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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02684006
Registration number
NCT02684006
Ethics application status
Date submitted
25/01/2016
Date registered
17/02/2016
Titles & IDs
Public title
A Study of Avelumab With Axitinib Versus Sunitinib In Advanced Renal Cell Cancer (JAVELIN Renal 101)
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Scientific title
A PHASE 3, MULTINATIONAL, RANDOMIZED, OPEN-LABEL, PARALLEL-ARM STUDY OF AVELUMAB (MSB0010718C) IN COMBINATION WITH AXITINIB (INLYTA(REGISTERED)) VERSUS SUNITINIB (SUTENT(REGISTERED)) MONOTHERAPY IN THE FIRST-LINE TREATMENT OF PATIENTS WITH ADVANCED RENAL CELL CARCINOMA
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Secondary ID [1]
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2015-002429-20
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Secondary ID [2]
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B9991003
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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 Cancer
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Condition category
Condition code
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 - Avelumab (MSB0010718C)
Treatment: Drugs - Axitinib (AG-013736)
Treatment: Drugs - Sunitinib
Experimental: Avelumab in combination with axitinib - Avelumab administered at 10 mg/kg IV every two weeks in combination with axitinib, 5 mg PO BID.
Active comparator: Sunitinib - Sunitinib given at 50 mg PO QD on schedule 4/2
Treatment: Drugs: Avelumab (MSB0010718C)
IV treatment Avelumab administered at 10 mg/kg IV every two weeks
Treatment: Drugs: Axitinib (AG-013736)
Oral treatment Axitinib given 5 mg PO BID
Treatment: Drugs: Sunitinib
Oral treatment Sunitinib given at 50 mg PO QD on schedule 4/2
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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 (PFS) in PD-L1 positive patients
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Assessment method [1]
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Progression Free Survival (PFS) is the time from randomization to date of first documentation of objective progression of disease assessed by BICR (by RECIST version 1.1) or death due to any cause.
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Timepoint [1]
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From randomization up to 40 months.
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Primary outcome [2]
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Overall Survival in PD-L1 positive patients
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Assessment method [2]
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OS is the time from date of randomization to date of death due to any cause.
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Timepoint [2]
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Every 3 months up to 8 years
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Secondary outcome [1]
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Overall Survival (OS) in unselected patients
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Assessment method [1]
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OS is the time from date of randomization to date of death due to any cause.
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Timepoint [1]
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Every 3 months up to 8 years
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Secondary outcome [2]
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Number of participants with Objective Response (OR)
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Assessment method [2]
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Number of participants with objective response (ie, confirmed complete or partial response according to RECIST Version 1.1 recorded from randomization until disease progression assessed by BICR or death due to any cause)
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Timepoint [2]
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Every 6 weeks up to 18 months from patient enrollment in the study, then every 12 weeks up to 40 months from randomization
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Secondary outcome [3]
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Disease Control (DC)
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Assessment method [3]
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DC is defined as complete response (CR), partial response (PR), or stable disease (SD) according to the RECIST v.1.1 recorded from randomization until disease progression assessed by BICR or death due to any cause.
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Timepoint [3]
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Every 6 weeks up to 18 months from patient enrollment in the study, then every 12 weeks up to 40 months from randomization
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Secondary outcome [4]
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Time to Tumor Response (TTR)
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Assessment method [4]
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TRR is the time from randomization to first documentation of objective tumor response (CR or PR).
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Timepoint [4]
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Every 6 weeks up to 18 months from patient enrollment in the study, then every 12 weeks up to 40 months from randomization
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Secondary outcome [5]
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Duration of response (DR)
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Assessment method [5]
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DR is the time from the first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression assessed by BICR or death due to any cause
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Timepoint [5]
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Every 6 weeks up to 18 months from patient enrollment in the study, then every 12 weeks up to 40 months from randomization
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Secondary outcome [6]
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Progression Free Survival (PFS) by Investigator assessment
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Assessment method [6]
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Progression Free Survival (PFS) is the time from randomization to date of first documentation of objective progression of disease assessed by the Investigator (by RECIST version 1.1) or death due to any cause.
