A Study of Cabozantinib (XL184) vs Everolimus in Subjects With Metastatic Renal Cell Carcinoma
METEOR
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
1 other identifier
interventional
658
25 countries
191
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2013
Longer than P75 for phase_3
191 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 21, 2013
CompletedFirst Posted
Study publicly available on registry
May 31, 2013
CompletedStudy Start
First participant enrolled
June 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 22, 2015
CompletedResults Posted
Study results publicly available
July 18, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 15, 2021
CompletedApril 27, 2021
April 1, 2021
2 years
May 21, 2013
April 21, 2017
April 1, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free Survival (PFS)
The primary analysis of PFS is the time from randomization to date of first documented tumor progression as determined by investigator (per RECIST 1.1 criteria) or death due to any cause, whichever occurred first. A Kaplan-Meier analysis was performed to estimate the median duration.
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 Outcomes (2)
Overall Survival (OS)
OS was measured from the time of randomization until 320 deaths, approximately 28 months
Objective Response Rate (ORR)
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)
Study Arms (2)
Cabozantinib (XL184)
EXPERIMENTALCabozantinib (XL184) 60 mg tablet once daily.
Everolimus (Afinitor)
ACTIVE COMPARATOREverolimus (Afinitor) 10 mg tablet once daily.
Interventions
Eligibility Criteria
You may qualify if:
- Documented histological or cytological diagnosis of renal cell cancer with a clear-cell component.
- Measurable disease as determined by the investigator.
- Must have received at least one VEGFR-targeting TKI (eg, sorafenib, sunitinib, axitinib, pazopanib or tivozanib).
- Recovery from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy.
- Adequate organ and marrow function.
- 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.
- Female subjects of childbearing potential must not be pregnant at screening.
You may not qualify if:
- Prior treatment with everolimus, or any other specific or selective TORC1/PI3K/AKT inhibitor (eg, temsirolimus), or cabozantinib.
- Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before randomization.
- Receipt of any type of anticancer antibody (including investigational antibody) within 4 weeks before randomization.
- 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.
- Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery and stable for at least 3 months before randomization.
- Concomitant anticoagulation at therapeutic doses with oral anticoagulants or platelet inhibitors.
- Chronic treatment with corticosteroids or other immunosuppressive agents.
- Serious illness other than cancer.
- 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.
- Pregnant or lactating females.
- Diagnosis of another malignancy within 2 years before randomization, except for superficial skin cancers, or localized, low grade tumors.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Exelixislead
Study Sites (205)
Unknown Facility
Birmingham, Alabama, United States
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Anchorage, Alaska, 99503, United States
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Gilbert, Arizona, 85234, United States
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Scottsdale, Arizona, 85259, United States
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Tucson, Arizona, 85724, United States
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Duarte, California, 91010, United States
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La Jolla, California, 92093, United States
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Los Angeles, California, 90048, United States
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Los Angeles, California, 90095, United States
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Vallejo, California, 94589, United States
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Aurora, Colorado, 80045, United States
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Denver, Colorado, 80218, United States
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New Haven, Connecticut, 06520, United States
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Washington D.C., District of Columbia, 20007, United States
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Boca Raton, Florida, 33486, United States
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Miami, Florida, 33136, United States
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Miami, Florida, 33176, United States
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Orlando, Florida, 06520, United States
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Tampa, Florida, 33612, United States
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Chicago, Illinois, 60611, United States
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Chicago, Illinois, 60612, United States
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Chicago, Illinois, 60637, United States
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Iowa City, Iowa, 52242, United States
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Westwood, Kansas, 66205, United States
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Baltimore, Maryland, 21201, United States
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Baltimore, Maryland, 21287, United States
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Boston, Massachusetts, 02215, United States
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Ann Arbor, Michigan, 48109, United States
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Detroit, Michigan, 48201, United States
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Detroit, Michigan, 48202, United States
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Rochester, Minnesota, 55905, United States
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St Louis, Missouri, 63110, United States
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Las Vegas, Nevada, 89148, United States
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Albany, New York, 12206, United States
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New York, New York, 10065, United States
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Durham, North Carolina, 22710, United States
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Cleveland, Ohio, 44106, United States
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Cleveland, Ohio, 44195, United States
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Columbus, Ohio, 43210, United States
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Portland, Oregon, 97213, United States
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Portland, Oregon, 97239, United States
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Philadelphia, Pennsylvania, 19111, United States
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Pittsburgh, Pennsylvania, 15232, United States
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Charleston, South Carolina, 29425, United States
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Knoxville, Tennessee, 37920, United States
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Memphis, Tennessee, 38120, United States
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Nashville, Tennessee, 37203, United States
