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Uno studio su atezolizumab più tiragolumab in combinazione con paclitaxel e cisplatino rispetto a paclitaxel e cisplatino come trattamento di prima linea nei partecipanti con carcinoma esofageo localmente avanzato non resecabile, ricorrente non resecabile o metastatico (SKYSCRAPER-08)

4 agosto 2026 aggiornato da: Hoffmann-La Roche

Uno studio di fase III, randomizzato, in doppio cieco, controllato con placebo su atezolizumab più tiragolumab in combinazione con paclitaxel e cisplatino rispetto a paclitaxel e cisplatino come trattamento di prima linea in pazienti con carcinoma esofageo a cellule squamose non resecabile localmente avanzato, non resecabile ricorrente o metastatico

Lo scopo di questo studio è valutare l'efficacia e la sicurezza di atezolizumab più tiragolumab in combinazione con paclitaxel e cisplatino (PC) rispetto ad atezolizumab corrispondente a placebo più tiragolumab corrispondente a placebo più PC come trattamento di prima linea nei partecipanti con malattia localmente avanzata non resecabile, recidiva non resecabile , o carcinoma esofageo metastatico (CE). I partecipanti saranno randomizzati in un rapporto 1: 1 per ricevere uno dei seguenti regimi di trattamento durante la fase di induzione:

Braccio A: atezolizumab più tiragolumab e PC Braccio B: atezolizumab placebo più tiragolumab placebo e PC Dopo la fase di induzione, i partecipanti continueranno la terapia di mantenimento con atezolizumab più tiragolumab (braccio A) o atezolizumab corrispondente al placebo più tiragolumab corrispondente al placebo (braccio B).

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

461

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Descrizione

Criteri chiave di inclusione:

  • EC istologicamente confermata
  • Malattia localmente avanzata non resecabile, ricorrente non resecabile o metastatica
  • Malattia misurabile in base ai criteri di valutazione della risposta nei tumori solidi versione 1.1 (RECIST v1.1)
  • Performance Status dell'Eastern Cooperative Oncology Group (ECOG) pari a 0 o 1
  • Adeguata funzionalità ematologica e degli organi terminali
  • Le partecipanti di sesso femminile devono essere disposte a evitare la gravidanza e ad astenersi dal donare ovuli durante il periodo di trattamento e per 90 giorni dopo la dose finale
  • I partecipanti di sesso maschile con partner in età fertile devono impegnarsi a utilizzare due metodi contraccettivi e non devono donare sperma per la durata dello studio e 90 giorni dopo la dose finale

Criteri chiave di esclusione:

  • Trattamento con radiazioni palliative per EC entro 4 settimane prima dell'inizio del trattamento in studio
  • Evidenza di completa ostruzione esofagea non suscettibile di trattamento
  • Metastasi del sistema nervoso centrale (SNC) sintomatiche, non trattate o in progressione attiva
  • Dolore incontrollato correlato al tumore, versamento pleurico incontrollato, versamento pericardico o ascite che richiedono procedure di drenaggio ricorrenti
  • Attivo o storia di malattia autoimmune o immunodeficienza o malattia leptomeningea
  • Anamnesi di fibrosi polmonare idiopatica, polmonite organizzativa, polmonite indotta da farmaci o polmonite idiopatica o evidenza di polmonite attiva
  • Neoplasie diverse dalla CE entro 2 anni prima dello screening con un rischio trascurabile di metastasi o morte trattate adeguatamente con esito curativo atteso
  • Infezione grave nelle 4 settimane precedenti l'inizio del trattamento in studio o qualsiasi infezione attiva che, secondo l'opinione dello sperimentatore, potrebbe avere un impatto sulla sicurezza del paziente
  • Risultato positivo del test per il virus dell'immunodeficienza umana (HIV)
  • Epatite attiva B o epatite C
  • Precedente trattamento con agonisti CD137 o terapie di blocco del checkpoint immunitario, anticorpi terapeutici anti-CTLA-4, anti-TIGIT, anti-PD-1 e anti-PD-L1
  • Trattamento con qualsiasi terapia sperimentale prima dell'inizio del trattamento in studio
  • Scarso accesso venoso periferico
  • Precedente trapianto di cellule staminali allogeniche o di organi solidi
  • Partecipazione concomitante ad un'altra sperimentazione clinica terapeutica

