratamento de primeira linha em participantes com carcinoma esofágico localmente avançado irressecável, recorrente irressecável ou metastático (SKYSCRAPER-08)

4 de agosto de 2026 atualizado por: Hoffmann-La Roche

Um estudo de fase III, randomizado, duplo-cego, controlado por placebo de atezolizumabe mais tiragolumabe em combinação com paclitaxel e cisplatina comparado com paclitaxel e cisplatina como tratamento de primeira linha em pacientes com carcinoma de células escamosas de esôfago irressecável localmente avançado, irressecável recorrente ou metastático

O objetivo deste estudo é avaliar a eficácia e segurança de atezolizumabe mais tiragolumabe em combinação com paclitaxel e cisplatina (PC) em comparação com atezolizumabe correspondente placebo mais tiragolumabe correspondente placebo mais PC como tratamento de primeira linha em participantes com localmente avançado irressecável, recorrente irressecável , ou carcinoma esofágico metastático (EC). Os participantes serão randomizados em uma proporção de 1:1 para receber um dos seguintes regimes de tratamento durante a fase de indução:

Braço A: Atezolizumabe mais Tiragolumabe e PC Braço B: Atezolizumabe placebo mais Tiragolumabe placebo e PC Após a fase de indução, os participantes continuarão a terapia de manutenção com atezolizumabe mais tiragolumabe (Grupo A) ou atezolizumabe com placebo mais tiragolumabe com placebo (Grupo B).