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Nashville, Tennessee, 37232, United States
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Austin, Texas, 78731, United States
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Bedford, Texas, 76022, United States
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Dallas, Texas, 75246, United States
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Fort Worth, Texas, 76104, United States
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Houston, Texas, 77024, United States
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Houston, Texas, 77030, United States
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San Antonio, Texas, 78229, United States
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Salt Lake City, Utah, 84112, United States
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Seattle, Washington, 98109, United States
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Vancouver, Washington, 98684, United States
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Yakima, Washington, 98902, United States
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La Plata, Buenos Aires, B1900BAJ, Argentina
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Mar del Plata, B7600LTO, Argentina
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Concord, New South Wales, 2139, Australia
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Darlinghurst, New South Wales, 2010, Australia
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Kogarah, New South Wales, 2217, Australia
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Port Macquarie, New South Wales, Australia
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Randwick, New South Wales, 2031, Australia
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Wahroonga, New South Wales, 2076, Australia
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Westmead, New South Wales, 2145, Australia
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Milton, Queensland, 4064, Australia
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Wooloongabba, Queensland, 4102, Australia
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Adelaide, South Australia, 5000, Australia
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Hobart, Tasmania, 7000, Australia
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Bentleight East, Victoria, 3165, Australia
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Box Hill, Victoria, 3128, Australia
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Wodonga, Victoria, 3690, Australia
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Linz, Upper Austria, 4010, Austria
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Vienna, 1090, Austria
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Vienna, 1100, Austria
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Bonheiden, Antwerpen, 2820, Belgium
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Brasschaat, Antwerpen, 2930, Belgium
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Brussels, Brussels Capital, 1000, Belgium
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Leuven, Vlaams Brabant, 3000, Belgium
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Roeselare, West-Vlaanderen, 8800, Belgium
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Antwerp, 2020, Belgium
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Liège, 4000, Belgium
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Calgary, Alberta, T2N 4N2, Canada
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Edmonton, Alberta, T6G 1Z2, Canada
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Vancouver, British Columbia, V5Z 4E6, Canada
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Winnepeg, Manitoba, R3A 1R9, Canada
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Halifax, Nova Scotia, B3H 1V7, Canada
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Hamilton, Ontario, L8V 5C2, Canada
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Kingston, Ontario, K7L 5P9, Canada
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London, Ontario, N6A 4L6, Canada
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Oshawa, Ontario, L1G 2B9, Canada
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Ottawa, Ontario, K1H 8L6, Canada
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Toronto, Ontario, M4N 3M5, Canada
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Toronto, Ontario, M5G 2N2, Canada
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Montreal, Quebec, H2L 4M1, Canada
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Saskatoon, Saskatchewan, S7N 4H4, Canada
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Santiago, Chile
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Olomouc, Olomoucký kraj, 775 20, Czechia
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Brno, 656 91, Czechia
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Prague, 128 08, Czechia
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Herlev, Capital Region, DK-2730, Denmark
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Aarhus, Central Jutland, DK-8000, Denmark
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Odense, Region Syddanmark, DK-5000, Denmark
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Turku, Länsi-Suomen Lääni, FI-20520, Finland
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Helsinki, 290, Finland
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Caen, Calvados, 14076, France
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Besançon, Doubs, 25030, France
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Bordeaux, Gironde, 33075, France
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Toulouse, Haute-Garonne, 31052, France
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Rennes, Ille-et-Vilaine, 35042, France
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Nantes, Loire-Atlantique, 44805, France
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Lyon, Rhône, 96008, France
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Le Mans, Sarthe, 72000, France
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Villejuif, Val-de-Marne, 94805, France
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Marseille, 13273, France
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Paris, 75908, France
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Freiburg im Breisgau, Baden Wuttemberg, 79106, Germany
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Tübingen, Baden-Wurttemberg, 72076, Germany
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Ulm, Baden-Wurttemberg, 89075, Germany
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Erlangen, Bavaria, 91054, Germany
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Aachen, North Rhine-Westphalia, 52074, Germany
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Essen, North Rhine-Westphalia, 45122, Germany
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Mainz, Rhineland-Palatinate, 55131, Germany
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Erfurt, Thuringia, 99089, Germany
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Jena, Thuringia, 99089, Germany
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Berlin, 12200, Germany
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Dresden, 01307, Germany
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Frankfurt am Main, 60590, Germany
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Gütersloh, 33332, Germany
