Register a trial

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04543617




Registration number
NCT04543617
Ethics application status
Date submitted
3/09/2020
Date registered
10/09/2020

Titles & IDs
Public title
A Study of Atezolizumab With or Without Tiragolumab in Participants With Unresectable Esophageal Squamous Cell Carcinoma Whose Cancers Have Not Progressed Following Definitive Concurrent Chemoradiotherapy
Scientific title
A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Atezolizumab With or Without Tiragolumab (Anti-TIGIT Antibody) in Patients With Unresectable Esophageal Squamous Cell Carcinoma Whose Cancers Have Not Progressed Following Definitive Concurrent Chemoradiotherapy
Secondary ID [1] 0 0
2020-001178-31
Secondary ID [2] 0 0
YO42137
Universal Trial Number (UTN)
Trial acronym
SKYSCRAPER-07
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Esophageal Squamous Cell Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Oesophageal (gullet)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tiragolumab
Treatment: Drugs - Atezolizumab
Treatment: Drugs - Tiragolumab Matching Placebo
Treatment: Drugs - Atezolizumab Matching Placebo

Experimental: Arm A: Tiragolumab + Atezolizumab - Participants will receive atezolizumab followed by tiragolumab.

Experimental: Arm B: Tiragolumab Placebo + Atezolizumab - Participants will receive atezolizumab followed by tiragolumab matching placebo.

Placebo comparator: Arm C: Tiragolumab Placebo + Atezolizumab Placebo - Participants will receive matching placebos to tiragolumab and atezolizumab.


Treatment: Drugs: Tiragolumab
Tiragolumab at a fixed dose of 600 milligrams (mg) administered by intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.

Treatment: Drugs: Atezolizumab
Atezolizumab at a fixed dose of 1200 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle.

Treatment: Drugs: Tiragolumab Matching Placebo
Tiragolumab matching placebo administered by IV infusion Q3W on Day 1 of each 21-day cycle.

Treatment: Drugs: Atezolizumab Matching Placebo
Atezolizumab matching placebo administered by IV infusion Q3W on Day 1 of each 21-day cycle.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Arm A vs Arm C: Investigator-Assessed Progression-Free Survival (PFS)
Timepoint [1] 0 0
From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 6 years)
Primary outcome [2] 0 0
Arm A vs Arm C: Overall Survival (OS)
Timepoint [2] 0 0
From randomization to death from any cause (up to approximately 6 years)
Primary outcome [3] 0 0
Arm B vs Arm C: OS
Timepoint [3] 0 0
From randomization to death from any cause (up to approximately 6 years)
Secondary outcome [1] 0 0
Arm B vs Arm C: Investigator-Assessed PFS
Timepoint [1] 0 0
From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 6 years)
Secondary outcome [2] 0 0
Arm A vs Arm B: Investigator-Assessed PFS
Timepoint [2] 0 0
From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 6 years)
Secondary outcome [3] 0 0
Arm A vs Arm B: OS
Timepoint [3] 0 0
From randomization to death from any cause (up to approximately 6 years)
Secondary outcome [4] 0 0
Independent Review Facility (IRF)-Assessed PFS
Timepoint [4] 0 0
From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 6 years)
Secondary outcome [5] 0 0
Investigator-Assessed Confirmed Objective Response Rate (ORR)
Timepoint [5] 0 0
From randomization up to approximately 6 years
Secondary outcome [6] 0 0
IRF-Assessed Confirmed ORR
Timepoint [6] 0 0
From randomization up to approximately 6 years
Secondary outcome [7] 0 0
Investigator-Assessed Duration of Objective Response (DOR)
Timepoint [7] 0 0
From the first occurrence of a documented confirmed objective response to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 6 years)
Secondary outcome [8] 0 0
IRF-Assessed DOR
Timepoint [8] 0 0
From the first occurrence of a documented confirmed objective response to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 6 years)
Secondary outcome [9] 0 0
Percentage of Participants With Clinically Meaningful Changes in Physical Functioning, Role Functioning, Quality of Life (QoL) as Measured by EORTC QLQ-C30
Timepoint [9] 0 0
Up to approximately 6 years
Secondary outcome [10] 0 0
Percentage of Participants With Clinically Meaningful Changes in Dysphagia as Measured by EORTC QLQ-OES18
Timepoint [10] 0 0
Up to approximately 6 years
Secondary outcome [11] 0 0
Percentage of Participants With Adverse Events (AEs)
Timepoint [11] 0 0
Up to approximately 6 years
Secondary outcome [12] 0 0
Serum Concentration of Tiragolumab
Timepoint [12] 0 0
Predose and postdose on Day 1 of Cycle 1 (each cycle=21 days) and predose on Day 1 of Cycles 2, 3, 4, 8, 12 and 16 and at treatment discontinuation (TD) visit (up to approximately 6 years)
Secondary outcome [13] 0 0
Serum Concentration of Atezolizumab
Timepoint [13] 0 0
Predose and postdose on Day 1 of Cycle 1 (each cycle=21 days) and predose on Day 1 of Cycles 2, 3, 4, 8, 12 and 16 and at TD visit (up to approximately 6 years)
Secondary outcome [14] 0 0
Percentage of Participants With Anti-drug Antibodies (ADAs) to Tiragolumab
Timepoint [14] 0 0
Predose on Day 1 of Cycles (each cycle=21 days) 1, 2, 3, 4, 8, 12 and 16 and at TD visit (up to approximately 6 years)
Secondary outcome [15] 0 0
Percentage of Participants With ADAs to Atezolizumab
Timepoint [15] 0 0
Predose on Day 1 of Cycles (each cycle=21 days) 1, 2, 3, 4, 8, 12 and 16 and at TD visit (up to approximately 6 years)