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

461

Estágio

  • Fase 3

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

  • China
      • Anhui, China, 230001
        • Anhui Provincial Hospital
      • Anyang, China, 455000
        • Anyang Tumor Hosptial
      • Beijing, China
        • Beijing Luhe Hospital Capital Medical University
      • Changchun, China, 130021
        • The First Hospital of Jilin University
      • Changchun, China, 132013
        • Jilin cancer hospital
      • Changsha, China, 410013
        • Hunan Cancer Hospital
      • Chengde, China, 067020
        • Affiliated Hospital of Chengde Medical University
      • Chengdu, China, 610041
        • West China Hospital, Sichuan University
      • Chengdu, China, 610041
        • Sichuan Provincial Cancer Hospital
      • Chongqing, China, 404000
        • Chongqing Sanxia Central Hospital
      • Foshan, China, 510000
        • The First People's Hospital of Foshan
      • Fuzhou, China, 350014
        • Fujian Cancer Hospital
      • Fuzhou, China
        • Fujian Provincial Hospital
      • Guangdong Province Guangzhou City, China, 510515
        • Southern medical university Nanfang hospital
      • Hangzhou, China, 310022
        • Zhejiang Cancer Hospital
      • Harbin, China, 150081
        • Harbin Medical University Cancer Hospital
      • Hefei, China, 230601
        • The Second Affiliated Hospital of Anhui Medical University
      • Hefei, China, 12345
        • Anhui Province Cancer Hospital
      • Huai'an, China
        • Huai'an first people's hospital
      • Huai'an, China
        • The Second People's Hospital of Huai'an
      • Jining, China
        • Affiliated Hopsital of Jining Medical University
      • Lanzhou, China, 730000
        • Gansu Province People Hospital
      • Lianyungang, China, 222002
        • The First People's Hospital of Lian Yun Gang
      • Linyi, China, 276034
        • Linyishi Cancer Hospital
      • Luoyang, China, 471003
        • The First Affiliated Hospital to Henan University of Science and Technology
      • Nanjing, China, 211100
        • Jiangsu Cancer Hospital
      • Nanjing, China, 210029
        • Jiangsu Province Hospital of Chinese Medicine
      • Nantong, China, 226361
        • Nan Tong Tumor Hospital
      • Shanghai, China, 200000
        • Shanghai Chest Hospital
      • Shanghai, China, 200032
        • Zhongshan Hospital Fudan University
      • Shanghai, China, 200120
        • Fudan University Shanghai Cancer Center
      • Shantou, China, 515041
        • Cancer Hospital of Shantou University Medical College
      • Shengyang, China, 110042
        • Liaoning Provincial Cancer Hospital
      • Suining, China, 629000
        • Suining Central Hospital
      • Tianjin, China, 300060
        • Tianjin Cancer Hospital
      • Weifang, China
        • Weifang People's Hospital
      • Wuhan, China, 430079
        • Hubei Cancer Hospital
      • Wuhan, China, 430022
        • Wuhan Union Hospital Tongji Medical College, Huazhong University of Science and Technology
      • Wuxi, China, 214122
        • Affiliated Hospital of Jiangnan University(Wuxi Fourth People's Hospital )
      • Xi'an, China, 710061
        • First Affiliated Hospital of Medical College of Xi'an Jiaotong University
      • Xi'an, China, 710038
        • The Second Affiliated Hospital of The Fourth Military Medical University (Tangdu Hospital)
      • Xiamen, China, 361003
        • The First Affiliated Hospital of Xiamen University
      • Xiamen, China, 361004
        • Zhongshan Hospital Xiamen University
      • Xiangyang, China
        • Xiangyang Central Hospital
      • Xinxiang, China
        • The First Affiliated Hospital of Xinxiang Medical University
      • Xuzhou, China
        • Xuzhou Central Hospital
      • Yangzhou, China, 225001
        • Northern Jangsu People's Hospital
      • Zhengzhou, China, 450008
        • Henan Cancer Hospital
      • Zhengzhou, China, 450052
        • The First Affiliated Hospital of Zhengzhou University
  • Coréia do Sul
      • Daegu, Coréia do Sul, 41404
        • Kyungpook National University Chilgok Hospital
      • Goyang-si, Coréia do Sul, 10408
        • National Cancer Center
      • Seongnam-si, Coréia do Sul, 13605
        • Seoul National University Bundang Hospital
      • Seoul, Coréia do Sul, 05505
        • Asan Medical Center
      • Seoul, Coréia do Sul, 06351
        • Samsung Medical Center
      • Seoul, Coréia do Sul, 03722
        • Severance Hospital, Yonsei University Health System
      • Seoul, Coréia do Sul, 08308
        • Korea University Guro Hospital
  • Hong Kong
      • Hong Kong, Hong Kong
        • Queen Mary Hospital
      • Shatin, Hong Kong
        • Prince of Wales Hosp
  • Tailândia
      • Bangkok, Tailândia, 10700
        • Siriraj Hospital
      • Bangkok, Tailândia, 10400
        • Rajavithi Hospital
      • Bangkok, Tailândia, 10330
        • Chulalongkorn Hospital
      • Bangkok, Tailândia, 10400
        • Ramathibodi Hospital
      • Songkhla, Tailândia, 90110
        • Songklanagarind Hospital
  • Taiwan
      • Kaohisung, Taiwan
        • Chang Gung Medical Foundation - Kaohsiung
      • Tainan, Taiwan, 00704
        • National Cheng Kung University Hospital
      • Taipei, Taiwan, 112201
        • Taipei Veterans General Hospital
      • Zhongzheng Dist., Taiwan, 10048
        • National Taiwan University Hospital

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

Descrição

Principais Critérios de Inclusão:

  • EC confirmado histologicamente
  • Doença localmente avançada irressecável, recorrente irressecável ou metastática
  • Doença mensurável por critérios de avaliação de resposta em tumores sólidos versão 1.1 (RECIST v1.1)
  • Status de Desempenho do Eastern Cooperative Oncology Group (ECOG) de 0 ou 1
  • Função hematológica e de órgão-alvo adequada
  • As participantes do sexo feminino devem estar dispostas a evitar a gravidez e abster-se de doar óvulos durante o período de tratamento e por 90 dias após a dose final
  • Participantes do sexo masculino com parceiras em idade fértil devem se comprometer com o uso de dois métodos contraceptivos e não devem doar esperma durante a duração do estudo e 90 dias após a dose final

Principais Critérios de Exclusão:

