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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 17 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 17 months)
Secondary outcome [3] 0 0
IRC-Assessed Disease Control Rate (DCR)
Timepoint [3] 0 0
From randomization up to approximately 17 months
Secondary outcome [4] 0 0
Investigator-Assessed Best Clinical Response (BCR) Rate
Timepoint [4] 0 0
From randomization up to approximately 17 months
Secondary outcome [5] 0 0
Investigator-Assessed Duration of BCR
Timepoint [5] 0 0
First occurrence of a documented clinical response to the date of disease progression or death from any cause, whichever occurs first (up to approximately 17 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 17 months)
Secondary outcome [7] 0 0
IRC-Assessed PFS Rate at 6 Months
Timepoint [7] 0 0
6 months
Secondary outcome [8] 0 0
Overall Survival (OS)
Timepoint [8] 0 0
From randomization to death from any cause (up to approximately 17 months)
Secondary outcome [9] 0 0
OS Rate at 6 Months and 12 Months
Timepoint [9] 0 0
6 months, 12 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
28/02/2025
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
Bahia
Country [6] 0 0
Brazil
State/province [6] 0 0
Goiás
Country [7] 0 0
Brazil
State/province [7] 0 0
Rio Grande Do Sul
Country [8] 0 0
Brazil
State/province [8] 0 0
São Paulo
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 CEDEX
Country [17] 0 0
Italy
State/province [17] 0 0
Campania
Country [18] 0 0
Italy
State/province [18] 0 0
Lazio
Country [19] 0 0
Italy
State/province [19] 0 0
Lombardia
Country [20] 0 0
Korea, Republic of
State/province [20] 0 0
Daegu
Country [21] 0 0
Korea, Republic of
State/province [21] 0 0
Seoul
Country [22] 0 0
Mexico
State/province [22] 0 0
Nuevo LEON
Country [23] 0 0
Panama
State/province [23] 0 0
Panama
Country [24] 0 0
Peru
State/province [24] 0 0
San Isidro
Country [25] 0 0
Poland
State/province [25] 0 0
Gdynia
Country [26] 0 0
Poland
State/province [26] 0 0
Gliwice
Country [27] 0 0
Poland
State/province [27] 0 0
Poznan
Country [28] 0 0
Poland
State/province [28] 0 0
Warszawa
Country [29] 0 0
Russian Federation
State/province [29] 0 0
Sverdlovsk
Country [30] 0 0
Russian Federation
State/province [30] 0 0
Tatarstan
Country [31] 0 0
Russian Federation
State/province [31] 0 0
Tomsk
Country [32] 0 0
Russian Federation
State/province [32] 0 0
Volgograd
Country [33] 0 0
Spain
State/province [33] 0 0
La Coruna
Country [34] 0 0
Spain
State/province [34] 0 0
Madrid
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
Taoyuan City
Country [38] 0 0
Thailand
State/province [38] 0 0
Muang
Country [39] 0 0
United Kingdom
State/province [39] 0 0
London

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


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04300647