Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01865747




Registration number
NCT01865747
Ethics application status
Date submitted
21/05/2013
Date registered
31/05/2013
Date last updated
27/04/2021

Titles & IDs
Public title
A Study of Cabozantinib (XL184) vs Everolimus in Subjects With Metastatic Renal Cell Carcinoma
Scientific title
A Phase 3, Randomized, Controlled Study of Cabozantinib (XL184) vs Everolimus in Subjects With Metastatic Renal Cell Carcinoma That Has Progressed After Prior VEGFR Tyrosine Kinase Inhibitor Therapy
Secondary ID [1] 0 0
XL184-308
Universal Trial Number (UTN)
Trial acronym
METEOR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Renal Cell Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: Cabozantinib (XL184) - Cabozantinib (XL184) 60 mg tablet once daily.

Active comparator: Everolimus (Afinitor) - Everolimus (Afinitor) 10 mg tablet once daily.

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free Survival (PFS)
Timepoint [1] 0 0
PFS is measured from the date of randomization until the date of first documented disease progression or date of death from any cause as determined by the Independent Radiology Committee (IRC) per RECIST 1.1, assessed for up to 17 months.
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
OS was measured from the time of randomization until 320 deaths, approximately 28 months
Secondary outcome [2] 0 0
Objective Response Rate (ORR)
Timepoint [2] 0 0
ORR was assessed at 8 weeks post-randomization, every 8 weeks for 12 months, and every 12 weeks until date of disease progression or death, up to May 2015 (approximately 21 months)

Eligibility
Key inclusion criteria
Select

1. Documented histological or cytological diagnosis of renal cell cancer with a clear-cell component.
2. Measurable disease as determined by the investigator.
3. Must have received at least one VEGFR-targeting TKI (eg, sorafenib, sunitinib, axitinib, pazopanib or tivozanib).
4. Recovery from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy.
5. Adequate organ and marrow function.
6. Sexually active fertile subjects(male and female)must agree to use medically accepted methods of contraception during the course of the study and for 4 months after the last dose of study treatment.
7. Female subjects of childbearing potential must not be pregnant at screening.

Select
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Prior treatment with everolimus, or any other specific or selective TORC1/PI3K/AKT inhibitor (eg, temsirolimus), or cabozantinib.
2. Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before randomization.
3. Receipt of any type of anticancer antibody (including investigational antibody) within 4 weeks before randomization.
4. Radiation therapy for bone metastasis within 2 weeks, any other external radiation therapy within 4 weeks before randomization. Systemic treatment with radionuclides within 6 weeks before randomization. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible.
5. Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery and stable for at least 3 months before randomization.
6. Concomitant anticoagulation at therapeutic doses with oral anticoagulants or platelet inhibitors.
7. Chronic treatment with corticosteroids or other immunosuppressive agents.
8. Serious illness other than cancer.
9. Major surgery within 3 months before randomization. Complete wound healing from major surgery must have occurred 1 month before randomization and from minor surgery at least 10 days before randomization.
10. Pregnant or lactating females.
11. Diagnosis of another malignancy within 2 years before randomization, except for superficial skin cancers, or localized, low grade tumors.

