AzTrials
AzTrials

Advanced or Metastatic (Medically or Surgically Unresectable) Clear-cell Renal Cell CarcinomaPhase 3NCT01668784

Study of Nivolumab (BMS-936558) vs. Everolimus in Pre-Treated Advanced or Metastatic Clear-cell Renal Cell Carcinoma (CheckMate 025)

A Phase 3 study testing Nivolumab and Everolimus in people with Advanced or Metastatic (Medically or Surgically Unresectable) Clear-cell Renal Cell Carcinoma, run by Bristol-Myers Squibb at 168 sites in 24 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of the study is to compare the clinical benefit, as measured by duration of overall survival, of Nivolumab vs. Everolimus in subjects with advanced or metastatic clear-cell renal cell carcinoma who have received prior anti-angiogenic therapy Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Nivolumab and Everolimus
Could I receive a placebo?
No, everyone receives an active treatment
How many people
821 participants
Where
168 sitesin 24 countries
Study dates
9 Oct 2012to 19 Jul 2021
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men \& women ≥18 years of age
  • Histologic confirmation of renal cell carcinoma (RCC) with clear-cell component
  • Advanced/metastatic RCC
  • Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
  • Received 1 or 2 prior anti-angiogenic therapy regimens in advanced or metastatic setting
  • No more than 3 total prior systemic treatment regimens in the advanced or metastatic setting, and evidence of progression on or after last treatment regimen received and within 6 months of enrollment
  • Karnofsky Performance Score ≥70%

Who cannot join

  • Any Central Nervous System (CNS) metastases or history of CNS metastases
  • Prior therapy with an Mammalian target of rapamycin (mTOR) inhibitor
  • Any active known or suspected autoimmune disease
  • Uncontrolled adrenal insufficiency
  • Active chronic liver disease
  • Prior malignancy active within past 3 years, except for locally curable cancers
  • Other protocol-defined inclusion/exclusion criteria apply

Trial locations and contacts

168 sites in 24 countries.

168 sites in 24 countries

United States39 sites

  • University Of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109-5946

  • Winship Cancer Institute.

    Atlanta, Georgia, 30322

  • University Of Colorado

    Aurora, Colorado, 80045

  • Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins

    Baltimore, Maryland, 21231-1000

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Medical University Of South Carolina