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Timepoint [6]
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Every 6 weeks up to 18 months from patient enrollment in the study, then every 12 weeks up to 40 months from randomization
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Secondary outcome [7]
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Trough plasma concentration (Ctrough) of avelumab
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Assessment method [7]
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Ctrough is defined as the concentration at the end of avelumab dosage interval
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Timepoint [7]
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Pre-dose
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Secondary outcome [8]
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Trough plasma concentration (Ctrough) of axitinib
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Assessment method [8]
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Ctrough is defined as the concentration at the end of axitinib dosage interval
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Timepoint [8]
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Pre-dose
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Secondary outcome [9]
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Maximum plasma concentration (Cmax) of axitinib
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Assessment method [9]
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Cmax defined as the maximum plasma concentration of axitinib
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Timepoint [9]
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2 hours post-dose
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Secondary outcome [10]
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Anti-Drug Antibody (ADA) levels of avelumab/Neutralizing antibodies titers for MSB0010718C
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Assessment method [10]
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Immunogenicity assessment of avelumab
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Timepoint [10]
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Pre-dose
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Secondary outcome [11]
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Tumor tissue biomarker status
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Assessment method [11]
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Biomarker status defined as positive or negative based on a pre-specified scoring algorithm involving, for example, PD-L1 expression and/or quantitation of tumor infiltrating CD8+T lymphocytes as assessed by IHC
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Timepoint [11]
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Baseline
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Secondary outcome [12]
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Overall Survival (OS) in biomarker-positive and biomarker-negative subgroups
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Assessment method [12]
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OS in biomarker-negative and biomarker-positive subgroups.
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Timepoint [12]
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Baseline
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Secondary outcome [13]
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Change From Baseline in FACT-Kidney Symptom Index (FKSI)-19
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Assessment method [13]
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The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains- Disease Related Symptoms (physical and emotional), Treatment related side effects and Functional and Well-Being . A negative change from Baseline represents a worsening of condition.
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Timepoint [13]
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Every 6 weeks up to 8 years
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Secondary outcome [14]
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Change from Baseline in European Quality of Life Questionnaire (EQ-5D) - Health State Profile
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Assessment method [14]
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EQ-5D Health State Profile: participant rated questionnaire to assess health-related quality of life in terms of a single index value.
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Timepoint [14]
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Every 6 weeks up to 8 years
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Secondary outcome [15]
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Progression Free Survival (PFS) in biomarker-positive and biomarker-negative subgroups
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Assessment method [15]
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PFS as measure of clinical outcome in biomarker-negative and biomarker-positive subgroups.
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Timepoint [15]
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Baseline
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Secondary outcome [16]
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Objective Response (OR) in biomarker-positive and biomarker-negative subgroups
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Assessment method [16]
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OR in biomarker-negative and biomarker-positive subgroups
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Timepoint [16]
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Baseline
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Secondary outcome [17]
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Disease Control (DC) in biomarker-positive and biomarker-negative subgroups
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Assessment method [17]
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DC in biomarker-negative and biomarker-positive subgroups
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Timepoint [17]
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Baseline
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Secondary outcome [18]
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Time To Response (TTR) in biomarker-positive and biomarker-negative subgroups
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Assessment method [18]
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TTR in biomarker-negative and biomarker-positive subgroups.
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Timepoint [18]
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Baseline
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Secondary outcome [19]
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Duration of Response (DR) in biomarker-positive and biomarker-negative subgroups
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Assessment method [19]
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DR in biomarker-negative and biomarker-positive subgroups.
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Timepoint [19]
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Baseline
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Secondary outcome [20]
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Change from Baseline in European Quality of Life Questionnaire (EQ-5D) - Visual Analogic Scale
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Assessment method [20]
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EQ-5D Visual Analogic Scale:patients rated their overall health status from 0 (worst imaginable heath state) to 100 (best imaginable heath state).
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Timepoint [20]
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Every 6 weeks up to 8 years
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Secondary outcome [21]
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Time to treatment discontinuation/failure due to toxicity (TTF)
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Assessment method [21]
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TTF is defined as the time from Cycle 1 Day 1 to the date of the first documentation of discontinuation due to an adverse event or death due to study treatment toxicity
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Timepoint [21]
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From Cycle 1 Day 1, every 6 weeks up to the End of Treatment
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Secondary outcome [22]
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Treatment discontinuation/failure due to toxicity
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Assessment method [22]
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Treatment discontinuation is the percentage of patients who discontinue the treatment due to an adverse event or death due to study treatment toxicity
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Timepoint [22]
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From Cycle 1 Day 1, every 6 weeks up to the End of Treatment
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Secondary outcome [23]
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PFS on next-line therapy (PFS2)
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Assessment method [23]
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PFS2 is defined as the time from randomization to discontinuation of next line treatment, second objective disease progression, or death from any cause, whichever occurs first.