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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC
Recruitment hospital [1] 0 0
- Concord
Recruitment hospital [2] 0 0
- Darlinghurst
Recruitment hospital [3] 0 0
- Kogarah
Recruitment hospital [4] 0 0
- Port Macquarie
Recruitment hospital [5] 0 0
- Randwick
Recruitment hospital [6] 0 0
- Wahroonga
Recruitment hospital [7] 0 0
- Westmead
Recruitment hospital [8] 0 0
- Milton
Recruitment hospital [9] 0 0
- Wooloongabba
Recruitment hospital [10] 0 0
- Adelaide
Recruitment hospital [11] 0 0
- Hobart
Recruitment hospital [12] 0 0
- Bentleight East
Recruitment hospital [13] 0 0
- Box Hill
Recruitment hospital [14] 0 0
- Wodonga
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
2217 - Kogarah
Recruitment postcode(s) [4] 0 0
- Port Macquarie
Recruitment postcode(s) [5] 0 0
2031 - Randwick
Recruitment postcode(s) [6] 0 0
2076 - Wahroonga
Recruitment postcode(s) [7] 0 0
2145 - Westmead
Recruitment postcode(s) [8] 0 0
4064 - Milton
Recruitment postcode(s) [9] 0 0
4102 - Wooloongabba
Recruitment postcode(s) [10] 0 0
5000 - Adelaide
Recruitment postcode(s) [11] 0 0
7000 - Hobart
Recruitment postcode(s) [12] 0 0
3165 - Bentleight East
Recruitment postcode(s) [13] 0 0
3128 - Box Hill
Recruitment postcode(s) [14] 0 0
3690 - Wodonga
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Alaska
Country [3] 0 0
United States of America
State/province [3] 0 0
Arizona
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Connecticut
Country [7] 0 0
United States of America
State/province [7] 0 0
District of Columbia
Country [8] 0 0
United States of America
State/province [8] 0 0
Florida
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Iowa
Country [11] 0 0
United States of America
State/province [11] 0 0
Kansas
Country [12] 0 0
United States of America
State/province [12] 0 0
Maryland
Country [13] 0 0
United States of America
State/province [13] 0 0
Massachusetts
Country [14] 0 0
United States of America
State/province [14] 0 0
Michigan
Country [15] 0 0
United States of America
State/province [15] 0 0
Minnesota
Country [16] 0 0
United States of America
State/province [16] 0 0
Missouri
Country [17] 0 0
United States of America
State/province [17] 0 0
Nevada
Country [18] 0 0
United States of America
State/province [18] 0 0
New York
Country [19] 0 0
United States of America
State/province [19] 0 0
North Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
Ohio
Country [21] 0 0
United States of America
State/province [21] 0 0
Oregon
Country [22] 0 0
United States of America
State/province [22] 0 0
Pennsylvania
Country [23] 0 0
United States of America
State/province [23] 0 0
South Carolina
Country [24] 0 0
United States of America
State/province [24] 0 0
Tennessee
Country [25] 0 0
United States of America
State/province [25] 0 0
Texas
Country [26] 0 0
United States of America
State/province [26] 0 0
Utah
Country [27] 0 0
United States of America
State/province [27] 0 0
Washington
