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En studie av Atezolizumab Plus Tiragolumab i kombination med paklitaxel och cisplatin jämfört med paklitaxel och cisplatin som förstahandsbehandling hos deltagare med inoperabelt lokalt avancerat, icke-opererbart återkommande eller metastaserande matstrupscancer (SKYSCRAPER-08)

4 augusti 2026 uppdaterad av: Hoffmann-La Roche

En fas III, randomiserad, dubbelblind, placebokontrollerad studie av Atezolizumab Plus Tiragolumab i kombination med paklitaxel och cisplatin jämfört med paklitaxel och cisplatin som första linjens behandling hos patienter med inoperabelt lokalt avancerat, icke-operabelt återkommande eller metastaserande esquamsofag med karcinom.

Syftet med denna studie är att utvärdera effektiviteten och säkerheten av atezolizumab plus tiragolumab i kombination med paklitaxel och cisplatin (PC) jämfört med atezolizumab matchande placebo plus tiragolumab matchande placebo plus PC som förstahandsbehandling hos deltagare med icke-operabelt lokalt framskridet, icke-opererbart återfall. , eller metastaserande esofaguskarcinom (EC). Deltagarna kommer att randomiseras i förhållandet 1:1 för att få en av följande behandlingsregimer under induktionsfasen:

Arm A: Atezolizumab plus Tiragolumab och PC Arm B: Atezolizumab placebo plus Tiragolumab placebo och PC Efter induktionsfasen kommer deltagarna att fortsätta underhållsbehandlingen med antingen atezolizumab plus tiragolumab (arm A) eller atezolizumab matchande placebo plus tiragolumab matchande placebo (arm B).

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

461

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Beskrivning

Viktiga inkluderingskriterier:

  • Histologiskt bekräftad EC
  • Inoperabel lokalt avancerad, icke-opererbar återkommande eller metastaserande sjukdom
  • Mätbar sjukdom per svarsutvärderingskriterier i solida tumörer version 1.1 (RECIST v1.1)
  • Eastern Cooperative Oncology Group (ECOG) prestationsstatus på 0 eller 1
  • Tillräcklig hematologisk funktion och ändorgansfunktion
  • Kvinnliga deltagare måste vara villiga att undvika graviditet och avstå från att donera ägg under behandlingsperioden och i 90 dagar efter den sista dosen
  • Manliga deltagare med partners i fertil ålder måste förbinda sig att använda två preventivmetoder och får inte donera spermier under studietiden och 90 dagar efter den sista dosen

Viktiga uteslutningskriterier:

  • Palliativ strålbehandling för EC inom 4 veckor före påbörjad studiebehandling
  • Bevis på fullständig esofagusobstruktion som inte är mottaglig för behandling
  • Symtomatiska, obehandlade eller aktivt fortskridande metastaser från centrala nervsystemet (CNS).
  • Okontrollerad tumörrelaterad smärta, okontrollerad pleurautgjutning, perikardiell utgjutning eller ascites som kräver återkommande dräneringsprocedurer
  • Aktiv eller historia av autoimmun sjukdom eller immunbrist eller leptomeningeal sjukdom
  • Historik av idiopatisk lungfibros, organiserande lunginflammation, läkemedelsinducerad pneumonit eller idiopatisk pneumonit, eller tecken på aktiv pneumonit
  • Andra maligniteter än EC inom 2 år före screening med en försumbar risk för metastasering eller död, adekvat behandlad med förväntat kurativt resultat
  • Allvarlig infektion inom 4 veckor innan studiebehandlingen påbörjas eller någon aktiv infektion som, enligt utredarens åsikt, kan påverka patientsäkerheten
  • Positivt testresultat för humant immunbristvirus (HIV)
  • Aktiv hepatit B eller hepatit C
  • Tidigare behandling med CD137-agonister eller immunkontrollpunktsblockadterapier, anti-CTLA-4, anti-TIGIT, anti-PD-1 och anti-PD-L1 terapeutiska antikroppar
  • Behandling med någon undersökningsterapi innan studiebehandlingen påbörjas
  • Dålig perifer venös åtkomst
  • Tidigare allogen stamcells- eller fasta organtransplantation
  • Samtidigt deltagande i en annan terapeutisk klinisk prövning

