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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
Date last updated
29/10/2024

Titles & IDs
Public title
A Study of Avelumab With Axitinib Versus Sunitinib In Advanced Renal Cell Cancer (JAVELIN Renal 101)
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
Secondary ID [1] 0 0
2015-002429-20
Secondary ID [2] 0 0
B9991003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Renal Cell Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Kidney

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) in Programmed Death-Ligand 1 (PD-L1) Positive Participants
Timepoint [1] 0 0
From date of randomization to the first documentation of PD or death due to any cause or censoring date, whichever occurred first (maximum up to approximately 26 months)
Primary outcome [2] 0 0
Overall Survival (OS) in PD-L1 Positive Participants
Timepoint [2] 0 0
From the date of randomization to the date of death due to any cause or censoring date, whichever occurred first (maximum up to approximately 89 months)
Secondary outcome [1] 0 0
PFS as Assessed by BICR in Participants Irrespective of PD-L1 Expression
Timepoint [1] 0 0
From date of randomization to the first documentation of PD or death due to any cause or censoring date, whichever occurred first (maximum up to approximately 26 months)
Secondary outcome [2] 0 0
OS in Participants Irrespective of PD-L1 Expression
Timepoint [2] 0 0
From the date of randomization to the date of death due to any cause or censoring date, whichever occurred first (maximum up to approximately 89 months)
Secondary outcome [3] 0 0
Percentage of Participants With Objective Response (OR) as Assessed by BICR Irrespective of PD-L1 Expression
Timepoint [3] 0 0
From date of randomization until PD (maximum up to approximately 26 months)
Secondary outcome [4] 0 0
Percentage of Participants With OR as Assessed by Investigator Irrespective of PD-L1 Expression
Timepoint [4] 0 0
From date of randomization until PD (maximum up to approximately 89 months)
Secondary outcome [5] 0 0
Percentage of Participants With Disease Control (DC) as Assessed by BICR Irrespective of PD-L1 Expression
Timepoint [5] 0 0
From date of randomization until PD (maximum up to approximately 26 months)
Secondary outcome [6] 0 0
Percentage of Participants With DC as Assessed by Investigator Irrespective of PD-L1 Expression
Timepoint [6] 0 0
From date of randomization until PD (maximum up to approximately 89 months)
Secondary outcome [7] 0 0
Time to Tumor Response (TTR) as Assessed by BICR in Participants Irrespective of PD-L1 Expression
Timepoint [7] 0 0
From the date of randomization to the first documentation of objective response (CR or PR) (maximum up to approximately 26 months)
Secondary outcome [8] 0 0
TTR as Assessed by Investigator in Participants Irrespective of PD-L1 Expression
Timepoint [8] 0 0
From the date of randomization to the first documentation of objective response (CR or PR) (maximum up to approximately 89 months)
Secondary outcome [9] 0 0
Duration of Response (DR) as Assessed by BICR in Participants Irrespective of PD-L1 Expression
Timepoint [9] 0 0
From documentation of OR until date of first documentation of PD or death due to any cause, whichever occurred first (maximum up to approximately 26 months)
Secondary outcome [10] 0 0
DR as Assessed by Investigator in Participants Irrespective of PD-L1 Expression
Timepoint [10] 0 0
From documentation of OR until date of first documentation of PD or death due to any cause, whichever occurred first (maximum up to approximately 89 months)
Secondary outcome [11] 0 0
PFS as Assessed by Investigator in Participants Irrespective of PD-L1 Expression
Timepoint [11] 0 0
From date of randomization until PD, whichever occurred first (maximum up to approximately 89 months)
Secondary outcome [12] 0 0
Progression-Free Survival on Next-line Therapy (PFS2) in Participants Irrespective of PD-L1 Expression
Timepoint [12] 0 0
From date of randomization until PD or death, whichever occurred first (maximum up to approximately 89 months)
