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Eine Studie zu Atezolizumab plus Tiragolumab in Kombination mit Paclitaxel und Cisplatin im Vergleich zu Paclitaxel und Cisplatin als Erstlinienbehandlung bei Teilnehmern mit nicht resezierbarem lokal fortgeschrittenem, nicht resezierbarem rezidivierendem oder metastasiertem Ösophaguskarzinom (SKYSCRAPER-08)

4. August 2026 aktualisiert von: Hoffmann-La Roche

Eine randomisierte, doppelblinde, placebokontrollierte Phase-III-Studie zu Atezolizumab plus Tiragolumab in Kombination mit Paclitaxel und Cisplatin im Vergleich zu Paclitaxel und Cisplatin als Erstlinienbehandlung bei Patienten mit nicht resezierbarem, lokal fortgeschrittenem, nicht resezierbarem rezidivierendem oder metastasiertem Plattenepithelkarzinom des Ösophagus

Der Zweck dieser Studie ist die Bewertung der Wirksamkeit und Sicherheit von Atezolizumab plus Tiragolumab in Kombination mit Paclitaxel und Cisplatin (PC) im Vergleich zu Atezolizumab mit passendem Placebo plus Tiragolumab mit passendem Placebo plus PC als Erstlinienbehandlung bei Teilnehmern mit inoperablem lokal fortgeschrittenem, inoperablem Rezidiv , oder metastasierendes Ösophaguskarzinom (EC). Die Teilnehmer werden im Verhältnis 1:1 randomisiert und erhalten während der Induktionsphase eines der folgenden Behandlungsschemata:

Arm A: Atezolizumab plus Tiragolumab und PC Arm B: Atezolizumab-Placebo plus Tiragolumab-Placebo und PC Nach der Induktionsphase setzen die Teilnehmer die Erhaltungstherapie entweder mit Atezolizumab plus Tiragolumab (Arm A) oder Atezolizumab-passendes Placebo plus Tiragolumab-passendes Placebo (Arm B) fort.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

461

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • 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
  • Südkorea
      • Daegu, Südkorea, 41404
        • Kyungpook National University Chilgok Hospital
      • Goyang-si, Südkorea, 10408
        • National Cancer Center
      • Seongnam-si, Südkorea, 13605
        • Seoul National University Bundang Hospital
      • Seoul, Südkorea, 05505
        • Asan Medical Center
      • Seoul, Südkorea, 06351
        • Samsung Medical Center
      • Seoul, Südkorea, 03722
        • Severance Hospital, Yonsei University Health System
      • Seoul, Südkorea, 08308
        • Korea University Guro 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
  • 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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Wichtige Einschlusskriterien:

  • Histologisch bestätigte EC
  • Nicht resezierbare, lokal fortgeschrittene, nicht resezierbare rezidivierende oder metastasierende Erkrankung
  • Bewertungskriterien für messbare Krankheit pro Ansprechen bei soliden Tumoren Version 1.1 (RECIST v1.1)
  • Leistungsstatus der Eastern Cooperative Oncology Group (ECOG) von 0 oder 1
  • Angemessene hämatologische und Endorganfunktion
  • Teilnehmerinnen müssen bereit sein, eine Schwangerschaft zu vermeiden und während der Behandlungsdauer und 90 Tage nach der letzten Dosis keine Eizellen zu spenden
  • Männliche Teilnehmer mit gebärfähigen Partnern müssen sich zur Anwendung von zwei Verhütungsmethoden verpflichten und dürfen während der Studiendauer und 90 Tage nach der letzten Dosis kein Sperma spenden

Wichtige Ausschlusskriterien:

  • Palliative Strahlenbehandlung für EC innerhalb von 4 Wochen vor Beginn der Studienbehandlung
  • Nachweis einer vollständigen Ösophagusobstruktion, die einer Behandlung nicht zugänglich ist
  • Symptomatische, unbehandelte oder aktiv fortschreitende Metastasen des Zentralnervensystems (ZNS).
  • Unkontrollierte tumorbedingte Schmerzen, unkontrollierter Pleuraerguss, Perikarderguss oder Aszites, die wiederholte Drainageverfahren erfordern
  • Aktive oder Vorgeschichte einer Autoimmunerkrankung oder Immunschwäche oder leptomeningealen Erkrankung
  • Geschichte der idiopathischen Lungenfibrose, organisierende Pneumonie, arzneimittelinduzierte Pneumonitis oder idiopathische Pneumonitis oder Anzeichen einer aktiven Pneumonitis
  • Andere Malignome als EC innerhalb von 2 Jahren vor dem Screening mit einem vernachlässigbaren Metastasierungs- oder Todesrisiko, die mit erwartetem Heilungsergebnis angemessen behandelt werden
  • Schwere Infektion innerhalb von 4 Wochen vor Beginn der Studienbehandlung oder jede aktive Infektion, die nach Ansicht des Prüfarztes die Patientensicherheit beeinträchtigen könnte
  • Positives Testergebnis für Human Immunodeficiency Virus (HIV)
  • Aktive Hepatitis B oder Hepatitis C
  • Vorherige Behandlung mit CD137-Agonisten oder Immun-Checkpoint-Blockade-Therapien, therapeutischen Anti-CTLA-4-, Anti-TIGIT-, Anti-PD-1- und Anti-PD-L1-Antikörpern
  • Behandlung mit einer Prüftherapie vor Beginn der Studienbehandlung
  • Schlechter peripherer venöser Zugang
  • Vorherige allogene Stammzell- oder solide Organtransplantation
  • Gleichzeitige Teilnahme an einer anderen therapeutischen klinischen Studie