Eligibility
Key inclusion criteria
Key

* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* Histologically or cytologically confirmed diagnosis of squamous cell carcinoma of the esophagus
* Unresectable disease ineligible for curative surgery based on the documented opinion of the qualified medical, surgical or radiation oncologist prior to dCRT and is not expected to undergo tumor resection during the course of the study
* dCRT treatment according to regional oncology guidelines for esophageal cancer
* Representative archival formalin-fixed, paraffin-embedded (FFPE) tumor specimens collected prior to initiation of dCRT
* Adequate hematologic and end-organ function prior to randomization
* Women of childbearing potential must remain abstinent or use contraceptive methods with a failure rate of < 1% per year during the treatment period, for 5 months after the final dose of atezolizumab/placebo, and for 90 days after the final dose of tiragolumab/placebo, whichever is later
* Men must agree to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agree to refrain from donating sperm during the treatment period and for 90 days after the final dose of tiragolumab/placebo.

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, anti-PD-L1 and anti-TIGIT therapeutic antibodies
* Any unresolved toxicity of National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade = 2 from the prior chemoradiation therapy with the exception of irreversible and manageable hearing loss
* Prior allogeneic stem cell or solid organ transplantation
* Active or history of autoimmune disease or immune deficiency
* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis
* Malignancies other than esophageal cancer within 2 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
* Treatment with any other investigational agent, including epidermal growth factor receptor (EGFR) inhibitors, with therapeutic intent for esophageal cancer prior to randomization.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/09/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/03/2027
Actual
Sample size
Target
Accrual to date
Final
760
Recruitment in Australia
Recruitment state(s)
QLD,VIC,WA
Recruitment hospital [1] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [2] 0 0
Austin Health; Cancer Clinical Trial Centre - Heidelberg
Recruitment hospital [3] 0 0
St John of God Hospital; Bendat Cancer Centre - Subiaco
Recruitment postcode(s) [1] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [2] 0 0
3084 - Heidelberg
Recruitment postcode(s) [3] 0 0
6008 - Subiaco
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
Argentina
State/province [5] 0 0
Buenos Aires
Country [6] 0 0
Argentina
State/province [6] 0 0
Ciudad Autonoma de Buenos Aires
Country [7] 0 0
Argentina
State/province [7] 0 0
La Rioja
Country [8] 0 0
Austria
State/province [8] 0 0