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Atezolizumab + Tiragolumab + PC
I partecipanti riceveranno atezolizumab e tiragolumab il giorno 1 di ogni ciclo di 21 giorni durante lo studio seguiti da paclitaxel e cisplatino il giorno 1 di ogni ciclo di 21 giorni fino a progressione della malattia, perdita di beneficio clinico o tossicità inaccettabile, durante la fase di trattamento di induzione.
Droga: Atezolizumab
Atezolizumab a una dose fissa di 1200 milligrammi (mg) somministrato per infusione endovenosa (IV) ogni 3 settimane (Q3W) il giorno 1 di ciascun ciclo di 21 giorni.
Altri nomi:
  • Tecentriq
Droga: Tiragolumab
Tiragolumab a una dose fissa di 600 mg somministrato per infusione endovenosa ogni tre settimane il giorno 1 di ciascun ciclo di 21 giorni.
Altri nomi:
  • MTIG7192A
Droga: Paclitaxel
Paclitaxel 175 mg/m^2 somministrato per infusione endovenosa il giorno 1 di ciascun ciclo di 21 giorni per 6 cicli.
Droga: Cisplatino
Cisplatino 60-80 mg/m^2 somministrato per infusione endovenosa il giorno 1 di ciascun ciclo di 21 giorni per 6 cicli.
Comparatore placebo: Placebo + computer
I partecipanti riceveranno atezolizumab corrispondente al placebo e tiragolumab corrispondente al placebo il giorno 1 di ogni ciclo di 21 giorni durante lo studio seguito da paclitaxel e cisplatino il giorno 1 di ogni ciclo di 21 giorni fino alla progressione della malattia, perdita di beneficio clinico o tossicità inaccettabile, durante il fase di trattamento di induzione.
Droga: Paclitaxel
Paclitaxel 175 mg/m^2 somministrato per infusione endovenosa il giorno 1 di ciascun ciclo di 21 giorni per 6 cicli.
Droga: Cisplatino
Cisplatino 60-80 mg/m^2 somministrato per infusione endovenosa il giorno 1 di ciascun ciclo di 21 giorni per 6 cicli.
Droga: Atezolizumab corrispondente al placebo
Atezolizumab corrispondente al placebo somministrato per infusione endovenosa, Q3W il giorno 1 di ogni ciclo di 21 giorni.
Droga: Tiragolumab Matching Placebo
Tiragolumab corrispondente al placebo somministrato per infusione endovenosa, Q3W il giorno 1 di ogni ciclo di 21 giorni.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Independent Review Facility (IRF)-Assessed Progression-free Survival (PFS)
Lasso di tempo: 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)
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Investigator-assessed PFS
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Hoffmann-La Roche

Investigatori

  • Direttore dello studio: Clinical Trials, Hoffmann-La Roche

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

30 ottobre 2020

Completamento primario (Effettivo)

13 febbraio 2023

Completamento dello studio (Effettivo)

28 agosto 2025

Date di iscrizione allo studio

Primo inviato

3 settembre 2020

Primo inviato che soddisfa i criteri di controllo qualità

3 settembre 2020

Primo Inserito (Effettivo)

7 settembre 2020

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

27 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

4 agosto 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • YO42138

Piano per i dati dei singoli partecipanti (IPD)

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SÌ

Descrizione del piano IPD

I ricercatori qualificati possono richiedere l'accesso ai dati dei singoli pazienti attraverso la piattaforma di richiesta dei dati degli studi clinici (www.vivli.org). Ulteriori dettagli sui criteri di Roche per gli studi ammissibili sono disponibili qui (https://vivli.org/ourmember/roche/). Per ulteriori dettagli sulla politica globale di Roche sulla condivisione delle informazioni cliniche e su come richiedere l'accesso ai documenti relativi agli studi clinici, vedere qui (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

Sì

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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