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Atezolizumab + Tiragolumab + PC
Die Teilnehmer erhalten Atezolizumab und Tiragolumab an Tag 1 jedes 21-tägigen Zyklus während der Studie, gefolgt von Paclitaxel und Cisplatin an Tag 1 jedes 21-tägigen Zyklus bis zum Fortschreiten der Krankheit, Verlust des klinischen Nutzens oder inakzeptabler Toxizität während der Induktionsphase.
Arzneimittel: Atezolizumab
Atezolizumab in einer festen Dosis von 1200 Milligramm (mg), verabreicht als intravenöse (IV) Infusion alle 3 Wochen (Q3W) an Tag 1 jedes 21-tägigen Zyklus.
Andere Namen:
  • Tecentriq
Arzneimittel: Tiragolumab
Tiragolumab in einer festen Dosis von 600 mg, verabreicht als intravenöse Infusion alle 3 Wochen an Tag 1 jedes 21-tägigen Zyklus.
Andere Namen:
  • MTIG7192A
Arzneimittel: Paclitaxel
Paclitaxel 175 mg/m², verabreicht als IV-Infusion an Tag 1 jedes 21-Tage-Zyklus für 6 Zyklen.
Arzneimittel: Cisplatin
Cisplatin 60-80 mg/m^2, verabreicht als IV-Infusion an Tag 1 jedes 21-Tage-Zyklus für 6 Zyklen.
Placebo-Komparator: Placebo + PC
Die Teilnehmer erhalten an Tag 1 jedes 21-tägigen Zyklus während der Studie Atezolizumab-passendes Placebo und Tiragolumab-passendes Placebo, gefolgt von Paclitaxel und Cisplatin an Tag 1 jedes 21-tägigen Zyklus bis zum Fortschreiten der Krankheit, Verlust des klinischen Nutzens oder inakzeptabler Toxizität während der Studie Induktionsbehandlungsphase.
Arzneimittel: Paclitaxel
Paclitaxel 175 mg/m², verabreicht als IV-Infusion an Tag 1 jedes 21-Tage-Zyklus für 6 Zyklen.
Arzneimittel: Cisplatin
Cisplatin 60-80 mg/m^2, verabreicht als IV-Infusion an Tag 1 jedes 21-Tage-Zyklus für 6 Zyklen.
Arzneimittel: Atezolizumab passendes Placebo
Atezolizumab passend zu Placebo, verabreicht als IV-Infusion, Q3W an Tag 1 jedes 21-tägigen Zyklus.
Arzneimittel: Tiragolumab, passendes Placebo
Tiragolumab, das Placebo entspricht, verabreicht als IV-Infusion, Q3W an Tag 1 jedes 21-Tage-Zyklus.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Independent Review Facility (IRF)-Assessed Progression-free Survival (PFS)
Zeitfenster: 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)
Zeitfenster: 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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Investigator-assessed PFS
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Hoffmann-La Roche

Ermittler

  • Studienleiter: Clinical Trials, Hoffmann-La Roche

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

30. Oktober 2020

Primärer Abschluss (Tatsächlich)

13. Februar 2023

Studienabschluss (Tatsächlich)

28. August 2025

Studienanmeldedaten

Zuerst eingereicht

3. September 2020

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

3. September 2020

Zuerst gepostet (Tatsächlich)

7. September 2020

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

27. August 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

4. August 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • YO42138

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

Qualifizierte Forscher können über die Datenanforderungsplattform für klinische Studien (www.vivli.org) Zugang zu individuellen Patientendaten beantragen. Weitere Einzelheiten zu den Roche-Kriterien für förderfähige Studien finden Sie hier (https://vivli.org/ourmember/roche/). Weitere Einzelheiten zu Roches Global Policy on the Sharing of Clinical Information und zur Beantragung des Zugriffs auf zugehörige klinische Studiendokumente finden Sie hier (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Ja

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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