  • Tratamento de radiação paliativo para CE dentro de 4 semanas antes do início do tratamento do estudo
  • Evidência de obstrução esofágica completa não passível de tratamento
  • Metástases do sistema nervoso central (SNC) sintomáticas, não tratadas ou com progressão ativa
  • Dor descontrolada relacionada ao tumor, derrame pleural descontrolado, derrame pericárdico ou ascite exigindo procedimentos de drenagem recorrentes
  • Ativo ou histórico de doença autoimune ou deficiência imunológica ou doença leptomeníngea
  • História de fibrose pulmonar idiopática, pneumonia em organização, pneumonite induzida por drogas ou pneumonite idiopática ou evidência de pneumonite ativa
  • Malignidades diferentes de CE dentro de 2 anos antes da triagem com risco insignificante de metástase ou morte adequadamente tratadas com resultado curativo esperado
  • Infecção grave dentro de 4 semanas antes do início do tratamento do estudo ou qualquer infecção ativa que, na opinião do investigador, possa afetar a segurança do paciente
  • Resultado do teste positivo para o vírus da imunodeficiência humana (HIV)
  • Hepatite B ativa ou hepatite C
  • Tratamento prévio com agonistas de CD137 ou terapias de bloqueio de checkpoint imunológico, anticorpos terapêuticos anti-CTLA-4, anti-TIGIT, anti-PD-1 e anti-PD-L1
  • Tratamento com qualquer terapia experimental antes do início do tratamento do estudo
  • Acesso venoso periférico deficiente
  • Transplante alogênico prévio de células-tronco ou órgãos sólidos
  • Participação concomitante em outro ensaio clínico terapêutico