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Fyrdubbla

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Atezolizumab + Tiragolumab + PC
Deltagarna kommer att få atezolizumab och tiragolumab på dag 1 i varje 21-dagarscykel under studien följt av paklitaxel och cisplatin på dag 1 i varje 21-dagarscykel tills sjukdomsprogression, förlust av klinisk nytta eller oacceptabel toxicitet, under induktionsbehandlingsfasen.
Läkemedel: Atezolizumab
Atezolizumab i en fast dos på 1200 milligram (mg) administrerat som intravenös (IV) infusion var tredje vecka (Q3W) på dag 1 i varje 21-dagars cykel.
Andra namn:
  • Tecentriq
Läkemedel: Tiragolumab
Tiragolumab i en fast dos på 600 mg administrerat som IV-infusion varje Q3W på dag 1 i varje 21-dagarscykel.
Andra namn:
  • MTIG7192A
Läkemedel: Paklitaxel
Paklitaxel 175 mg/m^2 administrerat genom IV-infusion på dag 1 i varje 21-dagarscykel under 6 cykler.
Läkemedel: Cisplatin
Cisplatin 60-80 mg/m^2 administrerat genom IV-infusion på dag 1 i varje 21-dagarscykel under 6 cykler.
Placebo-jämförare: Placebo + PC
Deltagarna kommer att få atezolizumab matchande placebo och tiragolumab matchande placebo på dag 1 i varje 21-dagarscykel under studien följt av paklitaxel och cisplatin på dag 1 i varje 21-dagars cykel tills sjukdomsprogression, förlust av klinisk nytta eller oacceptabel toxicitet, under induktionsbehandlingsfas.
Läkemedel: Paklitaxel
Paklitaxel 175 mg/m^2 administrerat genom IV-infusion på dag 1 i varje 21-dagarscykel under 6 cykler.
Läkemedel: Cisplatin
Cisplatin 60-80 mg/m^2 administrerat genom IV-infusion på dag 1 i varje 21-dagarscykel under 6 cykler.
Läkemedel: Atezolizumab Matchande Placebo
Atezolizumab-matchande placebo administrerat som IV-infusion, Q3W på dag 1 av varje 21-dagarscykel.
Läkemedel: Tiragolumab Matchande Placebo
Tiragolumab matchande placebo administrerat som IV-infusion, Q3W på dag 1 av varje 21-dagars cykel.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Independent Review Facility (IRF)-Assessed Progression-free Survival (PFS)
Tidsram: 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)
Tidsram: 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)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Investigator-assessed PFS
Tidsram: 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)
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Hoffmann-La Roche

Utredare

  • Studierektor: Clinical Trials, Hoffmann-La Roche

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

30 oktober 2020

Primärt slutförande (Faktisk)

13 februari 2023

Avslutad studie (Faktisk)

28 augusti 2025

Studieregistreringsdatum

Först inskickad

3 september 2020

Först inskickad som uppfyllde QC-kriterierna

3 september 2020

Första postat (Faktisk)

7 september 2020

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

27 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

4 augusti 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • YO42138

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

Kvalificerade forskare kan begära tillgång till data på individuell patientnivå via plattformen för begäran om kliniska studier (www.vivli.org). Ytterligare information om Roches kriterier för kvalificerade studier finns här (https://vivli.org/ourmember/roche/). För ytterligare information om Roches globala policy för delning av klinisk information och hur man begär åtkomst till relaterade kliniska studiedokument, se här (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

produkt tillverkad i och exporterad från U.S.A.

Ja

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