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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04543617
Ethics application status
Date submitted
3/09/2020
Date registered
10/09/2020
Date last updated
13/04/2021

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 50 months)
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 50 months)
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 50 months)
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 50 months)
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 50 months)
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 50 months)
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 50 months)
Secondary outcome [5] 0 0
Investigator-Assessed Confirmed Objective Response Rate (ORR)
Timepoint [5] 0 0
From randomization up to approximately 50 months
Secondary outcome [6] 0 0
IRF-Assessed Confirmed ORR
Timepoint [6] 0 0
From randomization up to approximately 50 months
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 50 months)
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 50 months)
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 - Clinically meaningful changes in physical functioning, role functioning, global health status (GHS)/QoL as measured by the European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 Questionnaire (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 and QoL, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties) within the previous week. Functioning and symptoms items are scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much. GHS and QoL items are scored on a 7-point scale: 1=Very poor, 2, 3, 4, 5, 6, 7=Excellent. Scores will be linearly transformed to a range of 0 to 100, with higher scores (i.e. closer to 100) reflecting better functioning, better GHS/QoL, and worse symptoms.
Timepoint [9] 0 0
Up to approximately 50 months
Secondary outcome [10] 0 0
Percentage of Participants With Clinically Meaningful Changes in Dysphagia as Measured by EORTC QLQ-OES18 - Clinically meaningful changes in dysphagia as measured by the EORTC Quality of Life-Esophageal Cancer, Module 18 Questionnaire (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 is scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much. Scores will be linearly transformed to a range of 0 to 100, with higher transformed scores (i.e. closer to 100) reflecting worse symptoms.
Timepoint [10] 0 0
Up to approximately 50 months
Secondary outcome [11] 0 0
Percentage of Participants With Adverse Events (AEs)
Timepoint [11] 0 0
Up to approximately 50 months
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 50 months)
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 50 months)
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 50 months)
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 50 months)

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 and is not expected to
undergo tumor resection during the course of the study

- Definitive concurrent chemoradiation treatment according to regional oncology
guidelines for esophageal cancer

- Representative archival formalin-fixed, paraffin-embedded (FFPE) tumor specimens,
collected prior to initiation of definitive concurrent chemoradiotherapy

- Adequate hematologic and end-organ function

- 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
Gender
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Connecticut
Country [3] 0 0
United States of America
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Florida
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Illinois
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Kansas
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North Carolina
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Pennsylvania
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United Kingdom
State/province [171] 0 0
Sutton
Country [172] 0 0
United Kingdom
State/province [172] 0 0
Swansea
Country [173] 0 0
United Kingdom
State/province [173] 0 0
Wirral
Country [174] 0 0
United Kingdom
State/province [174] 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
The purpose of this study is to evaluate the efficacy and safety of tiragolumab plus
atezolizumab compared with placebo in participants with unresectable esophageal squamous cell
carcinoma (or those who are unable or unwilling to undergo surgery) and whose cancers have
not progressed following definitive concurrent chemoradiotherapy. Participants will be
randomized in a 1:1:1 ratio to receive either tiragolumab plus atezolizumab (Arm A),
tiragolumab matching placebo plus atezolizumab (Arm B), or double placebo (Arm C).
Trial website
https://clinicaltrials.gov/show/NCT04543617
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
Reference Study ID Number: YO42137 www.roche.com/about_roche/roche_worldwide.htm
Address 0 0
Country 0 0
Phone 0 0
888-662-6728 (U.S. Only)
Fax 0 0
Email 0 0
global-roche-genentech-trials@gene.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04543617