Secondary outcome [13] 0 0
Number of Participants With Treatment-Emergent Adverse Events (AEs) Graded Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Version (V) 4.03
Timepoint [13] 0 0
From first dose of study drug to 90 days after last administration of study drug
Secondary outcome [14] 0 0
Number of Participants With Laboratory Abnormalities Based on NCI-CTCAE V4.03
Timepoint [14] 0 0
From first dose of study drug to 90 days after last administration of study drug
Secondary outcome [15] 0 0
Number of Participants With Vital Signs Abnormalities
Timepoint [15] 0 0
From first dose of study drug to 90 days after last administration of study drug
Secondary outcome [16] 0 0
Time to Treatment Discontinuation/Failure Due to Toxicity
Timepoint [16] 0 0
From first dose of study treatment until discontinuation of study treatment
Secondary outcome [17] 0 0
Number of Participants Who Discontinued Treatment Due to Toxicity
Timepoint [17] 0 0
From first dose of study treatment until discontinuation of study treatment
Secondary outcome [18] 0 0
Trough Plasma Concentration (Ctrough) of Avelumab
Timepoint [18] 0 0
Pre dose (0 hour) on Day 1, 15 and 29 of Cycle 1, Day 1 and 29 of Cycles 2, 3, 4 and Day 1 of Cycle 6
Secondary outcome [19] 0 0
Ctrough of Axitinib
Timepoint [19] 0 0
Pre dose (0 hour) on day 15 and 29 of cycle 1 (each cycle= 6 weeks)
Secondary outcome [20] 0 0
Maximum Plasma Concentration (Cmax) of Axitinib
Timepoint [20] 0 0
2 hours post-dose on Day 1, pre-dose and 2 hours post dose on Days 15 and 29 of Cycle 1
Secondary outcome [21] 0 0
Number of Participants With Positive PD-L1 Biomarker Expression in Pre-treatment Tumor Tissue
Timepoint [21] 0 0
At screening
Secondary outcome [22] 0 0
PFS in PD-L1 Biomarker-Positive and PD-L1 Biomarker-Negative Subgroups
Timepoint [22] 0 0
From date of randomization to the first documentation of PD or death due to any cause or censoring date, whichever occurred first (maximum up to approximately 26 months)
Secondary outcome [23] 0 0
Percentage of Participants With OR in PD-L1 Biomarker-Positive and PD-L1 Biomarker-Negative Subgroups
Timepoint [23] 0 0
From date of randomization until PD (maximum up to approximately 26 months)
Secondary outcome [24] 0 0
Percentage of Participants With DC in Biomarker-Positive Subgroup
Timepoint [24] 0 0
From date of randomization until PD or death, whichever occurred first (maximum up to approximately 26 months)
Secondary outcome [25] 0 0
TTR in Biomarker-Positive Subgroup
Timepoint [25] 0 0
From the date of randomization to the first documentation of objective response (CR or PR) (maximum up to approximately 26 months)
Secondary outcome [26] 0 0
DR in PD-L1 Biomarker-Positive and PD-L1 Biomarker-Negative Subgroups
Timepoint [26] 0 0
From documentation of OR until date of first documentation of PD or death due to any cause, whichever occurred first (maximum up to approximately 26 months)
Secondary outcome [27] 0 0
Number of Participants With Positive Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb) of Avelumab When Used in Combination With Axitinib
Timepoint [27] 0 0
From start of treatment until 30 days after the end of avelumab treatment (maximum up to approximately 89 months)
Secondary outcome [28] 0 0
Time to Symptom Deterioration (TTD) for Functional Assessment of Cancer Therapy (FACT)-Kidney Symptom Index - Disease Related Symptoms (FKSI-DRS)
Timepoint [28] 0 0
Date of randomization to the first time the participant's score showed a 3-point or greater decrease in FKSI-DRS (maximum up to approximately 26 months)
Secondary outcome [29] 0 0
Change From Baseline in European Quality of Life (EuroQol) 5-Dimension 5 Levels (EQ-5D-5L) Utility Score
Timepoint [29] 0 0
Baseline, Day 1 of Cycle 2 to Cycle 60, End of treatment (any Day from Day 1 of dosing; maximum up to approximately 89 months)
Secondary outcome [30] 0 0
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Score
Timepoint [30] 0 0
Baseline, Day 1 of Cycle 2 to Cycle 60, End of treatment (any Day from Day 1 of dosing; maximum up to approximately 89 months)

