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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04300647




Registration number
NCT04300647
Ethics application status
Date submitted
6/03/2020
Date registered
9/03/2020

Titles & IDs
Public title
A Study of Tiragolumab Plus Atezolizumab and Atezolizumab Monotherapy in Participants With Metastatic and/or Recurrent PD-L1-Positive Cervical Cancer
Scientific title
A Phase II, Safety, and Efficacy Study of Tiragolumab Plus Atezolizumab and Atezolizumab Monotherapy in Patients With Metastatic and/or Recurrent PD-L1-Positive Cervical Cancer
Secondary ID [1] 0 0
2019-004895-21
Secondary ID [2] 0 0
WO42017
Universal Trial Number (UTN)
Trial acronym
SKYSCRAPER-04
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cervical Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)
Cancer 0 0 0 0
Cervical (cervix)

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

Experimental: Tiragolumab plus Atezolizumab - Participants will receive tiragolumab and atezolizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.

Experimental: Atezolizumab - Participants will receive atezolizumab monotherapy until unacceptable toxicity or loss of clinical benefit as determined by the investigator.


Treatment: Drugs: Tiragolumab
Tiragolumab at a fixed dose of 600 milligrams (mg) will be 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 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
Independent Review Committee (IRC)-Assessed Objective Response Rate (ORR)
Timepoint [1] 0 0
From randomization up to approximately 36 months
Secondary outcome [1] 0 0
Percentage of Participants With Adverse Events
Timepoint [1] 0 0
Up to 36 months
Secondary outcome [2] 0 0
IRC-Assessed Duration of Response (DOR)
Timepoint [2] 0 0
First occurrence of a documented objective response to the date of disease progression or death from any cause, whichever occurs first (up to approximately 36 months)
Secondary outcome [3] 0 0
IRC-Assessed Disease Control Rate (DCR)
Timepoint [3] 0 0
From randomization up to approximately 36 months
Secondary outcome [4] 0 0
Investigator-Assessed Best Clinical Response (BCR) Rate
Timepoint [4] 0 0
From randomization up to approximately 36 months
Secondary outcome [5] 0 0
Investigator-Assessed DOR
Timepoint [5] 0 0
First occurrence of a documented objective response to the date of disease progression or death from any cause, whichever occurs first (up to approximately 36 months)
Secondary outcome [6] 0 0
IRC-Assessed Progression-Free Survival (PFS)
Timepoint [6] 0 0
From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 36 months)
Secondary outcome [7] 0 0
IRC-Assessed PFS Rate at 6 Months
Timepoint [7] 0 0
At 6 months post-randomization
Secondary outcome [8] 0 0
Overall Survival (OS)
Timepoint [8] 0 0
From randomization to death from any cause (up to 36 months)
Secondary outcome [9] 0 0
OS Rate at 6 Months and 12 Months
Timepoint [9] 0 0
At 6 and 12 months post-randomization
Secondary outcome [10] 0 0
Minimum Serum Concentration (Cmin) of Tiragolumab
Timepoint [10] 0 0
Predose and 30 minutes postdose on Day 1 of Cycle 1 (each cycle is 21 days) and predose on Day 1 of Cycles 2, 3, 4, 8, 12 and 16 and at treatment discontinuation (TD) visit (up to 36 months)
Secondary outcome [11] 0 0
Maximum Serum Concentration (Cmax) of Tiragolumab
Timepoint [11] 0 0
Predose and 30 minutes postdose on Day 1 of Cycle 1 (each cycle is 21 days) and predose on Day 1 of Cycles 2, 3, 4, 8, 12 and 16 and at TD visit (up to 36 months)
Secondary outcome [12] 0 0
Cmin of Atezolizumab
Timepoint [12] 0 0
Predose and 30 minutes postdose on Day 1 of Cycle 1 (each cycle is 21 days) and predose on Day 1 of Cycles 2, 3, 4, 8, 12 and 16 and at TD visit (up to 36 months)
Secondary outcome [13] 0 0
Cmax of Atezolizumab
Timepoint [13] 0 0
Predose and 30 minutes postdose on Day 1 of Cycle 1 (each cycle is 21 days) and predose on Day 1 of Cycles 2, 3, 4, 8, 12 and 16 and at TD visit (up to 36 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 1, 2, 3, 4, 8, 12 and 16 (each cycle is 21 days) and at TD visit (up to 36 months)
Secondary outcome [15] 0 0
Percentage of Participants With ADAs to Atezolizumab
Timepoint [15] 0 0
Predose on Day 1 of Cycles 1, 2, 3, 4, 8, 12 and 16 (each cycle is 21 days) and at TD visit (up to 36 months)