Country [28] 0 0
Argentina
State/province [28] 0 0
Buenos Aires
Country [29] 0 0
Argentina
State/province [29] 0 0
Mar Del Plata
Country [30] 0 0
Austria
State/province [30] 0 0
Oberösterreich
Country [31] 0 0
Austria
State/province [31] 0 0
Wien
Country [32] 0 0
Belgium
State/province [32] 0 0
Antwerpen
Country [33] 0 0
Belgium
State/province [33] 0 0
Brussels
Country [34] 0 0
Belgium
State/province [34] 0 0
Vlaams Brabant
Country [35] 0 0
Belgium
State/province [35] 0 0
West-Vlaanderen
Country [36] 0 0
Belgium
State/province [36] 0 0
Liege
Country [37] 0 0
Canada
State/province [37] 0 0
Alberta
Country [38] 0 0
Canada
State/province [38] 0 0
British Columbia
Country [39] 0 0
Canada
State/province [39] 0 0
Manitoba
Country [40] 0 0
Canada
State/province [40] 0 0
Nova Scotia
Country [41] 0 0
Canada
State/province [41] 0 0
Ontario
Country [42] 0 0
Canada
State/province [42] 0 0
Quebec
Country [43] 0 0
Canada
State/province [43] 0 0
Saskatchewan
Country [44] 0 0
Chile
State/province [44] 0 0
Santiago
Country [45] 0 0
Czechia
State/province [45] 0 0
Olomoucký Kraj
Country [46] 0 0
Czechia
State/province [46] 0 0
Brno
Country [47] 0 0
Czechia
State/province [47] 0 0
Prague
Country [48] 0 0
Denmark
State/province [48] 0 0
Hovedstaden
Country [49] 0 0
Denmark
State/province [49] 0 0
Midtjylland
Country [50] 0 0
Denmark
State/province [50] 0 0
Syddanmark
Country [51] 0 0
Finland
State/province [51] 0 0
Länsi-Suomen Lääni
Country [52] 0 0
Finland
State/province [52] 0 0
Helsinki
Country [53] 0 0
France
State/province [53] 0 0
Calvados
Country [54] 0 0
France
State/province [54] 0 0
Doubs
Country [55] 0 0
France
State/province [55] 0 0
Gironde
Country [56] 0 0
France
State/province [56] 0 0
Haute-Garonne
Country [57] 0 0
France
State/province [57] 0 0
Ille-et-Vilaine
Country [58] 0 0
France
State/province [58] 0 0
Loire-Atlantique
Country [59] 0 0
France
State/province [59] 0 0
Rhône
Country [60] 0 0
France
State/province [60] 0 0
Sarthe
Country [61] 0 0
France
State/province [61] 0 0
Val-de-Marne
Country [62] 0 0
France
State/province [62] 0 0
Marseille
Country [63] 0 0
France
State/province [63] 0 0
Paris
Country [64] 0 0
Germany
State/province [64] 0 0
Baden Wuttemberg
Country [65] 0 0
Germany
State/province [65] 0 0
Baden-Württemberg
Country [66] 0 0
Germany
State/province [66] 0 0
Bayern
Country [67] 0 0
Germany
State/province [67] 0 0
Nordrhein-Westfalen
Country [68] 0 0
Germany
State/province [68] 0 0
Rheinland-Pfalz
Country [69] 0 0
Germany
State/province [69] 0 0
Thuringen
Country [70] 0 0
Germany
State/province [70] 0 0
Thüringen
Country [71] 0 0
Germany
State/province [71] 0 0
Berlin
Country [72] 0 0
Germany
State/province [72] 0 0
Dresden
Country [73] 0 0
Germany
State/province [73] 0 0
Frankfurt am Main
Country [74] 0 0
Germany
State/province [74] 0 0
Guetersloh
Country [75] 0 0
Germany
State/province [75] 0 0
Hamburg
Country [76] 0 0
Germany
State/province [76] 0 0
Hannover
Country [77] 0 0
Germany