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: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Atezolizumabe + Tiragolumabe + PC
Os participantes receberão atezolizumabe e tiragolumabe no dia 1 de cada ciclo de 21 dias durante o estudo, seguido de paclitaxel e cisplatina no dia 1 de cada ciclo de 21 dias até a progressão da doença, perda de benefício clínico ou toxicidade inaceitável, durante a fase de tratamento de indução.
Medicamento: Atezolizumabe
Atezolizumabe em uma dose fixa de 1200 miligramas (mg) administrado por infusão intravenosa (IV) a cada 3 semanas (Q3W) no Dia 1 de cada ciclo de 21 dias.
Outros nomes:
  • Tecentriq
Medicamento: Tiragolumabe
Tiragolumabe em uma dose fixa de 600 mg administrado por infusão IV a cada Q3W no dia 1 de cada ciclo de 21 dias.
Outros nomes:
  • MTIG7192A
Medicamento: Paclitaxel
Paclitaxel 175 mg/m^2 administrado por infusão IV no dia 1 de cada ciclo de 21 dias por 6 ciclos.
Medicamento: Cisplatina
Cisplatina 60-80 mg/m^2 administrado por infusão IV no dia 1 de cada ciclo de 21 dias por 6 ciclos.
Comparador de Placebo: Placebo + PC
Os participantes receberão placebo correspondente de atezolizumabe e placebo correspondente de tiragolumabe no dia 1 de cada ciclo de 21 dias durante o estudo, seguido de paclitaxel e cisplatina no dia 1 de cada ciclo de 21 dias até a progressão da doença, perda de benefício clínico ou toxicidade inaceitável, durante o fase de tratamento de indução.
Medicamento: Paclitaxel
Paclitaxel 175 mg/m^2 administrado por infusão IV no dia 1 de cada ciclo de 21 dias por 6 ciclos.
Medicamento: Cisplatina
Cisplatina 60-80 mg/m^2 administrado por infusão IV no dia 1 de cada ciclo de 21 dias por 6 ciclos.
Medicamento: Placebo correspondente atezolizumabe
Placebo correspondente atezolizumabe administrado por infusão IV, Q3W no dia 1 de cada ciclo de 21 dias.
Medicamento: Placebo Correspondente Tiragolumabe
Tiragolumabe correspondente placebo administrado por infusão IV, Q3W no dia 1 de cada ciclo de 21 dias.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Independent Review Facility (IRF)-Assessed Progression-free Survival (PFS)
Prazo: From randomization to the first occurrence of PD or death from any cause, whichever occurred first (up to approximately 19 months)
PFS was defined as the time from randomization to the first occurrence of progressive disease (PD) or death from any cause (whichever occurred first), as determined by an IRF according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1). PD was defined as at least a 20% increase in the sum of diameters (SOD) of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 millimeters (mm) or unequivocal progression of existing non-target lesions. Kaplan-Meier (KM) method was used to estimate median PFS.
From randomization to the first occurrence of PD or death from any cause, whichever occurred first (up to approximately 19 months)
Overall Survival (OS)
Prazo: From randomization to death from any cause (up to approximately 27.5 months)
OS was defined as the time from randomization to death from any cause. K-M method was used to estimate median OS.
From randomization to death from any cause (up to approximately 27.5 months)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Investigator-assessed PFS
Prazo: From randomization to the first occurrence of PD or death from any cause, whichever occurs first (up to approximately 19 months)
PFS was defined as the time from randomization to the first occurrence of PD or death from any cause (whichever occurred first), as determined by the investigator according to RECIST v1.1. PD was defined at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. K-M method was used to estimate median PFS.
From randomization to the first occurrence of PD or death from any cause, whichever occurs first (up to approximately 19 months)
IRF-assessed Confirmed Objective Response Rate (ORR)
Prazo: Up to approximately 19 months
IRF-assessed confirmed ORR was defined as the percentage of participants with an objective response (OR), characterized by a complete response (CR) or partial response (PR) on 2 consecutive occasions ≥ 4 weeks apart, as determined by an IRF according to RECIST v1.1. CR was defined as disappearance of all target lesions. & normalization of tumor marker level. Additionally, any pathological lymph nodes (whether target or non-target) must have a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR.
Up to approximately 19 months
Investigator-assessed Confirmed ORR
Prazo: Up to approximately 19 months
Investigator-assessed confirmed ORR was defined as the percentage of participants with an OR, characterized by a CR or a PR on 2 consecutive occasions ≥ 4 weeks apart, as determined by the investigator according to RECIST v1.1. CR was defined as disappearance of all target lesions. & normalization of tumor marker level. Additionally, any pathological lymph nodes (whether target or non-target) must have a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR.
Up to approximately 19 months
IRF-assessed Duration of Objective Response (DOR)
Prazo: From the first occurrence of a of a confirmed OR to PD or death from any cause, whichever occurred first (up to approximately 19 months)
DOR was defined as the time from the first occurrence of a confirmed OR to PD or death from any cause (whichever occurred first), as determined by an IRF according to RECIST v1.1. OR was defined as either a CR or a PR on 2 consecutive occasions ≥ 4 weeks apart. CR was defined as disappearance of all target lesions. & normalization of tumor marker level. Additionally, any pathological lymph nodes (whether target or non-target) must have a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD on study (including baseline). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. K-M method was used to estimate median DOR.
From the first occurrence of a of a confirmed OR to PD or death from any cause, whichever occurred first (up to approximately 19 months)
Investigator-assessed DOR
Prazo: From the first occurrence of a of a confirmed OR to PD or death from any cause, whichever occurred first (up to approximately 19 months)
DOR was defined as the time from the first occurrence of a confirmed OR to PD or death from any cause (whichever occurred first), as determined by an IRF according to RECIST v1.1. OR was defined as either a CR or a PR on 2 consecutive occasions ≥ 4 weeks apart. CR was defined as disappearance of all target lesions. & normalization of tumor marker level. Additionally, any pathological lymph nodes (whether target or non-target) must have a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD on study (including baseline). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. K-M method was used to estimate median DOR.
From the first occurrence of a of a confirmed OR to PD or death from any cause, whichever occurred first (up to approximately 19 months)
Time to Confirmed Deterioration (TTCD) in Participant-reported Physical Functioning, as Measured by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30)
Prazo: Up to approximately 27 months