Innsbruck
Country [9] 0 0
Austria
State/province [9] 0 0
Klagenfurt am Wörthersee
Country [10] 0 0
Austria
State/province [10] 0 0
Linz
Country [11] 0 0
Austria
State/province [11] 0 0
Wien
Country [12] 0 0
Belgium
State/province [12] 0 0
Edegem
Country [13] 0 0
Belgium
State/province [13] 0 0
Leuven
Country [14] 0 0
Belgium
State/province [14] 0 0
Liège
Country [15] 0 0
China
State/province [15] 0 0
Anyang City
Country [16] 0 0
China
State/province [16] 0 0
Beijing
Country [17] 0 0
China
State/province [17] 0 0
Bengbu
Country [18] 0 0
China
State/province [18] 0 0
Changsha CITY
Country [19] 0 0
China
State/province [19] 0 0
Changzhi City
Country [20] 0 0
China
State/province [20] 0 0
Changzhou
Country [21] 0 0
China
State/province [21] 0 0
Chengdu
Country [22] 0 0
China
State/province [22] 0 0
Chongqing City
Country [23] 0 0
China
State/province [23] 0 0
Chongqing
Country [24] 0 0
China
State/province [24] 0 0
Fuzhou
Country [25] 0 0
China
State/province [25] 0 0
Guangzhou City
Country [26] 0 0
China
State/province [26] 0 0
Guangzhou
Country [27] 0 0
China
State/province [27] 0 0
Hangzhou
Country [28] 0 0
China
State/province [28] 0 0
Jiangsu Sheng
Country [29] 0 0
China
State/province [29] 0 0
Jieyang City
Country [30] 0 0
China
State/province [30] 0 0
Jinan
Country [31] 0 0
China
State/province [31] 0 0
Jining
Country [32] 0 0
China
State/province [32] 0 0
Lianyungang
Country [33] 0 0
China
State/province [33] 0 0
Lishui City
Country [34] 0 0
China
State/province [34] 0 0
Luoyang City
Country [35] 0 0
China
State/province [35] 0 0
Nanjing City
Country [36] 0 0
China
State/province [36] 0 0
Shanghai City
Country [37] 0 0
China
State/province [37] 0 0
Shanghai
Country [38] 0 0
China
State/province [38] 0 0
Shantou
Country [39] 0 0
China
State/province [39] 0 0
Shenyang
Country [40] 0 0
China
State/province [40] 0 0
Shenzhen City
Country [41] 0 0
China
State/province [41] 0 0
Shijiazhuang
Country [42] 0 0
China
State/province [42] 0 0
Tianjin
Country [43] 0 0
China
State/province [43] 0 0
Wuhan City
Country [44] 0 0
China
State/province [44] 0 0
Wuhan
Country [45] 0 0
China
State/province [45] 0 0
Xiamen
Country [46] 0 0
China
State/province [46] 0 0
Xinxiang City
Country [47] 0 0
China
State/province [47] 0 0
Xuzhou
Country [48] 0 0
China
State/province [48] 0 0
Yangzhou City
Country [49] 0 0
China
State/province [49] 0 0
Zhejiang
Country [50] 0 0
France
State/province [50] 0 0
Brest
Country [51] 0 0
France
State/province [51] 0 0
Dijon
Country [52] 0 0
France
State/province [52] 0 0
Lille
Country [53] 0 0
France
State/province [53] 0 0
Lyon
Country [54] 0 0
France
State/province [54] 0 0
Marseille
Country [55] 0 0
France
State/province [55] 0 0
Nice
Country [56] 0 0
France
State/province [56] 0 0
Paris
Country [57] 0 0
France
State/province [57] 0 0
Pessac
Country [58] 0 0
France
State/province [58] 0 0