State/province [77] 0 0
Heidelberg
Country [78] 0 0
Germany
State/province [78] 0 0
Munchen
Country [79] 0 0
Germany
State/province [79] 0 0
Munich
Country [80] 0 0
Hungary
State/province [80] 0 0
Budapest
Country [81] 0 0
Hungary
State/province [81] 0 0
Szolnok
Country [82] 0 0
Ireland
State/province [82] 0 0
Dublin
Country [83] 0 0
Italy
State/province [83] 0 0
Emilia-Romagna
Country [84] 0 0
Italy
State/province [84] 0 0
Lazio
Country [85] 0 0
Italy
State/province [85] 0 0
Liguria
Country [86] 0 0
Italy
State/province [86] 0 0
Lombardia
Country [87] 0 0
Italy
State/province [87] 0 0
Puglia
Country [88] 0 0
Italy
State/province [88] 0 0
Toscana
Country [89] 0 0
Italy
State/province [89] 0 0
Umbria
Country [90] 0 0
Korea, Republic of
State/province [90] 0 0
Seoul
Country [91] 0 0
Netherlands
State/province [91] 0 0
Limburg
Country [92] 0 0
Netherlands
State/province [92] 0 0
Noord-Holland
Country [93] 0 0
Netherlands
State/province [93] 0 0
Zuid-Holland
Country [94] 0 0
Poland
State/province [94] 0 0
Podlaskie
Country [95] 0 0
Poland
State/province [95] 0 0
Pomorskie
Country [96] 0 0
Poland
State/province [96] 0 0
Wielkopolskie
Country [97] 0 0
Poland
State/province [97] 0 0
Warsaw
Country [98] 0 0
Portugal
State/province [98] 0 0
Lisbon
Country [99] 0 0
Portugal
State/province [99] 0 0
Porto
Country [100] 0 0
Russian Federation
State/province [100] 0 0
Moscow
Country [101] 0 0
Russian Federation
State/province [101] 0 0
Omsk
Country [102] 0 0
Russian Federation
State/province [102] 0 0
St. Petersburg
Country [103] 0 0
Russian Federation
State/province [103] 0 0
Yaroslavl
Country [104] 0 0
Slovakia
State/province [104] 0 0
Presov
Country [105] 0 0
Slovakia
State/province [105] 0 0
Zilina
Country [106] 0 0
Spain
State/province [106] 0 0
Asturias
Country [107] 0 0
Spain
State/province [107] 0 0
Cataluna
Country [108] 0 0
Spain
State/province [108] 0 0
Cataluña
Country [109] 0 0
Spain
State/province [109] 0 0
Navarra
Country [110] 0 0
Spain
State/province [110] 0 0
Barcelona
Country [111] 0 0
Spain
State/province [111] 0 0
Madrid
Country [112] 0 0
Spain
State/province [112] 0 0
Málaga
Country [113] 0 0
Spain
State/province [113] 0 0
Santiago de Compostela
Country [114] 0 0
Spain
State/province [114] 0 0
Seville
Country [115] 0 0
Spain
State/province [115] 0 0
Valencia
Country [116] 0 0
Sweden
State/province [116] 0 0
Skane Lan
Country [117] 0 0
Sweden
State/province [117] 0 0
Sodermanlands Lan
Country [118] 0 0
Sweden
State/province [118] 0 0
Umea
Country [119] 0 0
Taiwan
State/province [119] 0 0
Taichung
Country [120] 0 0
Taiwan
State/province [120] 0 0
Taipei
Country [121] 0 0
Turkey
State/province [121] 0 0
Ankara
Country [122] 0 0
Turkey
State/province [122] 0 0
Gaziantep
Country [123] 0 0
Turkey
State/province [123] 0 0
Istanbul
Country [124] 0 0
Turkey
State/province [124] 0 0
Izmir
Country [125] 0 0
United Kingdom
State/province [125] 0 0
England
Country [126] 0 0
United Kingdom
State/province [126] 0 0
Scotland

