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Un estudio de atezolizumab más tiragolumab en combinación con paclitaxel y cisplatino en comparación con paclitaxel y cisplatino como tratamiento de primera línea en participantes con carcinoma de esófago irresecable localmente avanzado, irresecable recurrente o metastásico (SKYSCRAPER-08)

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

Un estudio de fase III, aleatorizado, doble ciego, controlado con placebo de atezolizumab más tiragolumab en combinación con paclitaxel y cisplatino en comparación con paclitaxel y cisplatino como tratamiento de primera línea en pacientes con carcinoma de células escamosas de esófago no resecable localmente avanzado, recurrente no resecable o metastásico

El propósito de este estudio es evaluar la eficacia y la seguridad de atezolizumab más tiragolumab en combinación con paclitaxel y cisplatino (PC) en comparación con atezolizumab equivalente a placebo más tiragolumab equivalente a placebo más PC como tratamiento de primera línea en participantes con cáncer recurrente irresecable localmente avanzado e irresecable. , o carcinoma esofágico metastásico (CE). Los participantes serán aleatorizados en una proporción de 1:1 para recibir uno de los siguientes regímenes de tratamiento durante la fase de inducción:

Grupo A: atezolizumab más tiragolumab y PC Grupo B: atezolizumab placebo más tiragolumab placebo y PC Después de la fase de inducción, los participantes continuarán la terapia de mantenimiento con atezolizumab más tiragolumab (Brazo A) o atezolizumab con placebo más tiragolumab con placebo (Brazo B).

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

461

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Descripción

Criterios clave de inclusión:

  • CE confirmado histológicamente
  • Enfermedad localmente avanzada irresecable, recurrente irresecable o metastásica
  • Enfermedad medible según los Criterios de Evaluación de Respuesta en Tumores Sólidos versión 1.1 (RECIST v1.1)
  • Estado funcional del Grupo Oncológico Cooperativo del Este (ECOG) de 0 o 1
  • Función hematológica y de órganos diana adecuada
  • Las participantes femeninas deben estar dispuestas a evitar el embarazo y abstenerse de donar óvulos durante el período de tratamiento y durante los 90 días posteriores a la dosis final.
  • Los participantes masculinos con parejas en edad fértil deben comprometerse a usar dos métodos anticonceptivos y no deben donar esperma durante la duración del estudio y 90 días después de la dosis final.

Criterios clave de exclusión:

  • Tratamiento de radiación paliativa para EC dentro de las 4 semanas anteriores al inicio del tratamiento del estudio.
  • Evidencia de obstrucción esofágica completa no susceptible de tratamiento
  • Metástasis del sistema nervioso central (SNC) sintomáticas, no tratadas o en progresión activa
  • Dolor relacionado con el tumor no controlado, derrame pleural no controlado, derrame pericárdico o ascitis que requiere procedimientos de drenaje recurrentes
  • Activo o antecedentes de enfermedad autoinmune o inmunodeficiencia o enfermedad leptomeníngea
  • Antecedentes de fibrosis pulmonar idiopática, neumonía organizada, neumonitis inducida por fármacos o neumonitis idiopática, o evidencia de neumonitis activa
  • Neoplasias malignas distintas de EC dentro de los 2 años anteriores a la selección con un riesgo insignificante de metástasis o muerte tratados adecuadamente con resultado curativo esperado
  • Infección grave dentro de las 4 semanas previas al inicio del tratamiento del estudio o cualquier infección activa que, en opinión del investigador, podría afectar la seguridad del paciente.
  • Resultado positivo de la prueba para el virus de la inmunodeficiencia humana (VIH)
  • Hepatitis B activa o hepatitis C
  • Tratamiento previo con agonistas de CD137 o terapias de bloqueo del punto de control inmunitario, anticuerpos terapéuticos anti-CTLA-4, anti-TIGIT, anti-PD-1 y anti-PD-L1
  • Tratamiento con cualquier terapia en investigación antes del inicio del tratamiento del estudio
  • Mal acceso venoso periférico
  • Trasplante alogénico previo de células madre u órganos sólidos
  • Participación concurrente en otro ensayo clínico terapéutico