Poitiers
Country [59] 0 0
France
State/province [59] 0 0
Toulouse
Country [60] 0 0
Germany
State/province [60] 0 0
Essen
Country [61] 0 0
Germany
State/province [61] 0 0
Göttingen
Country [62] 0 0
Germany
State/province [62] 0 0
Leipzig
Country [63] 0 0
Germany
State/province [63] 0 0
Magdeburg
Country [64] 0 0
Germany
State/province [64] 0 0
Marburg
Country [65] 0 0
Germany
State/province [65] 0 0
Regensburg
Country [66] 0 0
Greece
State/province [66] 0 0
Athens
Country [67] 0 0
Greece
State/province [67] 0 0
Heraklion
Country [68] 0 0
Greece
State/province [68] 0 0
Thessaloniki
Country [69] 0 0
Hungary
State/province [69] 0 0
Pécs
Country [70] 0 0
Hungary
State/province [70] 0 0
Szeged
Country [71] 0 0
Israel
State/province [71] 0 0
Jerusalem
Country [72] 0 0
Israel
State/province [72] 0 0
Rambam
Country [73] 0 0
Israel
State/province [73] 0 0
Tel Aviv
Country [74] 0 0
Italy
State/province [74] 0 0
Campania
Country [75] 0 0
Italy
State/province [75] 0 0
Emilia-Romagna
Country [76] 0 0
Italy
State/province [76] 0 0
Friuli-Venezia Giulia
Country [77] 0 0
Italy
State/province [77] 0 0
Veneto
Country [78] 0 0
Japan
State/province [78] 0 0
Aichi
Country [79] 0 0
Japan
State/province [79] 0 0
Chiba
Country [80] 0 0
Japan
State/province [80] 0 0
Hiroshima
Country [81] 0 0
Japan
State/province [81] 0 0
Hyogo
Country [82] 0 0
Japan
State/province [82] 0 0
Kanagawa
Country [83] 0 0
Japan
State/province [83] 0 0
Miyagi
Country [84] 0 0
Japan
State/province [84] 0 0
Niigata
Country [85] 0 0
Japan
State/province [85] 0 0
Osaka
Country [86] 0 0
Japan
State/province [86] 0 0
Saitama
Country [87] 0 0
Japan
State/province [87] 0 0
Shizuoka
Country [88] 0 0
Japan
State/province [88] 0 0
Tokyo
Country [89] 0 0
Kenya
State/province [89] 0 0
Eldoret
Country [90] 0 0
Kenya
State/province [90] 0 0
Nairobi
Country [91] 0 0
Korea, Republic of
State/province [91] 0 0
Daegu
Country [92] 0 0
Korea, Republic of
State/province [92] 0 0
Gyeonggi-do
Country [93] 0 0
Korea, Republic of
State/province [93] 0 0
Jeollanam-do
Country [94] 0 0
Korea, Republic of
State/province [94] 0 0
Seoul
Country [95] 0 0
Morocco
State/province [95] 0 0
FES
Country [96] 0 0
Morocco
State/province [96] 0 0
Marrakech
Country [97] 0 0
Morocco
State/province [97] 0 0
Rabat
Country [98] 0 0
New Zealand
State/province [98] 0 0
Tauranga
Country [99] 0 0
Poland
State/province [99] 0 0
Bydgoszcz
Country [100] 0 0
Poland
State/province [100] 0 0
Lublin
Country [101] 0 0
Poland
State/province [101] 0 0
Olsztyn
Country [102] 0 0
Poland
State/province [102] 0 0
Pozna?
Country [103] 0 0
Poland
State/province [103] 0 0
Warszawa
Country [104] 0 0
Poland
State/province [104] 0 0
Wroc?aw
Country [105] 0 0
Portugal
State/province [105] 0 0
Coimbra
Country [106] 0 0
Portugal
State/province [106] 0 0
Porto
Country [107] 0 0
Russian Federation
State/province [107] 0 0