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Timepoint [23]
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From randomization up to 8 years.
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Secondary outcome [24]
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Progression Free Survival (PFS) in unselected patients
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Assessment method [24]
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Progression Free Survival (PFS) is the time from randomization to date of first documentation of objective progression of disease assessed by BICR (by RECIST version 1.1) or death due to any cause.
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Timepoint [24]
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From randomization up to 40 months.
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Eligibility
Key inclusion criteria
* Histologically or cytologically confirmed advanced or metastatic RCC with clear cell component
* Availability of a formalin-fixed, paraffin-embedded (FFPE) tumor tissue block from a de novo tumor biopsy during screening (biopsied tumor lesion should not be a RECIST target lesion). Alternatively, a recently obtained archival FFPE tumor tissue block (not cut slides) from a primary or metastatic tumor resection or biopsy can be provided if the following criteria are met: 1) the biopsy or resection was performed within 1 year of randomization AND 2) the patient has not received any intervening systemic anti-cancer treatment from the time the tissue was obtained and randomization onto the current study. If an FFPE tissue block cannot be provided as per documented regulations then, 15 unstained slides (10 minimum) will be acceptable
* Availability of an archival FFPE tumor tissue from primary tumor resection specimen (if not provided per above). If an FFPE tissue block cannot be providedas per documented regulations 15 unstained slides (10 minimum) will be acceptable
* At least one measureable lesion as defined by RECIST version 1.1 that has not been previously irradiated
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Adequate bone marrow function, renal and liver functions
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Minimum age
18
Years
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Maximum age
No limit
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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
* Prior systemic therapy directed at advanced or metastatic RCC
* Prior adjuvant or neoadjuvant therapy for RCC if disease progression or relapse has occurred during or within 12 months after the last dose of treatment.
* Prior immunotherapy with IL-2, IFN-a, or anti PD 1, anti PD L1, anti PD L2, anti CD137, or anti cytotoxic T lymphocyte associated antigen 4 (CTLA 4) antibody (including ipilimumab), or any other antibody or drug specifically targeting T cell co stimulation or immune checkpoint pathways
* Prior therapy with axitinib and/or sunitinib as well as any prior therapies with other VEGF pathway inhibitors
* Newly dignosed or active brain metastasis
* Known severe hypersensitivity reactions to monoclonal antibodies (Grade =3), any history of anaphylaxis, or uncontrolled asthma (ie, 3 or more features of partially controlled asthma Global Initiative for Asthma 2011)
* Any of the following in the previous 12 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, LVEF less than LLN, clinically significant pericardial effusion, cerebrovascular accident, transient ischemic attack
* Any of the following in the previous 6 months: deep vein thrombosis or symptomatic pulmonary embolism
* Vaccination within 4 weeks of the first dose of avelumab and while on trial is prohibited except for administration of inactivated vaccines (for example, inactivated influenza vaccines)
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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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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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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
23/03/2016
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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
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Actual
26/06/2024
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Sample size
Target
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Accrual to date
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Final
886
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
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Macquarie University Hospital Pharmacy - Macquarie University
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Recruitment hospital [2]
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Macquarie University - Macquarie University
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Recruitment hospital [3]
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Nuclear Medicine Department - Randwick
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Recruitment hospital [4]
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Pharmacy Department, Clinical Trials - Randwick
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Recruitment hospital [5]
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Prince of Wales Hospital - Randwick
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Recruitment hospital [6]
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Spectrum Medical Imaging - Randwick
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Recruitment hospital [7]
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Division of Cancer Services - Woolloongabba
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Recruitment hospital [8]
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BHS Diagnostic Services - Ballarat
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Recruitment hospital [9]
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Lake Imaging - Ballarat
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Recruitment hospital [10]
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Box Hill Hospital - Box Hill
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Recruitment hospital [11]
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Eastern Health - Box Hill
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Recruitment hospital [12]
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Monash Health Translational Precinct, Monash Medical Centre - Clayton
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Recruitment hospital [13]
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Monash Medical Centre - Clayton
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Recruitment hospital [14]
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Monash Cancer Centre - East Bentleigh
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Recruitment hospital [15]
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Moorabbin Radiology - East Bentleigh
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Recruitment hospital [16]
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Slade Health - Mount Waverley
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Recruitment hospital [17]