    Charleston, South Carolina, 29425

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

  • Northwestern University

    Chicago, Illinois, 60611

  • The Ohio State University

    Columbus, Ohio, 43210

  • Ut Southwestern Medical Center

    Dallas, Texas, 75390-9133

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Local Institution - 0182

    Fayetteville, Arkansas, 72703

  • St Francis Hospital

    Greenville, South Carolina, 29601

  • Local Institution - 0139

    Houston, Texas, 77030-4009

  • Indiana University Simon Cancer Center

    Indianapolis, Indiana, 46202

  • University Of Iowa Hospitals And Clinics

    Iowa City, Iowa, 52242

  • UCSD Moores Cancer Center

    La Jolla, California, 92093-0698

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Local Institution - 0024

    Los Angeles, California, 90033

  • University Of Southern California

    Los Angeles, California, 90033

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048

  • Loyola University Chicago

    Maywood, Illinois, 60153

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37203

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232-6307

  • Memorial Sloan Kettering Nassau

    New York, New York, 10065

  • Weill Cornell Medical College

    New York, New York, 10065

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140

  • Local Institution - 0076

    Richmond, Virginia, 23229

  • CTRC at UTHSC San Antonio

    San Antonio, Texas, 78229

  • Ucsf Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94115

  • Local Institution - 0009

    Seattle, Washington, 98109

  • University Of Washington

    Seattle, Washington, 98109

  • Stanford Cancer Institute

    Stanford, California, 94305

  • H. Lee Moffitt Cancer Center & Research Institute

    Tampa, Florida, 33612-9497

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

  • Local Institution - 0027

    Washington D.C., District of Columbia, 20007

Other trials in United States

Japan21 sites

  • Local Institution

    Akita, Akita, 0108543

  • Local Institution

    Chiba, Chiba, 2608717

  • Local Institution - 0167

    Hamamatsu, Shizuoka, 4313192

  • Local Institution

    Higashiku, Fukuoka, 812-8582

  • Local Institution

    Kobe-city, Hyogo, 650-0017

  • Local Institution

    Kumamoto, 860-8556

  • Local Institution

    Kyoto, Kyoto, 602-8566

  • Local Institution

    Morioka, Iwate, 0208505

  • Local Institution

    Osaka-sayama-shi, Osaka, 5898511

  • Local Institution

    Sapporo, Hokkaido, 0608543

  • Local Institution

    Sapporo, Hokkaido, 0608648

  • Local Institution - 0169

    Suita, Osaka, 5650871

  • Local Institution

    Tokushima, Tokushima, 7708503

  • Local Institution

    Tokyo, 1138603

  • Local Institution

    Tokyo, 1138655

  • Local Institution

    Tokyo, 1358550

  • Local Institution

    Tokyo, 1608582

  • Local Institution

    Tokyo, 1628666

  • Local Institution

    Tokyo, 1738606

  • Local Institution

    Yamagata, Yamagata, 9909585

  • Local Institution

    Yokohama, Kanagawa, 2360004

Other trials in Japan

France17 sites

  • Local Institution - 0008

    Bordeaux, 33075

  • Local Institution

    Bordeaux, 33075

  • Local Institution - 0007

    Lyon, 69373

  • Local Institution

    Lyon, 69373

  • Local Institution - 0004

    Marseille, 13009

  • Local Institution

    Marseille, 13009

  • Local Institution - 0118

    Paris, 75908

  • Local Institution - 0003

    Poitiers, 86000

  • Local Institution

    Poitiers, 86000

  • Local Institution - 0005

    Saint-Herblain, 44805

  • Local Institution

    Saint-Herblain, 44805

  • Local Institution - 0012

    Toulouse, 31059

  • Local Institution

    Toulouse, 31059

  • Local Institution - 0006

    Vandœuvre-lès-Nancy, Lorraine, 54519

  • Local Institution

    Vandœuvre-lès-Nancy, 54511

  • Local Institution - 0002

    Villejuif, 94805

  • Local Institution

    Villejuif, 94805

Other trials in France

Canada9 sites

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • QEII Health Sciences Centre

    Halfax, Nova Scotia, B3H 2Y9

  • Centre D'Oncologie Dr-Leon-Richard

    Moncton, New Brunswick, E1C 8X3

  • Chum, Hopital Notre-Dame

    Montreal, Quebec, H2L 4M1

  • Local Institution - 0145

    Montreal, H3T 1E2

  • Local Institution - 0143

    Oshawa, Ontario, L1G 2B9

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • BC Cancer Agency - Vancouver Centre