Krasnodar
Country [108] 0 0
Russian Federation
State/province [108] 0 0
Moskovskaja Oblast
Country [109] 0 0
Russian Federation
State/province [109] 0 0
Sankt Petersburg
Country [110] 0 0
Russian Federation
State/province [110] 0 0
Tatarstan
Country [111] 0 0
Russian Federation
State/province [111] 0 0
Udmurtija
Country [112] 0 0
Russian Federation
State/province [112] 0 0
Novosibirsk
Country [113] 0 0
Russian Federation
State/province [113] 0 0
Tomsk
Country [114] 0 0
South Africa
State/province [114] 0 0
Johannesburg
Country [115] 0 0
South Africa
State/province [115] 0 0
Polokwane
Country [116] 0 0
South Africa
State/province [116] 0 0
Port Elizabeth
Country [117] 0 0
South Africa
State/province [117] 0 0
Pretoria
Country [118] 0 0
Spain
State/province [118] 0 0
Asturias
Country [119] 0 0
Spain
State/province [119] 0 0
LA Coruña
Country [120] 0 0
Spain
State/province [120] 0 0
Barcelona
Country [121] 0 0
Spain
State/province [121] 0 0
Cordoba
Country [122] 0 0
Spain
State/province [122] 0 0
Madrid
Country [123] 0 0
Spain
State/province [123] 0 0
Malaga
Country [124] 0 0
Spain
State/province [124] 0 0
Valencia
Country [125] 0 0
Switzerland
State/province [125] 0 0
Bern
Country [126] 0 0
Switzerland
State/province [126] 0 0
Zürich
Country [127] 0 0
Taiwan
State/province [127] 0 0
Kaoisung
Country [128] 0 0
Taiwan
State/province [128] 0 0
Taichung
Country [129] 0 0
Taiwan
State/province [129] 0 0
Tainan
Country [130] 0 0
Taiwan
State/province [130] 0 0
Taipei City
Country [131] 0 0
Taiwan
State/province [131] 0 0
Zhongzheng Dist.
Country [132] 0 0
Thailand
State/province [132] 0 0
Bangkok
Country [133] 0 0
Thailand
State/province [133] 0 0
Songkhla
Country [134] 0 0
Turkey
State/province [134] 0 0
Adana
Country [135] 0 0
Turkey
State/province [135] 0 0
Ankara
Country [136] 0 0
Turkey
State/province [136] 0 0
Erzurum
Country [137] 0 0
Turkey
State/province [137] 0 0
Istanbul
Country [138] 0 0
Turkey
State/province [138] 0 0
Kadiköy
Country [139] 0 0
Turkey
State/province [139] 0 0
Malatya
Country [140] 0 0
Turkey
State/province [140] 0 0
Van
Country [141] 0 0
Ukraine
State/province [141] 0 0
Kharkiv Governorate
Country [142] 0 0
Ukraine
State/province [142] 0 0
KIEV Governorate
Country [143] 0 0
Ukraine
State/province [143] 0 0
Podolia Governorate
Country [144] 0 0
Ukraine
State/province [144] 0 0
Sumy
Country [145] 0 0
United Kingdom
State/province [145] 0 0
Bournemouth
Country [146] 0 0
United Kingdom
State/province [146] 0 0
Cambridge
Country [147] 0 0
United Kingdom
State/province [147] 0 0
London
Country [148] 0 0
United Kingdom
State/province [148] 0 0
Sutton
Country [149] 0 0
United Kingdom
State/province [149] 0 0
Wirral
Country [150] 0 0
United Kingdom
State/province [150] 0 0
Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trial
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04543617