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Atezolizumab + Tiragolumab + CP
Los participantes recibirán atezolizumab y tiragolumab el Día 1 de cada ciclo de 21 días durante el estudio, seguidos de paclitaxel y cisplatino el Día 1 de cada ciclo de 21 días hasta la progresión de la enfermedad, pérdida del beneficio clínico o toxicidad inaceptable, durante la fase de tratamiento de inducción.
Droga: Atezolizumab
Atezolizumab en una dosis fija de 1200 miligramos (mg) administrados por infusión intravenosa (IV) cada 3 semanas (Q3W) el Día 1 de cada ciclo de 21 días.
Otros nombres:
  • Tecentriq
Droga: Tiragolumab
Tiragolumab a una dosis fija de 600 mg administrados por infusión IV cada Q3W en el Día 1 de cada ciclo de 21 días.
Otros nombres:
  • MTIG7192A
Droga: Paclitaxel
Paclitaxel 175 mg/m^2 administrado por infusión IV el día 1 de cada ciclo de 21 días durante 6 ciclos.
Droga: Cisplatino
Cisplatino 60-80 mg/m^2 administrado por infusión IV el día 1 de cada ciclo de 21 días durante 6 ciclos.
Comparador de placebos: Placebo + CP
Los participantes recibirán atezolizumab equivalente al placebo y tiragolumab equivalente al placebo el día 1 de cada ciclo de 21 días durante el estudio, seguido de paclitaxel y cisplatino el día 1 de cada ciclo de 21 días hasta la progresión de la enfermedad, pérdida del beneficio clínico o toxicidad inaceptable, durante el fase de tratamiento de inducción.
Droga: Paclitaxel
Paclitaxel 175 mg/m^2 administrado por infusión IV el día 1 de cada ciclo de 21 días durante 6 ciclos.
Droga: Cisplatino
Cisplatino 60-80 mg/m^2 administrado por infusión IV el día 1 de cada ciclo de 21 días durante 6 ciclos.
Droga: Placebo compatible con atezolizumab
Atezolizumab equivalente al placebo administrado por infusión IV, Q3W en el Día 1 de cada ciclo de 21 días.
Droga: Placebo equivalente de Tiragolumab
Tiragolumab equivalente al placebo administrado por infusión IV, Q3W en el Día 1 de cada ciclo de 21 días.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Independent Review Facility (IRF)-Assessed Progression-free Survival (PFS)
Periodo de tiempo: 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)
Periodo de tiempo: 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 resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Investigator-assessed PFS
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Hoffmann-La Roche

Investigadores

  • Director de estudio: Clinical Trials, Hoffmann-La Roche

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

30 de octubre de 2020

Finalización primaria (Actual)

13 de febrero de 2023

Finalización del estudio (Actual)

28 de agosto de 2025

Fechas de registro del estudio

Enviado por primera vez

3 de septiembre de 2020

Primero enviado que cumplió con los criterios de control de calidad

3 de septiembre de 2020

Publicado por primera vez (Actual)

7 de septiembre de 2020

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

27 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

4 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • YO42138

Plan de datos de participantes individuales (IPD)

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SÍ

Descripción del plan IPD

Los investigadores calificados pueden solicitar acceso a datos de pacientes individuales a través de la plataforma de solicitud de datos de estudios clínicos (www.vivli.org). Más detalles sobre los criterios de Roche para estudios elegibles están disponibles aquí (https://vivli.org/ourmember/roche/). Para obtener más detalles sobre la Política global de Roche sobre el intercambio de información clínica y cómo solicitar acceso a documentos de estudios clínicos relacionados, consulte aquí (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

Sí

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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