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

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the effect of Cabozantinib (XL184) compared with Everolimus (Afinitor) on progression-free survival (PFS) and overall survival (OS) in subjects with advanced renal cell cancer that has progressed after prior VEGFR tyrosine kinase inhibitor therapy.
Trial website
https://clinicaltrials.gov/study/NCT01865747
Trial related presentations / publications
Denize T, Farah S, Cimadamore A, Flaifel A, Walton E, Sticco-Ivins MA, Labaki C, Braun DA, Sun M, Wang E, Xie W, Choueiri TK, Signoretti S. Biomarkers of Angiogenesis and Clinical Outcomes to Cabozantinib and Everolimus in Patients with Metastatic Renal Cell Carcinoma from the Phase III METEOR Trial. Clin Cancer Res. 2022 Feb 15;28(4):748-755. doi: 10.1158/1078-0432.CCR-21-3088.
Powles T, Choueiri TK, Motzer RJ, Jonasch E, Pal S, Tannir NM, Signoretti S, Kaldate R, Scheffold C, Wang E, Aftab DT, Escudier B, George DJ. Outcomes based on plasma biomarkers in METEOR, a randomized phase 3 trial of cabozantinib vs everolimus in advanced renal cell carcinoma. BMC Cancer. 2021 Aug 7;21(1):904. doi: 10.1186/s12885-021-08630-w. Erratum In: BMC Cancer. 2021 Sep 15;21(1):1023. doi: 10.1186/s12885-021-08693-9.
Donskov F, Motzer RJ, Voog E, Hovey E, Grullich C, Nott LM, Cuff K, Gil T, Jensen NV, Chevreau C, Negrier S, Depenbusch R, Bergmann L, Cornelio I, Champsaur A, Escudier B, Pal S, Powles T, Choueiri TK. Outcomes based on age in the phase III METEOR trial of cabozantinib versus everolimus in patients with advanced renal cell carcinoma. Eur J Cancer. 2020 Feb;126:1-10. doi: 10.1016/j.ejca.2019.10.032. Epub 2019 Dec 27.
Flaifel A, Xie W, Braun DA, Ficial M, Bakouny Z, Nassar AH, Jennings RB, Escudier B, George DJ, Motzer RJ, Morris MJ, Powles T, Wang E, Huang Y, Freeman GJ, Choueiri TK, Signoretti S. PD-L1 Expression and Clinical Outcomes to Cabozantinib, Everolimus, and Sunitinib in Patients with Metastatic Renal Cell Carcinoma: Analysis of the Randomized Clinical Trials METEOR and CABOSUN. Clin Cancer Res. 2019 Oct 15;25(20):6080-6088. doi: 10.1158/1078-0432.CCR-19-1135. Epub 2019 Aug 1.
Cella D, Escudier B, Tannir NM, Powles T, Donskov F, Peltola K, Schmidinger M, Heng DYC, Mainwaring PN, Hammers HJ, Lee JL, Roth BJ, Marteau F, Williams P, Baer J, Mangeshkar M, Scheffold C, Hutson TE, Pal S, Motzer RJ, Choueiri TK. Quality of Life Outcomes for Cabozantinib Versus Everolimus in Patients With Metastatic Renal Cell Carcinoma: METEOR Phase III Randomized Trial. J Clin Oncol. 2018 Mar 10;36(8):757-764. doi: 10.1200/JCO.2017.75.2170. Epub 2018 Jan 29.
Escudier B, Powles T, Motzer RJ, Olencki T, Aren Frontera O, Oudard S, Rolland F, Tomczak P, Castellano D, Appleman LJ, Drabkin H, Vaena D, Milwee S, Youkstetter J, Lougheed JC, Bracarda S, Choueiri TK. Cabozantinib, a New Standard of Care for Patients With Advanced Renal Cell Carcinoma and Bone Metastases? Subgroup Analysis of the METEOR Trial. J Clin Oncol. 2018 Mar 10;36(8):765-772. doi: 10.1200/JCO.2017.74.7352. Epub 2018 Jan 8.
Choueiri TK, Escudier B, Powles T, Tannir NM, Mainwaring PN, Rini BI, Hammers HJ, Donskov F, Roth BJ, Peltola K, Lee JL, Heng DYC, Schmidinger M, Agarwal N, Sternberg CN, McDermott DF, Aftab DT, Hessel C, Scheffold C, Schwab G, Hutson TE, Pal S, Motzer RJ; METEOR investigators. Cabozantinib versus everolimus in advanced renal cell carcinoma (METEOR): final results from a randomised, open-label, phase 3 trial. Lancet Oncol. 2016 Jul;17(7):917-927. doi: 10.1016/S1470-2045(16)30107-3. Epub 2016 Jun 5.
Choueiri TK, Escudier B, Powles T, Mainwaring PN, Rini BI, Donskov F, Hammers H, Hutson TE, Lee JL, Peltola K, Roth BJ, Bjarnason GA, Geczi L, Keam B, Maroto P, Heng DY, Schmidinger M, Kantoff PW, Borgman-Hagey A, Hessel C, Scheffold C, Schwab GM, Tannir NM, Motzer RJ; METEOR Investigators. Cabozantinib versus Everolimus in Advanced Renal-Cell Carcinoma. N Engl J Med. 2015 Nov 5;373(19):1814-23. doi: 10.1056/NEJMoa1510016. Epub 2015 Sep 25.
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01865747