Clinically meaningful changes in physical functioning as measured by the EORTC QLQ-C30. EORTC QLQ-C30 is a self-reported measure, consisting of 30 questions that assess 5 aspects of participants functioning (physical, emotional, role, cognitive and social), 3 symptom scales (fatigue, nausea and vomiting, and pain), global health status/quality of life (GHS/QoL), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties) within the previous week. Physical functioning was scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much. Scores were linearly transformed to a range of 0 to 100, with higher scores (i.e. closer to 100) reflecting better functioning. Participants were considered "Worsened" if their baseline score decreased by ≥10 points. K-M method was used to estimate median TTCD.
Up to approximately 27 months
TTCD in Participant-reported Role Functioning (RF), as Measured by EORTC QLQ-C30
Prazo: Up to approximately 27 months
Clinically meaningful changes in role functioning as measured by the EORTC QLQ-C30. EORTC QLQ-C30 is a self-reported measure, consisting of 30 questions that assess 5 aspects of participants functioning (physical, emotional, role, cognitive and social), 3 symptom scales (fatigue, nausea and vomiting, and pain), GHS/QoL, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties) within the previous week. Role functioning was scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much. Scores were linearly transformed to a range of 0 to 100, with higher scores (i.e. closer to 100) reflecting better functioning. Participants were considered "Worsened" if their baseline score decreased by ≥10 points. K-M method was used to estimate median TTCD.
Up to approximately 27 months
TTCD in Participant-Reported GHS/QoL, as Measured by EORTC QLQ-C30
Prazo: Up to approximately 27 months
Clinically meaningful changes in GHS/QoL as measured by the EORTC QLQ-C30. EORTC QLQ-C30 is a self-reported measure, consisting of 30 questions that assess 5 aspects of participants functioning (physical, emotional, role, cognitive and social), 3 symptom scales (fatigue, nausea and vomiting, and pain), GHS/QoL, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties) within the previous week. GHS and QoL items were scored on a 7-point scale, with scores ranging from 1=Very poor to 7=Excellent. Scores were linearly transformed to a range of 0 to 100, with higher scores (i.e. closer to 100) reflecting better GHS/QoL. Participants were considered "Worsened" if their baseline score decreased by ≥10 points. K-M method was used to estimate median TTCD.
Up to approximately 27 months
TTCD in Participant-reported Dysphagia, as Measured by European Organisation for Research and Treatment of Cancer Quality-of-life Esophageal Cancer, Module 18 Questionnaire (EORTC QLQ-OES18)
Prazo: Up to approximately 27 months
Clinically meaningful changes in dysphagia as measured by the EORTC QLQ-OES18. EORTC QLQ-OES18 is a modular supplement to the EORTC QLQ-C30 questionnaire for use in participants with esophageal cancer. EORTC QLQ-OES18 consists of 4 multiple-item scale (dysphagia, eating, reflux, and pain) and 6 single items (trouble swallowing saliva, choked when swallowing, dry mouth, trouble with taste, trouble with coughing, and trouble talking) with a recall period of the previous week. Each symptom item was scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much. Scores were linearly transformed to a range of 0 to 100, with higher transformed scores (i.e. closer to 100) reflecting worse symptoms. Participants were considered "Worsened" if their baseline score increased by ≥ 10 points. K-M method was used to estimate median TTCD.
Up to approximately 27 months
Number of Participants With Adverse Events (AEs)
Prazo: Up to approximately 49.6 months
An AE was any untoward medical occurrence in a participant administered a pharmaceutical product, and which does not necessarily have a causal relationship with the treatment. An AE was therefore 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.
Up to approximately 49.6 months
Number of Participants With Cytokine-release Syndrome (CRS), With Severity Determined by the American Society for Transplantation and Cell Therapy (ASTCT) Consensus Grading Scale
Prazo: Up to approximately 49.6 months
CRS was defined as supraphysiologic response following administration of any immune therapy that results in activation/engagement of endogenous or infused T cells and/or other immune effector cells. Symptoms may be progressive, including fever at onset, and may also include hypotension, capillary leak (hypoxia), and end-organ dysfunction. Severity of CRS was determined per ASTCT Consensus Grading Criteria, which categorizes CRS into 5 grades: Grade 1: fever (≥38◦Celsius), with/without constitutional symptoms, in absence of hypotension & hypoxia; Grade 2: fever with hypotension not requiring vasopressors and/or hypoxia requiring low-flow oxygen; Grade 3: fever with hypotension requiring one vasopressor, with/without vasopressin, and/or hypoxia requiring high-flow oxygen; Grade 4: fever accompanied by hypotension requiring multiple vasopressors (excluding vasopressin) and/or hypoxia requiring positive-pressure ventilation; Grade 5: death due to CRS.
Up to approximately 49.6 months
Minimum Serum Concentration (Cmin) of Tiragolumab
Prazo: Pre-dose on Day 1 of Cycles 2, 3, 4, 8, 12, and 16 (1 Cycle=21 days)
Pre-dose on Day 1 of Cycles 2, 3, 4, 8, 12, and 16 (1 Cycle=21 days)
Maximum Serum Concentration (Cmax) of Tiragolumab
Prazo: 30 minutes post-dose on Day 1 of Cycle 1 (1 Cycle=21 days)
30 minutes post-dose on Day 1 of Cycle 1 (1 Cycle=21 days)
Cmin of Atezolizumab
Prazo: Pre-dose on Day 1 of Cycles 2, 3, 4, 8, 12, and 16 (1 Cycle=21 days)
Pre-dose on Day 1 of Cycles 2, 3, 4, 8, 12, and 16 (1 Cycle=21 days)
Cmax of Atezolizumab
Prazo: 30 minutes post-dose on Day 1 of Cycle 1 (1 Cycle=21 days)
30 minutes post-dose on Day 1 of Cycle 1 (1 Cycle=21 days)
Number of Participants With Anti-drug Antibodies (ADAs) to Tiragolumab
Prazo: Up to approximately 27.5 months
Participants were considered to be ADA positive if they were ADA negative at baseline but developed an ADA response following tiragolumab administration (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post-baseline samples was greater than the titer of the baseline sample by a scientifically reasonable margin such as at least 0.60 titer unit (t.u.) greater than the baseline titer result (treatment-enhanced ADA response). Participants with a positive post-baseline sample have been reported here.
Up to approximately 27.5 months
Number of Participants With ADAs to Atezolizumab
Prazo: Up to approximately 27.5 months
Participants were considered to be ADA positive if they were ADA negative at baseline but developed an ADA response following atezolizumab administration (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post-baseline samples was greater than the titer of the baseline sample by a scientifically reasonable margin such as at least 0.60 t.u. greater than the baseline titer result (treatment-enhanced ADA response). Participants with a positive post-baseline sample have been reported here.
Up to approximately 27.5 months