Eligibility
Key inclusion criteria
* Histologically confirmed recurrent or persistent squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix after progression on or after 1-2 lines of prior systemic chemotherapy in the metastatic/recurrent setting that is not amenable to curative treatment with systemic chemotherapy, surgery, and/or radiotherapy
* Radiologically-measurable disease
* Eastern Cooperative Oncology Group (ECOG) performance Status of 0 or 1
* Cervical cancer tissue for study analysis (archival or fresh biopsy specimen)
* Life expectancy of at least 12 weeks
* Adequate hematologic and organ function
* Female of childbearing potential must be willing to comply with adequate contraception
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* Treatment with investigational therapy with therapeutic intent within 28 days prior to randomization
* Active or untreated central nervous system (CNS) or brain metastases
* Active or history of autoimmune disease or immune deficiency
* Active tuberculosis
* Known, clinically significant liver disease
* Severe infection per investigator judgement at the time of randomization or any active infection that, in the opinion of the investigator, could impact patient safety
* Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti-CTLA-4, anti-TIGIT, anti-PD-1, and anti-PD-L1 therapeutic antibodies
* Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to randomization
* Treatment with systemic immunosuppressive medications within 1 week prior to randomization or anticipation of need for systemic immunosuppressive medication during study
* Pregnant or breastfeeding woman
* Known hypersensitivity to any component of the tiragolumab or atezolizumab formulations

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
Open (masking not used)
Who is / are masked / blinded?



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
30/06/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/12/2024
Actual
Sample size
Target
Accrual to date
Final
172
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Mater Misericordiae Limited - South Brisbane
Recruitment postcode(s) [1] 0 0
4101 - South Brisbane
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Oregon
Country [5] 0 0
Brazil
State/province [5] 0 0
BA
Country [6] 0 0
Brazil
State/province [6] 0 0
GO
Country [7] 0 0
Brazil
State/province [7] 0 0
RS
Country [8] 0 0
Brazil
State/province [8] 0 0
SP
Country [9] 0 0
Canada
State/province [9] 0 0
Ontario
Country [10] 0 0
Canada
State/province [10] 0 0
Quebec
Country [11] 0 0
Costa Rica
State/province [11] 0 0
San José
Country [12] 0 0
France
State/province [12] 0 0
Lyon
Country [13] 0 0
France
State/province [13] 0 0
Marseille
Country [14] 0 0
France
State/province [14] 0 0
Montpellier
Country [15] 0 0
France
State/province [15] 0 0
Saint Herblain
Country [16] 0 0
France
State/province [16] 0 0
Villejuif
Country [17] 0 0
Italy
State/province [17] 0 0
Campania
Country [18] 0 0
Italy
State/province [18] 0 0
Emilia-Romagna
Country [19] 0 0
Italy
State/province [19] 0 0
Lazio
Country [20] 0 0
Italy
State/province [20] 0 0
Lombardia
Country [21] 0 0
Korea, Republic of
State/province [21] 0 0
Daegu
Country [22] 0 0
Korea, Republic of
State/province [22] 0 0
Seoul
Country [23] 0 0
Mexico
State/province [23] 0 0
Nuevo LEON
Country [24] 0 0
Panama
State/province [24] 0 0
Panama
Country [25] 0 0
Peru
State/province [25] 0 0
San Isidro
Country [26] 0 0
Poland
State/province [26] 0 0
Bialystok
Country [27] 0 0
Poland
State/province [27] 0 0
Gdynia
Country [28] 0 0
Poland
State/province [28] 0 0
Gliwice
Country [29] 0 0
Poland
State/province [29] 0 0
Poznan
Country [30] 0 0
Poland
State/province [30] 0 0
Warszawa
Country [31] 0 0
Russian Federation
State/province [31] 0 0
Moskovskaja Oblast
Country [32] 0 0
Russian Federation
State/province [32] 0 0
Sverdlovsk
Country [33] 0 0
Russian Federation
State/province [33] 0 0
Tatarstan
Country [34] 0 0
Russian Federation
State/province [34] 0 0
Murmansk
Country [35] 0 0
Russian Federation
State/province [35] 0 0
Tomsk
Country [36] 0 0
Russian Federation
State/province [36] 0 0
Volgograd
Country [37] 0 0
Spain
State/province [37] 0 0
LA Coruña
Country [38] 0 0
Spain
State/province [38] 0 0
Madrid
Country [39] 0 0
Taiwan
State/province [39] 0 0
Taichung
Country [40] 0 0
Taiwan
State/province [40] 0 0
Taipei City
Country [41] 0 0
Taiwan
State/province [41] 0 0
Taoyuan City
Country [42] 0 0
Thailand
State/province [42] 0 0
Bangkok
Country [43] 0 0
Thailand
State/province [43] 0 0
Muang
Country [44] 0 0
United Kingdom
State/province [44] 0 0
London
Country [45] 0 0
United Kingdom
State/province [45] 0 0
Manchester

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/NCT04300647