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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
Date last updated
7/02/2025
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
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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
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Secondary ID [1]
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2019-004895-21
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Secondary ID [2]
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WO42017
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Universal Trial Number (UTN)
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Trial acronym
SKYSCRAPER-04
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cervical Cancer
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Condition category
Condition code
Cancer
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Womb (Uterine or endometrial cancer)
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Cancer
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Cervical (cervix)
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Independent Review Committee (IRC)-Assessed Objective Response Rate (ORR)
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Assessment method [1]
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ORR is defined as the percentage of participants with a complete response (CR) or a partial response (PR) on two consecutive occasions \>/=4 weeks apart, as determined by the IRC according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. The study enrolled patients with measurable disease as determined by the investigator. Participants found to have non-measurable disease at baseline according to RECIST v1.1 (through IRC assessment or Protocol Deviations) were only considered responders if they achieved a CR.
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Timepoint [1]
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From randomization up to approximately 17 months
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Secondary outcome [1]
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Percentage of Participants With Adverse Events
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Assessment method [1]
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An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
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Timepoint [1]
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Up to 36 months
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Secondary outcome [2]
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IRC-Assessed Duration of Response (DOR)
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Assessment method [2]
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DOR is defined for participants who had an objective response as the time from the first occurrence of a documented objective response (CR or PR) to the date of progressive disease (PD) or death from any cause (whichever occurred first), as determined by the IRC according to RECIST v1.1. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters at prior timepoints (including baseline). The study enrolled patients with measurable disease as determined by the investigator. Participants found to have non-measurable disease at baseline according to RECIST v1.1 (through IRC assessment or Protocol Deviations) were only considered responders if they achieved a CR.
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Timepoint [2]
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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)
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Secondary outcome [3]
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IRC-Assessed Disease Control Rate (DCR)
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Assessment method [3]
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Disease control rate is defined as the percentage of participants with a CR, PR, or stable disease (SD), as determined by the IRC according to RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. SD: neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD. Participants were classified as SD only if SD was observed on two consecutive assessments \>/= 6 weeks apart. The study enrolled patients with measurable disease as determined by the investigator. Participants found to have non-measurable disease at baseline according to RECIST v1.1 (through IRC assessment or Protocol Deviations) were only considered responders if they achieved a CR.
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Timepoint [3]
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From randomization up to approximately 17 months
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Secondary outcome [4]
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Investigator-Assessed Best Clinical Response (BCR) Rate
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Assessment method [4]
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BCR is defined as the percentage of participants with a CR, PR, or SD, as determined by the investigator. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. SD: neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD. Participants were classified as SD only if SD was observed on two consecutive assessments \>/= 6 weeks apart.
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Timepoint [4]
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From randomization up to approximately 17 months
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Secondary outcome [5]
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Investigator-Assessed Duration of BCR
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Assessment method [5]
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Duration of BCR is defined for BCR responders as the time from the first occurrence of a documented response (CR, PR, or SD) to the date of PD or death from any cause (whichever occurred first), as clinically determined by the investigator according to RECIST v1.1. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. SD: neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD. Participants were classified as SD only if SD was observed on two consecutive assessments \>/= 6 weeks apart. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters at prior timepoints (including baseline).
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Timepoint [5]
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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)
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Secondary outcome [6]
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IRC-Assessed Progression-Free Survival (PFS)
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Assessment method [6]
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PFS is defined as the time from randomization to the first occurrence of PD or death from any cause (whichever occurred first), as determined by the IRC according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline).
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Timepoint [6]
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From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 17 months)
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Secondary outcome [7]
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IRC-Assessed PFS Rate at 6 Months
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Assessment method [7]
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PFS rate is defined as the percentage of participants that were event free, as determined by the IRC according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline).
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Timepoint [7]
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6 months
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Secondary outcome [8]
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Overall Survival (OS)
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Assessment method [8]
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OS is defined as the time of randomization to death from any cause.
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Timepoint [8]
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From randomization to death from any cause (up to approximately 17 months)
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Secondary outcome [9]
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OS Rate at 6 Months and 12 Months
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Assessment method [9]
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Reported here are the percentages of participants who were still alive at 6 months and 12 months.
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Timepoint [9]
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6 months, 12 months
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
30/06/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
28/02/2025
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Actual
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Sample size
Target
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Accrual to date
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Final
172
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Mater Misericordiae Limited - South Brisbane
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Recruitment postcode(s) [1]
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4101 - South Brisbane
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arizona
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Country [2]
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United States of America
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State/province [2]
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California
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Country [3]
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United States of America
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State/province [3]
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Georgia
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Country [4]
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0
United States of America
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State/province [4]
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Oregon
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Country [5]
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Brazil
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State/province [5]
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Bahia
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Country [6]
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Brazil
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State/province [6]
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Goiás
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Country [7]
0
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Brazil
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State/province [7]
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Rio Grande Do Sul
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Country [8]
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Brazil
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State/province [8]
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São Paulo
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Country [9]
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Canada
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State/province [9]
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Ontario
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Country [10]
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Canada
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State/province [10]
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Quebec
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Country [11]
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Costa Rica
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State/province [11]
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San José
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Country [12]
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France
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State/province [12]
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Lyon
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Country [13]
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France
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State/province [13]
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Marseille
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Country [14]
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France
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State/province [14]
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Montpellier
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Country [15]
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France
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State/province [15]
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Saint Herblain
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Country [16]
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France
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State/province [16]
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Villejuif CEDEX
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Country [17]
0
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Italy
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State/province [17]
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Campania
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Country [18]
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Italy
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State/province [18]
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Lazio
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Country [19]
0
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Italy
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State/province [19]
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Lombardia
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Country [20]
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Korea, Republic of
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State/province [20]
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Daegu
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Country [21]
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Korea, Republic of
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State/province [21]
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Seoul
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Country [22]
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Mexico
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State/province [22]
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Nuevo LEON
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Country [23]
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Panama
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State/province [23]
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Panama
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Country [24]
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Peru
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State/province [24]
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San Isidro
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Poland
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Gdynia
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Poland
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State/province [26]
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Gliwice
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Country [27]
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Poland
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State/province [27]
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Poznan
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Country [28]
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Poland
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State/province [28]
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Warszawa
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Country [29]
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Russian Federation
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State/province [29]
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Sverdlovsk
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Country [30]
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Russian Federation
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State/province [30]
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Tatarstan
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Country [31]
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Russian Federation
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State/province [31]
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Tomsk
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Country [32]
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Russian Federation
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State/province [32]
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Volgograd
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Country [33]
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Spain
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State/province [33]
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La Coruna
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Country [34]
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Spain
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State/province [34]
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Madrid
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Country [35]
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Taiwan
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State/province [35]
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Taichung
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Country [36]
0
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Taiwan
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State/province [36]
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Taipei City
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Country [37]
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Taiwan
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State/province [37]
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Taoyuan City
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Country [38]
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Thailand
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State/province [38]
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Muang
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Country [39]
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United Kingdom
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State/province [39]
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Hoffmann-La Roche
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to evaluate the efficacy and safety of tiragolumab in combination with atezolizumab and atezolizumab monotherapy in patients with programmed death-ligand 1 (PD-L1)-positive cervical cancer (metastatic and/or recurrent).
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Trial website
https://clinicaltrials.gov/study/NCT04300647
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Clinical Trials
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Address
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Hoffmann-La Roche
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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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).
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/47/NCT04300647/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/47/NCT04300647/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT04300647
Download to PDF