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Ballarat Day Procedure Centre - Wendouree
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Recruitment hospital [18]
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Ballarat Oncology & Haematology Services - Wendouree
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Recruitment hospital [19]
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Nova Pharmacy - Wendouree
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Recruitment hospital [20]
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SKG Radiology - Murdoch
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Recruitment hospital [21]
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Fiona Stanley Hospital - Murdoch
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Recruitment hospital [22]
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St John of God Murdoch Hospital - Murdoch
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Recruitment hospital [23]
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EPIC Pharmacy Murdoch - Perth
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Recruitment postcode(s) [1]
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2109 - Macquarie University
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Recruitment postcode(s) [2]
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2031 - Randwick
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Recruitment postcode(s) [3]
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4102 - Woolloongabba
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Recruitment postcode(s) [4]
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3350 - Ballarat
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Recruitment postcode(s) [5]
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3128 - Box Hill
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Recruitment postcode(s) [6]
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3168 - Clayton
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Recruitment postcode(s) [7]
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3165 - East Bentleigh
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Recruitment postcode(s) [8]
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3149 - Mount Waverley
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Recruitment postcode(s) [9]
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3355 - Wendouree
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Recruitment postcode(s) [10]
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6050 - Murdoch
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Recruitment postcode(s) [11]
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6150 - Murdoch
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Recruitment postcode(s) [12]
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6150 - Perth
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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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Alabama
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United States of America
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California
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United States of America
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Colorado
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United States of America
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District of Columbia
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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State/province [7]
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Louisiana
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United States of America
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State/province [8]
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Maine
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United States of America
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State/province [9]
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Maryland
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0
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United States of America
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Massachusetts
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Country [11]
0
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United States of America
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Minnesota
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United States of America
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Missouri
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United States of America
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Montana
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United States of America
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Nevada
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United States of America
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New York
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United States of America
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North Carolina
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Ohio
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Pennsylvania
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Tennessee
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Texas
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United States of America
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Washington
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Austria
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Wien
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Belgium
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Brussels
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Belgium
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Bruxelles
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Belgium
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Gent
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Belgium
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Kortrijk
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Belgium
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Liège
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Ontario
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Canada
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Quebec
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Denmark
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Herlev
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Denmark
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Odense C
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France
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Cedex
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France
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CAEN cedex 05
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France
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Caen, Cedex 05
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France
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Le Mans
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France
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Lyon cedex 8