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Hamburg, 20246, Germany
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Hanover, 30605, Germany
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Heidelberg, 69120, Germany
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Munich, 81377, Germany
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München, 81675, Germany
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Budapest, 1122, Hungary
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Szolnok, 5004, Hungary
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Dublin, 24, Ireland
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Dublin, 7, Ireland
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Bari, Apulia, 70124, Italy
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Meldola, Emilia-Romagna, 47014, Italy
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Modena, Emilia-Romagna, 41124, Italy
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Ravenna, Emilia-Romagna, 48100, Italy
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Rome, Lazio, 00128, Italy
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Rome, Lazio, 00152, Italy
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Genoa, Liguria, 16132, Italy
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Cremona, Lombardy, Lombardia, Italy
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Arezzo, Tuscany, 52100, Italy
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Terni, Umbria, 05100, Italy
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Maastricht, Limburg, 6229 HX, Netherlands
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Amsterdam, North Holland, 1066 CX, Netherlands
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Leiden, South Holland, 2333 ZA, Netherlands
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Rotterdam, South Holland, 3045 PM, Netherlands
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Poznan, Greater Poland Voivodeship, 60-569, Poland
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Bialystok, Podlaskie Voivodeship, 15-027, Poland
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Gdansk, Pomeranian Voivodeship, 80-210, Poland
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Warsaw, 04-909, Poland
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Lisbon, 1500-650, Portugal
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Lisbon, 1649-035, Portugal
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Porto, 200-072, Portugal
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Moscow, 115478, Russia
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Omsk, 644013, Russia
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Saint Petersburg, 196247, Russia
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Yaroslavl, 150040, Russia
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Prešov, 08001, Slovakia
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Žilina, 01207, Slovakia
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Seoul, 110-744, South Korea
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Seoul, 120-752, South Korea
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Seoul, South Korea
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Badalona, Catalonia, 08003, Spain
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Barcelona, Catalonia, 08025, Spain
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L'Hospitalet de Llobregat, Catalonia, 08907, Spain
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Pamplona, Navarre, 31008, Spain
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Oviedo, Principality of Asturias, 33006, Spain
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Barcelona, 08035, Spain
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Madrid, 28034, Spain
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Madrid, 28041, Spain
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Madrid, 28922, Spain
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Málaga, Málaga, Spain
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Santiago de Compostela, 15706, Spain
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Seville, 28050, Spain
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Valencia, 46010, Spain
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Lund, Skåne County, SE-22185, Sweden
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Stockholm, Södermanland County, Sweden
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Umeå, Sweden
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Taichung, Taiwan
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Taipei, Taiwan
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Ankara, 6500, Turkey (Türkiye)
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Gaziantep, 27100, Turkey (Türkiye)
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Istanbul, 34365, Turkey (Türkiye)
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Izmir, 35100, Turkey (Türkiye)
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Birmingham, England, B15 2TH, United Kingdom
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Derby, England, DE22 3NE, United Kingdom
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Guildford, England, GU2 7XX, United Kingdom
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London, England, EC1A 7BE, United Kingdom
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London, England, SE1 9ER, United Kingdom
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London, England, United Kingdom
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Manchester, England, M20 4BX, United Kingdom
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Metropolitan Borough of Wirral, England, CH63 4JY, United Kingdom
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Northwood, England, HA6 2RN, United Kingdom
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Aberdeen, Scotland, AB25 2ZN, United Kingdom
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Edinburgh, Scotland, EH4 2XU, United Kingdom
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Glasgow, Scotland, United Kingdom
Related Publications (9)
Gong AJ, Ruchalski K, Kim HJ, Douek M, Gutierrez A, Patel M, Sai V, Coy H, Villegas B, Raman S, Goldin J. RECIST 1.1 Target Lesion Categorical Response in Metastatic Renal Cell Carcinoma: A Comparison of Conventional versus Volumetric Assessment. Radiol Imaging Cancer. 2023 Sep;5(5):e220166. doi: 10.1148/rycan.220166.
PMID: 37656041DERIVEDDenize 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.
PMID: 34921022DERIVEDPowles 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.
PMID: 34364385DERIVEDDonskov 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.
PMID: 31887537DERIVEDFlaifel 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.
PMID: 31371341DERIVEDCella 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.
PMID: 29377755DERIVEDEscudier 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.
PMID: 29309249DERIVEDChoueiri 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.
PMID: 27279544DERIVEDChoueiri 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.
PMID: 26406150DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Exelixis Medical Information
- Organization
- Exelixis, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2013
First Posted
May 31, 2013
Study Start
June 1, 2013
Primary Completion
May 22, 2015
Study Completion
January 15, 2021
Last Updated
April 27, 2021
Results First Posted
July 18, 2017
Record last verified: 2021-04