Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Een studie van atezolizumab plus tiragolumab in combinatie met paclitaxel en cisplatine in vergelijking met paclitaxel en cisplatine als eerstelijnsbehandeling bij deelnemers met inoperabel lokaal gevorderd, inoperabel recidiverend of gemetastaseerd slokdarmcarcinoom (SKYSCRAPER-08)

4 augustus 2026 bijgewerkt door: Hoffmann-La Roche

Een gerandomiseerde, dubbelblinde, placebogecontroleerde fase III-studie van atezolizumab plus tiragolumab in combinatie met paclitaxel en cisplatine in vergelijking met paclitaxel en cisplatine als eerstelijnsbehandeling bij patiënten met inoperabel lokaal gevorderd, inoperabel recidiverend of gemetastaseerd plaveiselcelcarcinoom van de slokdarm

Het doel van deze studie is het evalueren van de werkzaamheid en veiligheid van atezolizumab plus tiragolumab in combinatie met paclitaxel en cisplatine (PC) in vergelijking met atezolizumab overeenkomende placebo plus tiragolumab overeenkomende placebo plus PC als eerstelijnsbehandeling bij deelnemers met inoperabel lokaal gevorderd, inoperabel recidief of gemetastaseerd slokdarmcarcinoom (EC). Deelnemers worden gerandomiseerd in een verhouding van 1:1 om tijdens de inductiefase een van de volgende behandelingsregimes te krijgen:

Arm A: Atezolizumab plus Tiragolumab en PC Arm B: Atezolizumab placebo plus Tiragolumab placebo en PC Na de inductiefase gaan de deelnemers door met de onderhoudstherapie met ofwel atezolizumab plus tiragolumab (arm A) of atezolizumab die overeenkomt met placebo plus tiragolumab die overeenkomt met placebo (arm B).

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

461

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • 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
  • Hongkong
      • Hong Kong, Hongkong
        • Queen Mary Hospital
      • Shatin, Hongkong
        • Prince of Wales Hosp
  • 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
  • Thailand
      • Bangkok, Thailand, 10700
        • Siriraj Hospital
      • Bangkok, Thailand, 10400
        • Rajavithi Hospital
      • Bangkok, Thailand, 10330
        • Chulalongkorn Hospital
      • Bangkok, Thailand, 10400
        • Ramathibodi Hospital
      • Songkhla, Thailand, 90110
        • Songklanagarind Hospital
  • Zuid -Korea
      • Daegu, Zuid -Korea, 41404
        • Kyungpook National University Chilgok Hospital
      • Goyang-si, Zuid -Korea, 10408
        • National Cancer Center
      • Seongnam-si, Zuid -Korea, 13605
        • Seoul National University Bundang Hospital
      • Seoul, Zuid -Korea, 05505
        • Asan Medical Center
      • Seoul, Zuid -Korea, 06351
        • Samsung Medical Center
      • Seoul, Zuid -Korea, 03722
        • Severance Hospital, Yonsei University Health System
      • Seoul, Zuid -Korea, 08308
        • Korea University Guro Hospital

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Belangrijkste opnamecriteria:

  • Histologisch bevestigd EC
  • Inoperabele lokaal gevorderde, inoperabele recidiverende of gemetastaseerde ziekte
  • Meetbare ziekte volgens responsevaluatiecriteria in solide tumoren versie 1.1 (RECIST v1.1)
  • Eastern Cooperative Oncology Group (ECOG) Prestatiestatus van 0 of 1
  • Adequate hematologische en eindorgaanfunctie
  • Vrouwelijke deelnemers moeten bereid zijn zwangerschap te vermijden en geen eicellen te doneren tijdens de behandelingsperiode en gedurende 90 dagen na de laatste dosis
  • Mannelijke deelnemers met partners in de vruchtbare leeftijd moeten zich verplichten tot het gebruik van twee anticonceptiemethoden en mogen geen sperma doneren gedurende de duur van het onderzoek en 90 dagen na de laatste dosis

Belangrijkste uitsluitingscriteria:

  • Palliatieve bestralingsbehandeling voor EC binnen 4 weken voorafgaand aan de start van de studiebehandeling
  • Bewijs van volledige slokdarmobstructie niet vatbaar voor behandeling
  • Symptomatische, onbehandelde of actief voortschrijdende metastasen van het centrale zenuwstelsel (CZS).
  • Ongecontroleerde tumorgerelateerde pijn, ongecontroleerde pleurale effusie, pericardiale effusie of ascites die terugkerende drainageprocedures vereisen
  • Actieve of voorgeschiedenis van auto-immuunziekte of immuundeficiëntie of leptomeningeale ziekte
  • Geschiedenis van idiopathische longfibrose, organiserende pneumonie, door geneesmiddelen veroorzaakte pneumonitis of idiopathische pneumonitis, of bewijs van actieve pneumonitis
  • Maligniteiten anders dan EC binnen 2 jaar voorafgaand aan screening met een verwaarloosbaar risico op metastase of overlijden adequaat behandeld met verwachte curatieve uitkomst
  • Ernstige infectie binnen 4 weken voorafgaand aan de start van de studiebehandeling of een actieve infectie die, naar de mening van de onderzoeker, de veiligheid van de patiënt kan beïnvloeden
  • Positief testresultaat voor humaan immunodeficiëntievirus (HIV)
  • Actieve hepatitis B of hepatitis C
  • Voorafgaande behandeling met CD137-agonisten of immuuncheckpoint-blokkadetherapieën, anti-CTLA-4-, anti-TIGIT-, anti-PD-1- en anti-PD-L1-therapeutische antilichamen
  • Behandeling met een onderzoekstherapie voorafgaand aan de start van de studiebehandeling
  • Slechte perifere veneuze toegang
  • Eerdere allogene stamcel- of solide orgaantransplantatie
  • Gelijktijdige deelname aan een ander therapeutisch klinisch onderzoek

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Atezolizumab + Tiragolumab + Pc
Deelnemers krijgen atezolizumab en tiragolumab op dag 1 van elke cyclus van 21 dagen tijdens het onderzoek, gevolgd door paclitaxel en cisplatine op dag 1 van elke cyclus van 21 dagen tot ziekteprogressie, verlies van klinisch voordeel of onaanvaardbare toxiciteit tijdens de inductiebehandelingsfase.
Geneesmiddel: Atezolizumab
Atezolizumab in een vaste dosis van 1200 milligram (mg) toegediend via intraveneuze (IV) infusie elke 3 weken (Q3W) op dag 1 van elke cyclus van 21 dagen.
Andere namen:
  • Tecentriq
Geneesmiddel: Tiragolumab
Tiragolumab in een vaste dosis van 600 mg toegediend via intraveneuze infusie elke 3e kwartaal op dag 1 van elke cyclus van 21 dagen.
Andere namen:
  • MTIG7192A
Geneesmiddel: Paclitaxel
Paclitaxel 175 mg/m^2 toegediend via intraveneuze infusie op dag 1 van elke cyclus van 21 dagen gedurende 6 cycli.
Geneesmiddel: Cisplatine
Cisplatine 60-80 mg/m^2 toegediend via intraveneuze infusie op dag 1 van elke cyclus van 21 dagen gedurende 6 cycli.
Placebo-vergelijker: Placebo + computer
Deelnemers krijgen atezolizumab, overeenkomend met placebo, en tiragolumab, overeenkomend met placebo, op dag 1 van elke cyclus van 21 dagen tijdens het onderzoek, gevolgd door paclitaxel en cisplatine op dag 1 van elke cyclus van 21 dagen tot ziekteprogressie, verlies van klinisch voordeel of onaanvaardbare toxiciteit, tijdens de studie. inductie behandelfase.
Geneesmiddel: Paclitaxel
Paclitaxel 175 mg/m^2 toegediend via intraveneuze infusie op dag 1 van elke cyclus van 21 dagen gedurende 6 cycli.
Geneesmiddel: Cisplatine
Cisplatine 60-80 mg/m^2 toegediend via intraveneuze infusie op dag 1 van elke cyclus van 21 dagen gedurende 6 cycli.
Geneesmiddel: Atezolizumab Matching Placebo
Atezolizumab overeenkomend met placebo toegediend via intraveneuze infusie, Q3W op dag 1 van elke cyclus van 21 dagen.
Geneesmiddel: Tiragolumab Matching Placebo
Tiragolumab overeenkomend met placebo toegediend via intraveneuze infusie, Q3W op dag 1 van elke cyclus van 21 dagen.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Independent Review Facility (IRF)-Assessed Progression-free Survival (PFS)
Tijdsspanne: 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)
Tijdsspanne: 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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Investigator-assessed PFS
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Hoffmann-La Roche

Onderzoekers

  • Studie directeur: Clinical Trials, Hoffmann-La Roche

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

30 oktober 2020

Primaire voltooiing (Werkelijk)

13 februari 2023

Studie voltooiing (Werkelijk)

28 augustus 2025

Studieregistratiedata

Eerst ingediend

3 september 2020

Eerst ingediend dat voldeed aan de QC-criteria

3 september 2020

Eerst geplaatst (Werkelijk)

7 september 2020

Updates van studierecords

Laatste update geplaatst (Werkelijk)

27 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

4 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • YO42138

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

Gekwalificeerde onderzoekers kunnen toegang vragen tot gegevens op individueel patiëntniveau via het platform voor het aanvragen van klinische onderzoeksgegevens (www.vivli.org). Meer details over de criteria van Roche voor in aanmerking komende studies zijn hier beschikbaar (https://vivli.org/ourmember/roche/). Zie hier (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm) voor meer informatie over het wereldwijde beleid van Roche inzake het delen van klinische informatie en hoe u toegang kunt krijgen tot verwante klinische onderzoeksdocumenten.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Ja

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren