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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04987203
Registration number
NCT04987203
Ethics application status
Date submitted
23/07/2021
Date registered
3/08/2021
Date last updated
30/04/2024
Titles & IDs
Public title
Study to Compare Tivozanib in Combination With Nivolumab to Tivozanib Monotherapy in Subjects With Renal Cell Carcinoma
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Scientific title
TiNivo-2: A Phase 3, Randomized, Controlled, Multicenter, Open-label Study to Compare Tivozanib in Combination With Nivolumab to Tivozanib Monotherapy in Subjects With Renal Cell Carcinoma Who Have Progressed Following One or Two Lines of Therapy Where One Line Has an Immune Checkpoint Inhibitor
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Secondary ID [1]
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AV-951-20-304
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Renal Cell Carcinoma
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Condition category
Condition code
Cancer
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Non melanoma skin cancer
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Cancer
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Kidney
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Tivozanib
Treatment: Drugs - Nivolumab
Experimental: Tivozanib in Combination with Nivolumab - Subjects with advanced RCC will receive 0.89 mg of tivozanib once daily (QD) for 3 weeks followed by 1 week off study drug and nivolumab every 4 weeks on Day 1 of each Cycle, until disease progression or unacceptable toxicities occur, other withdrawal criteria are met, or completion of 2 years of treatment [for nivolumab] whichever occurs first.
Experimental: Tivozanib - Subjects with advanced RCC will receive 1.34 mg of tivozanib once daily (QD) for 3 weeks followed by 1 week off study drug until disease progression or unacceptable toxicities occur, or other withdrawal criteria are met.
Treatment: Drugs: Tivozanib
Tivozanib will be administered orally.
Treatment: Drugs: Nivolumab
Nivolumab will be administered via intravenous infusion.
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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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Progression free survival
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Assessment method [1]
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Comparison of the PFS of tivozanib in combination with nivolumab to tivozanib in subjects with RCC who have progressed following 1 or 2 lines of therapy. PFS is defined as the time from randomization to first documentation of objective tumor progression (progressive disease [PD], radiological) according to Response Evaluation Criteria In Solid Tumors (RECIST), or death due to any reasons whichever comes first.
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Timepoint [1]
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Until progressive disease [PD] (Approximately 30 months)
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Secondary outcome [1]
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Overall Survival
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Assessment method [1]
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Comparsion of the OS of subjects randomized to treatment with tivozanib in combination with nivolumab compared to tivozanib. OS is defined as the time from the date of randomization to date of death due to any cause.
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Timepoint [1]
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From Screening (Days -28 to -1) until death (Approximately 42 months)
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Secondary outcome [2]
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Progression free survival
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Assessment method [2]
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PFS is defined as the time from randomization to first documentation of objective tumor progression (progressive disease [PD], radiological) according to RECIST, or death due to any reasons whichever comes first. PFS as assessed by investigator.
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Timepoint [2]
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Until progressive disease [PD] (Approximately 30 months)
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Secondary outcome [3]
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Objective Response Rate
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Assessment method [3]
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Comparison of ORR of subjects randomized to treatment with tivozanib in combination with nivolumab compared to tivozanib. ORR is defined as the proportion of subjects with confirmed complete response or confirmed partial response according to RECIST relative to the total population of randomized subjects.
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Timepoint [3]
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From Screening (Days -28 to -1) until PD (Approximately 30 months)
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Secondary outcome [4]
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Duration of Response
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Assessment method [4]
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Comparison of DoR of subjects randomized to treatment with tivozanib in combination with nivolumab compared to tivozanib. DoR is defined as the time from the first documentation of objective tumor response to the first documentation of objective tumor progression or to death due to any cause.
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Timepoint [4]
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From Screening (Days -28 to -1) until PD or death (Approximately 30 months)
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Secondary outcome [5]
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Number of subjects with serious and non-serious adverse events
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Assessment method [5]
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Assessment of the safety and tolerability of tivozanib in combination with nivolumab compared to tivozanib.
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Timepoint [5]
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From Screening (Day -28 to Day -1) to Follow-up visit (30 days after last dose of study drug ± 7 days)
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Eligibility
Key inclusion criteria
- Radiographic disease progression during or following at least 6 weeks of treatment
with ICI for locally advanced or metastatic RCC with a clear cell component either in
first- or second-line treatment.
- Subjects must have recovered from the adverse events of prior therapy to grade = 1 or
baseline.
- Histologically or cytologically confirmed RCC with a clear cell component.
- Measurable disease per RECIST criteria Version 1.1.
- Eastern Cooperative Oncology Group performance status of 0 or 1.
- All participants must follow protocol defined contraceptive measures.
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Minimum age
18
Years
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Maximum age
130
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Subjects who received: a. A single agent tyrosine kinase inhibitor (TKI) in the first
line setting followed by a single agent immune checkpoint inhibitor (ICI) in the
second line setting; b. More than 2 prior lines of therapy in the advanced or
metastatic setting.
- History of life-threatening toxicity related to prior immune therapy.
- Active autoimmune disease as well as those that required discontinuation of prior
immuno-oncological (IO) therapy due to immune mediated AEs.
- Uncontrolled hypertension.
- More than 1 prior line of therapy with a checkpoint inhibitor in the metastatic
setting.
- Subjects on immune suppressive therapy for organ transplant or subjects with a history
of genetic or acquired immune suppression disease such as human immunodeficiency virus
(HIV) [Patients with HIV who have CD4+ T-cell counts >350 cells/µL, without a history
of acquired immune deficiency syndrome (AIDS)-defining opportunistic infections, and
are on established antiretroviral therapy which does not include a cytochrome P450
(CYP)3A4 inducer, for at least 4 weeks and have an HIV viral load less than 400
copies/mL, are eligible].
- History of clinically significant interstitial lung disease or current non-infectious
pneumonitis.
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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 3
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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
9/09/2021
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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
1/08/2025
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Actual
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Sample size
Target
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Accrual to date
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Final
343
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Liverpool Hospital Cancer Therapy Centre - Liverpool
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Mater Misericordiae Limited - Brisbane
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Princess Alexandra Hospital - Woolloongabba
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Sunshine Hospital - Geelong
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2170 - Liverpool
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4101 - Brisbane
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4102 - Woolloongabba
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3220 - Geelong
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Recruitment outside Australia
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Manchester
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Wolverhampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AVEO Pharmaceuticals, Inc.
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Parexel
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Bristol-Myers Squibb
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Ethics approval
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Summary
Brief summary
This study will be comparing tivozanib in combination with nivolumab to tivozanib alone in
subjects with advanced Renal Cell Carcinoma (RCC) who have had 1 or 2 prior lines of therapy,
one of which was an Immune Checkpoint Inhibitor (ICI).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04987203
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Contacts
Principal investigator
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04987203
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