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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04665843




Registration number
NCT04665843
Ethics application status
Date submitted
7/12/2020
Date registered
14/12/2020

Titles & IDs
Public title
A Study of Atezolizumab Plus Tiragolumab and Atezolizumab Plus Placebo as First-Line Treatment in Participants With Recurrent/Metastatic PD-L1 Positive Squamous Cell Carcinoma of the Head and Neck
Scientific title
A Phase II, Randomized, Double Blind Study of Atezolizumab Plus Tiragolumab and Atezolizumab Plus Placebo as First-Line Treatment in Patients With Recurrent/Metastatic PD-L1 Positive Squamous Cell Carcinoma of the Head and Neck
Secondary ID [1] 0 0
2020-002852-19
Secondary ID [2] 0 0
BO42533
Universal Trial Number (UTN)
Trial acronym
SKYSCRAPER-09
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Squamous Cell Carcinoma of Head and Neck 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
Head and neck

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

Experimental: Atezolizumab + Tiragolumab - Participants will receive atezolizumab followed by tiragolumab every three weeks (Q3W) on Day 1 of each 21-day cycle.

Placebo comparator: Atezolizumab + Placebo - Participants will receive atezolizumab followed by placebo Q3W on Day 1 of each 21-day cycle.


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

Treatment: Drugs: Tiragolumab
Tiragolumab at a fixed dose of 600 mg will be administered by IV infusion Q3W on Day 1 of each 21-day cycle.

Treatment: Drugs: Placebo
Placebo will be 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
Confirmed Objective Response Rate (ORR)
Timepoint [1] 0 0
Up to approximately 43 months
Secondary outcome [1] 0 0
Duration of Response (DOR)
Timepoint [1] 0 0
Up to approximately 43 months
Secondary outcome [2] 0 0
Progression-Free Survival (PFS)
Timepoint [2] 0 0
Up to approximately 43 months
Secondary outcome [3] 0 0
Overall Survival (OS)
Timepoint [3] 0 0
Up to approximately 43 months
Secondary outcome [4] 0 0
Progression-Free Survival Rate at 6 Months
Timepoint [4] 0 0
Month 6
Secondary outcome [5] 0 0
Overall Survival Rate at 6 Months and 12 Months
Timepoint [5] 0 0
Month 6, Month 12
Secondary outcome [6] 0 0
Time to Confirmed Deterioration (TTCD) in Patient-Reported Physical Functioning
Timepoint [6] 0 0
Up to approximately 43 months
Secondary outcome [7] 0 0
Percentage of Participants With Adverse Events (AEs)
Timepoint [7] 0 0
Up to approximately 43 months
Secondary outcome [8] 0 0
Minimum Serum Concentration (Cmin) of Atezolizumab
Timepoint [8] 0 0
Predose and 30 minutes postdose on Day 1 of Cycle 1 (each cycle is 21 days), predose on Day 1 of Cycles 2, 3, 4, 8, 12, 16 and at treatment discontinuation visit up to approximately 43 months
Secondary outcome [9] 0 0
Maximum Serum Concentration (Cmax) of Atezolizumab
Timepoint [9] 0 0
Predose and 30 minutes postdose on Day 1 of Cycle 1 (each cycle is 21 days), predose on Day 1 of Cycles 2, 3, 4, 8, 12, 16 and at treatment discontinuation visit up to approximately 43 months
Secondary outcome [10] 0 0
Cmin of Tiragolumab
Timepoint [10] 0 0
Predose and 30 minutes postdose on Day 1 of Cycle 1 (each cycle is 21 days), predose on Day 1 of Cycles 2, 3, 4, 8, 12, 16 and at treatment discontinuation visit up to approximately 43 months
Secondary outcome [11] 0 0
Cmax of Tiragolumab
Timepoint [11] 0 0
Predose and 30 minutes postdose on Day 1 of Cycle 1 (each cycle is 21 days), predose on Day 1 of Cycles 2, 3, 4, 8, 12, 16 and at treatment discontinuation visit up to approximately 43 months
Secondary outcome [12] 0 0
Number of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab
Timepoint [12] 0 0
From baseline up to approximately 43 months
Secondary outcome [13] 0 0
Number of Participants With ADAs to Tiragolumab
Timepoint [13] 0 0
From baseline up to approximately 43 months