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France
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State/province [39]
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LYON cedex 8
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France
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State/province [40]
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Marseille
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France
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Rennes cedex
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France
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Saint-Herblain Cedex
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France
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Vandoeuvre les Nancy
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France
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Villejuif
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Germany
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Baden-wuerttemberg
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Germany
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Thuringia
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Hungary
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Budapest
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Country [48]
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Israel
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State/province [48]
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Ramat - GAN
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0
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Israel
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Beer Yaakov
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0
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Israel
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Haifa
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0
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Israel
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Kfar Saba
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0
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Israel
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Petach Tikva
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0
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Israel
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Ramat - Gan
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0
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Israel
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Tel Aviv
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0
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Italy
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(pn)
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Italy
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State/province [56]
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Milan
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Funding & Sponsors
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Name
Pfizer
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Summary
Brief summary
This is a phase 3 randomized trial evaluating the anti-tumor activity and safety of avelumab in combination with axitinib and of sunitinib monotherapy, administered as first-line treatment, in patients with advanced renal cell carcinoma
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Trial website
https://clinicaltrials.gov/study/NCT02684006
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Trial related presentations / publications
Rini BI, Moslehi JJ, Bonaca M, Schmidinger M, Albiges L, Choueiri TK, Motzer RJ, Atkins MB, Haanen J, Mariani M, Wang J, Hariharan S, Larkin J. Prospective Cardiovascular Surveillance of Immune Checkpoint Inhibitor-Based Combination Therapy in Patients With Advanced Renal Cell Cancer: Data From the Phase III JAVELIN Renal 101 Trial. J Clin Oncol. 2022 Jun 10;40(17):1929-1938. doi: 10.1200/JCO.21.01806. Epub 2022 Mar 3. Masters JC, Khandelwal A, di Pietro A, Dai H, Brar S. Model-informed drug development supporting the approval of the avelumab flat-dose regimen in patients with advanced renal cell carcinoma. CPT Pharmacometrics Syst Pharmacol. 2022 Apr;11(4):458-468. doi: 10.1002/psp4.12771. Epub 2022 Feb 27. Rini BI, Atkins MB, Choueiri TK, Thomaidou D, Rosbrook B, Thakur M, Hutson TE. Time to Resolution of Axitinib-Related Adverse Events After Treatment Interruption in Patients With Advanced Renal Cell Carcinoma. Clin Genitourin Cancer. 2021 Oct;19(5):e306-e312. doi: 10.1016/j.clgc.2021.03.019. Epub 2021 Apr 5. Choueiri TK, Larkin J, Pal S, Motzer RJ, Rini BI, Venugopal B, Alekseev B, Miyake H, Gravis G, Bilen MA, Hariharan S, Chudnovsky A, Ching KA, Mu XJ, Mariani M, Robbins PB, Huang B, di Pietro A, Albiges L. Efficacy and correlative analyses of avelumab plus axitinib versus sunitinib in sarcomatoid renal cell carcinoma: post hoc analysis of a randomized clinical trial. ESMO Open. 2021 Jun;6(3):100101. doi: 10.1016/j.esmoop.2021.100101. Epub 2021 Apr 23. Erratum In: ESMO Open. 2021 Aug;6(4):100177. doi: 10.1016/j.esmoop.2021.100177. Motzer RJ, Robbins PB, Powles T, Albiges L, Haanen JB, Larkin J, Mu XJ, Ching KA, Uemura M, Pal SK, Alekseev B, Gravis G, Campbell MT, Penkov K, Lee JL, Hariharan S, Wang X, Zhang W, Wang J, Chudnovsky A, di Pietro A, Donahue AC, Choueiri TK. Avelumab plus axitinib versus sunitinib in advanced renal cell carcinoma: biomarker analysis of the phase 3 JAVELIN Renal 101 trial. Nat Med. 2020 Nov;26(11):1733-1741. doi: 10.1038/s41591-020-1044-8. Epub 2020 Sep 7. Choueiri TK, Motzer RJ, Rini BI, Haanen J, Campbell MT, Venugopal B, Kollmannsberger C, Gravis-Mescam G, Uemura M, Lee JL, Grimm MO, Gurney H, Schmidinger M, Larkin J, Atkins MB, Pal SK, Wang J, Mariani M, Krishnaswami S, Cislo P, Chudnovsky A, Fowst C, Huang B, di Pietro A, Albiges L. Updated efficacy results from the JAVELIN Renal 101 trial: first-line avelumab plus axitinib versus sunitinib in patients with advanced renal cell carcinoma. Ann Oncol. 2020 Aug;31(8):1030-1039. doi: 10.1016/j.annonc.2020.04.010. Epub 2020 Apr 25. Motzer RJ, Penkov K, Haanen J, Rini B, Albiges L, Campbell MT, Venugopal B, Kollmannsberger C, Negrier S, Uemura M, Lee JL, Vasiliev A, Miller WH Jr, Gurney H, Schmidinger M, Larkin J, Atkins MB, Bedke J, Alekseev B, Wang J, Mariani M, Robbins PB, Chudnovsky A, Fowst C, Hariharan S, Huang B, di Pietro A, Choueiri TK. Avelumab plus Axitinib versus Sunitinib for Advanced Renal-Cell Carcinoma. N Engl J Med. 2019 Mar 21;380(12):1103-1115. doi: 10.1056/NEJMoa1816047. Epub 2019 Feb 16.
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Public notes
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Contacts
Principal investigator
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Pfizer CT.gov Call Center
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Pfizer
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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?
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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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?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
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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/NCT02684006