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Hoffmann-La Roche

Investigadores

  • Diretor de estudo: Clinical Trials, Hoffmann-La Roche

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.

Publicações Gerais

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)

30 de outubro de 2020

Conclusão Primária (Real)

13 de fevereiro de 2023

Conclusão do estudo (Real)

28 de agosto de 2025

Datas de inscrição no estudo

Enviado pela primeira vez

3 de setembro de 2020

Enviado pela primeira vez que atendeu aos critérios de CQ

3 de setembro de 2020

Primeira postagem (Real)

7 de setembro de 2020

Atualizações de registro de estudo

Última Atualização Postada (Real)

27 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

4 de agosto de 2026

Última verificação

1 de agosto de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • YO42138

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

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Descrição do plano IPD

Pesquisadores qualificados podem solicitar acesso a dados individuais de pacientes por meio da plataforma de solicitação de dados de estudos clínicos (www.vivli.org). Mais detalhes sobre os critérios da Roche para estudos elegíveis estão disponíveis aqui (https://vivli.org/ourmember/roche/). Para obter mais detalhes sobre a Política Global da Roche sobre o Compartilhamento de Informações Clínicas e como solicitar acesso a documentos de estudos clínicos relacionados, consulte aqui (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

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Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

produto fabricado e exportado dos EUA

Sim

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