Eligibility
Key inclusion criteria
Key

* Histologically or cytologically confirmed recurrent/metastatic SCCHN involving the oropharynx, oral cavity, larynx, or hypopharynx, that is considered incurable by local therapies
* Known results from human papillomavirus (HPV) status test for oropharyngeal carcinoma
* No prior systemic therapy for metastatic and/or recurrent SCCHN
* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
* Tumor PD-L1 expression as determined by PD-L1 immunohistochemistry assay
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* Life expectancy >=12 weeks

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Disease suitable for local therapy with curative intent
* Progressive or recurrent disease within 6 months of the last dose of curative intent systemic treatment for locally advanced SCCHN
* Rapidly progressing disease in the opinion of the treating investigator
* Grade >=2 unresolved toxicity related to surgery or other prior therapies
* Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
* History of leptomeningeal disease
* Active or history of autoimmune disease or immune deficiency
* History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
* History of additional malignancy other than SCCHN within 5 years prior to randomization
* Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-TIGIT, anti-PD-L1, and anti-PD-1 therapeutic antibodies
* Treatment with systemic immunostimulatory agents or systemic immunosuppressive medication
* Pregnancy or breastfeeding

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 2
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
2/03/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
25/02/2025
Actual
Sample size
Target
Accrual to date
Final
123
Recruitment in Australia
Recruitment state(s)
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
Maryland
Country [4] 0 0
United States of America
State/province [4] 0 0
Missouri
Country [5] 0 0
United States of America
State/province [5] 0 0
Tennessee
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas
Country [7] 0 0
Czechia
State/province [7] 0 0
Brno
Country [8] 0 0
Czechia
State/province [8] 0 0
Hradec Kralove
Country [9] 0 0
Czechia
State/province [9] 0 0
Praha 5
Country [10] 0 0
France
State/province [10] 0 0
Caen
Country [11] 0 0
France
State/province [11] 0 0
Lyon
Country [12] 0 0
France
State/province [12] 0 0
Montpellier
Country [13] 0 0
France
State/province [13] 0 0
Paris
Country [14] 0 0
France
State/province [14] 0 0
Pessac
Country [15] 0 0
France
State/province [15] 0 0
Vandoeuvre-Les-Nancy
Country [16] 0 0
Greece
State/province [16] 0 0
Athens
Country [17] 0 0
Greece
State/province [17] 0 0
Heraklion
Country [18] 0 0
Greece
State/province [18] 0 0
Thessaloniki
Country [19] 0 0
Hungary
State/province [19] 0 0
Gy?r
Country [20] 0 0
Hungary
State/province [20] 0 0
Pécs
Country [21] 0 0
Italy
State/province [21] 0 0
Lombardia
Country [22] 0 0
Italy
State/province [22] 0 0
Toscana
Country [23] 0 0
Korea, Republic of
State/province [23] 0 0
Seoul
Country [24] 0 0
New Zealand
State/province [24] 0 0
Auckland
Country [25] 0 0
New Zealand
State/province [25] 0 0
Christchurch
Country [26] 0 0
New Zealand
State/province [26] 0 0
Tauranga
Country [27] 0 0
New Zealand
State/province [27] 0 0
Wellington
Country [28] 0 0
Poland
State/province [28] 0 0
?ód?
Country [29] 0 0
Poland
State/province [29] 0 0
Bielsko- Biala
Country [30] 0 0
Poland
State/province [30] 0 0
Gdansk
Country [31] 0 0
Poland
State/province [31] 0 0
Lublin
Country [32] 0 0
Poland
State/province [32] 0 0
Poznan
Country [33] 0 0
Spain
State/province [33] 0 0
Barcelona
Country [34] 0 0
Spain
State/province [34] 0 0
Valencia
Country [35] 0 0
Taiwan
State/province [35] 0 0
Taichung
Country [36] 0 0
Taiwan
State/province [36] 0 0
Taipei City
Country [37] 0 0
Taiwan
State/province [37] 0 0
Zhongzheng Dist.
Country [38] 0 0
Thailand
State/province [38] 0 0
Bangkok
Country [39] 0 0
Thailand
State/province [39] 0 0
Songkhla
Country [40] 0 0
United Kingdom
State/province [40] 0 0
Cardiff
Country [41] 0 0
United Kingdom
State/province [41] 0 0
Glasgow
Country [42] 0 0
United Kingdom
State/province [42] 0 0
London
Country [43] 0 0
United Kingdom
State/province [43] 0 0
Sutton

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 Trials
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/NCT04665843