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 provided as per documented regulations 15 unstained slides (10 minimum) will be acceptable
* At least one measurable 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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 diagnosed 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)

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 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/03/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
26/06/2024
Sample size
Target
Accrual to date
Final
886
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Macquarie University Hospital Pharmacy - Macquarie University
Recruitment hospital [2] 0 0
Macquarie University - Macquarie University
Recruitment hospital [3] 0 0
Nuclear Medicine Department - Randwick
Recruitment hospital [4] 0 0
Pharmacy Department, Clinical Trials - Randwick
Recruitment hospital [5] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [6] 0 0
Spectrum Medical Imaging - Randwick
Recruitment hospital [7] 0 0
Division of Cancer Services - Woolloongabba
Recruitment hospital [8] 0 0
BHS Diagnostic Services - Ballarat
Recruitment hospital [9] 0 0
Lake Imaging - Ballarat
Recruitment hospital [10] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [11] 0 0
Eastern Health - Box Hill
Recruitment hospital [12] 0 0
Monash Health Translational Precinct, Monash Medical Centre - Clayton
Recruitment hospital [13] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [14] 0 0
Monash Cancer Centre - East Bentleigh
Recruitment hospital [15] 0 0
Moorabbin Radiology - East Bentleigh
Recruitment hospital [16] 0 0
Slade Health - Mount Waverley
Recruitment hospital [17] 0 0
Ballarat Day Procedure Centre - Wendouree
Recruitment hospital [18] 0 0
Ballarat Oncology & Haematology Services - Wendouree
Recruitment hospital [19] 0 0
Nova Pharmacy - Wendouree
Recruitment hospital [20] 0 0
SKG Radiology - Murdoch
Recruitment hospital [21] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [22] 0 0
St John of God Murdoch Hospital - Murdoch
Recruitment hospital [23] 0 0
EPIC Pharmacy Murdoch - Perth
Recruitment postcode(s) [1] 0 0
2109 - Macquarie University
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 0 0
3350 - Ballarat
Recruitment postcode(s) [5] 0 0
3128 - Box Hill
Recruitment postcode(s) [6] 0 0
3168 - Clayton
Recruitment postcode(s) [7] 0 0
3165 - East Bentleigh
Recruitment postcode(s) [8] 0 0
3149 - Mount Waverley
Recruitment postcode(s) [9] 0 0
3355 - Wendouree
Recruitment postcode(s) [10] 0 0
6050 - Murdoch
Recruitment postcode(s) [11] 0 0
6150 - Murdoch
Recruitment postcode(s) [12] 0 0
6150 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
State/province [2] 0 0
California
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United States of America
State/province [3] 0 0
Colorado
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United States of America
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District of Columbia
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United States of America
State/province [5] 0 0
Florida
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State/province [6] 0 0
Georgia
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Louisiana
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Maine
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Maryland
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United States of America
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Massachusetts
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Minnesota
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Missouri
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Montana
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Nevada
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United States of America
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New York
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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
Country [27] 0 0
Belgium
State/province [27] 0 0
Liège
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Canada
State/province [28] 0 0
Alberta
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Canada
State/province [29] 0 0
British Columbia
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Canada
State/province [30] 0 0
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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LYON cedex 8
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France
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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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Israel
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Ramat - GAN
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Israel
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Beer Yaakov
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Israel
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Haifa
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Kfar Saba
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Israel
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Petach Tikva
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Israel
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Ramat - Gan
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Israel
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Tel Aviv
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Italy
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(pn)
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Italy
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Milan
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Italy
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Rome
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Japan
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Aichi
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Japan
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Aomori
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Hokkaidô
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Japan
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Iwate
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Japan
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Kanagawa
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Japan
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Osaka
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Japan
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Shizuoka
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Japan
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Tokyo
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Japan
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Akita
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Japan
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Chiba
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Japan
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Fukuoka
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Japan
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Niigata
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Japan
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Tokushima
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Japan
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Yamagata
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Gyeonggido
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Korea, Republic of
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Daegu
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Korea, Republic of
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Daejeon
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Korea, Republic of
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Seoul
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Mexico
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Ciudad DE Mexico
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Mexico
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Nuevo LEON
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Mexico
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Oaxaca
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Netherlands
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Noord-holland
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Netherlands
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Zuid-holland
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Netherlands
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Eindhoven
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Netherlands
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Haarlem
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Netherlands
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Hoofddorp
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Netherlands
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Maastricht
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Netherlands
State/province [86] 0 0
Veldhoven
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New Zealand
State/province [87] 0 0
Auckland
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New Zealand
State/province [88] 0 0
BAY OF Plenty
Country [89] 0 0
New Zealand
State/province [89] 0 0
Manawatu- Whanganui
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New Zealand
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Manawatu-wanganui
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New Zealand
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Tauranga
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New Zealand
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Wairarapa
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New Zealand
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Christchurch
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New Zealand
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Hamilton
Country [95] 0 0
New Zealand
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Palmerston North
Country [96] 0 0
Romania
State/province [96] 0 0
Cluj-Napoca
Country [97] 0 0
Romania
State/province [97] 0 0
Craiova
Country [98] 0 0
Romania
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Timisoara
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Russian Federation
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Kursk Region
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Russian Federation
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Pesochny
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Russian Federation
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Poselok Pesochniy
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Russian Federation
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Saint-petersburg
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Russian Federation
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Moscow
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Russian Federation
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Nizhniy Novgorod
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Russian Federation
State/province [105] 0 0
Saint Petersburg
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Russian Federation
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Yaroslavl
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Spain
State/province [107] 0 0
Navarra
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Spain
State/province [108] 0 0
Madrid
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Spain
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Sevilla
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Sweden
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Gothenburg
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United Kingdom
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Cambridgeshire
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United Kingdom
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Middlesex
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United Kingdom
State/province [113] 0 0
Surrey, London
Country [114] 0 0
United Kingdom
State/province [114] 0 0
Surrey
Country [115] 0 0
United Kingdom
State/province [115] 0 0
Cambridge
Country [116] 0 0
United Kingdom
State/province [116] 0 0
Glasgow
Country [117] 0 0
United Kingdom
State/province [117] 0 0
London
Country [118] 0 0
United Kingdom
State/province [118] 0 0
Manchester
Country [119] 0 0
United Kingdom
State/province [119] 0 0
Nottingham

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

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
Trial website
https://clinicaltrials.gov/study/NCT02684006
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.
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Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02684006