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Italy9 sites

  • Local Institution

    Arezzo, 52100

  • Local Institution

    Meldola (fc), 47014

  • Local Institution - 0082

    Milan, 20133

  • Local Institution

    Rimini, 47900

  • Local Institution

    Roma, 00144

  • Local Institution

    Roma, 00152

  • Local Institution - 0102

    Rozzano, 20089

  • Local Institution

    Siena, 53100

  • Local Institution

    Terni, 05100

Other trials in Italy

Germany8 sites

  • Local Institution

    Aachen, 52074

  • Local Institution

    Dresden, 01307

  • Local Institution

    Erlangen, 91054

  • Local Institution

    Essen, 45122

  • Local Institution

    Hanover, 30625

  • Local Institution - 0126

    Heidelberg, 69120

  • Local Institution

    Munich, 81675

  • Local Institution

    Tübingen, 72076

Other trials in Germany

Argentina6 sites

  • COIBA

    Berazategui, Buenos Aires, 1880

  • Local Institution

    Buenos Aires, C1280AEB

  • Local Institution

    Buenos Aires, C1426ANZ

  • Local Institution

    Capital Federal, Buenos Aires, 1431

  • Instituto Oncologico De Cordoba

    Córdoba, X5006HBF

  • Centro Para La Atencion Integral Del Paciente Oncologico

    San Miguel de Tucumán, Tucumán Province, 4000

Other trials in Argentina

Poland6 sites

  • Local Institution

    Gdansk, 80-219

  • Local Institution

    Lodz, 93-513

  • Local Institution

    Poznan, 60-569

  • Local Institution

    Rybnik, 44-200

  • Local Institution

    Warsaw, 00-909

  • Local Institution

    Wroclaw, 50-556

Other trials in Poland

Spain6 sites

  • Local Institution

    Barcelona, 08035

  • Local Institution - 0064

    L'Hospitalet de Llobregat, 08907

  • Local Institution

    Madrid, 28007

  • Local Institution

    Madrid, 28040

  • Local Institution

    Madrid, 28041

  • Local Institution

    Pamplona, Navarre, 31008

Other trials in Spain

Australia5 sites

  • Local Institution

    Box Hill, Victoria, 3128

  • Local Institution

    Clayton, Victoria, 3168

  • Local Institution

    Melbourne, Victoria, 3000

  • Local Institution - 0095

    Westmead, New South Wales, 2145

  • Local Institution

    Woodville South, South Australia, 5011

Other trials in Australia

United Kingdom5 sites

  • Local Institution

    Cambridge, Cambridgeshire, CB2 0QQ

  • Local Institution

    London, Greater London, HA6 2RN

  • Local Institution

    London, Greater London, SW3 6JJ

  • Local Institution - 0048

    Swansea, Carmarthenshire, SA2 8QA

  • Local Institution

    Swansea, Carmarthenshire, SA2 8QA

Other trials in United Kingdom

Belgium4 sites

  • Local Institution

    Brussels, 1090

  • Local Institution

    Brussels, 1200

  • Local Institution

    Ghent, 9000

  • Local Institution

    Leuven, 3000

Other trials in Belgium

Israel4 sites

  • Local Institution

    Haifa, 31096

  • Local Institution - 0148

    Petah Tikva, 49100

  • Local Institution

    Ramat Gan, 52621

  • Local Institution

    Tel Aviv, 64239

Other trials in Israel

Romania4 sites

  • Local Institution

    Bucharest, 022328

  • Local Institution

    Craiova, 200385

  • Local Institution

    Iași, 700106

  • Local Institution

    Timișoara, 300167

Other trials in Romania

Austria3 sites

  • Local Institution

    Linz, 4020

  • Local Institution

    Vienna, 1090

  • Local Institution

    Vienna, 1130

Other trials in Austria

Brazil3 sites

  • Local Institution - 0125

    Ijuí, Rio Grande do Sul, 98700-000

  • Local Institution - 0124

    São Paulo, 01246-000

  • Local Institution

    São Paulo, 01321-001

Other trials in Brazil

Czechia3 sites

  • Local Institution

    Hradec Králové, 500 05

  • Local Institution

    Olomouc, 779 00

  • Local Institution

    Prague, 150 06

Other trials in Czechia

Denmark3 sites

  • Local Institution

    Aarhus N, 8200

  • Local Institution

    Herlev, 2730

  • Local Institution - 0137

    Odense, 5000

Other trials in Denmark

Ireland3 sites

  • Local Institution - 0087

    Dublin, 7

  • Local Institution

    Dublin, Dublin 7

  • Local Institution

    Tallaght, Dublin, DUBLIN 24

Other trials in Ireland

Russia3 sites

  • Local Institution

    Moscow, 115478

  • Local Institution

    Moscow, 121309

  • Local Institution

    Saint Petersburg, 198255

Other trials in Russia

Greece2 sites

  • Alexandra General Hospital Of Athens

    Athens, 12462

  • Euromedica General Clinic of Thessaloniki

    Thessaloniki, 54645

Other trials in Greece

Norway2 sites

  • Local Institution

    Bergen, 5021

  • Local Institution

    Lorenskog, 1478

Other trials in Norway

Sweden2 sites

  • Local Institution

    Gothenberg, 413 45

  • Local Institution

    Solna, 171 64

Other trials in Sweden

Finland1 site

  • Local Institution

    Helsinki, 00029

Other trials in Finland

About this study

Official title: A Randomized, Open-Label, Phase 3 Study of Nivolumab (BMS-936558) vs. Everolimus in Subjects With Advanced or Metastatic Clear-Cell Renal Cell Carcinoma Who Have Received Prior Anti-Angiogenic Therapy

The purpose of the study is to compare the clinical benefit, as measured by duration of overall survival, of Nivolumab vs. Everolimus in subjects with advanced or metastatic clear-cell renal cell carcinoma who have received prior anti-angiogenic therapy

Being tested
Nivolumab, Everolimus
Medical subject headings
Neoplasm Metastasis, Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01668784
Study groupRoleWhat they receive
Arm 1: NivolumabExperimentalNivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Receives: Biological: Nivolumab
Arm 2: EverolimusActive comparatorEverolimus 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Receives: Drug: Everolimus

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS) at Primary Endpoint

    Overall Survival (OS) was defined as the time from randomization to the date of death. Participants that had not died were censored at last known date alive. Median OS time was calculated using Kaplan-Meier Estimates. Interim analysis for the Primary Endpoint occurred after 398 deaths (70% of the total OS events needed for final analysis). At that time the data monitoring committee noted that the pre-specified boundary for OS (nominal significance level p < 0.0148) was crossed while no new safety signals that would affect continuation of the study were found. The study was stopped early by the Sponsor, Bristol-Myers Squibb (BMS) and the interim analysis became the final analysis. As a result, participants in the everolimus groups could be assessed for a crossover to nivolumab treatment if they met all inclusion criteria.

    Measured: Randomization until 398 deaths, up to May 2015 (approximately 30 months)

Secondary outcomes (9)

  1. Investigator-assessed Objective Response Rate (ORR)

    ORR is defined as Percentage of participants with a best response of complete response (CR) or partial response (PR) divided by number of randomized participants. CR=Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.; PR=At least a 30% decrease in the sum of diameters of target lesions, the baseline sum diameters used as reference. Tumor assessments began at 8 weeks following randomization and continued every 8 weeks for the first year, then every 12 weeks thereafter until disease progression or death. CIs used Clopper and Pearson.

    Measured: from randomization up to disease progression or death (approximately up to 105 Months)

  2. Investigator-assessed Duration of Objective Response

    Duration of objective response is defined as the time from study start date to response, CR or partial response, PR) to the date of the first documented tumor progression as determined by the investigator (per RECIST 1.1 criteria or clinical) or death due to any cause, whichever occurred first. For participants who neither progress nor die, the duration of objective response were censored at the same time they were censored for the primary definition. CR=Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.; PR=At least a 30% decrease in the sum of diameters of target lesions, the baseline sum diameters used as reference. Based on Kaplan-Meier Estimates.

    Measured: From randomization to date of disease progression or death or censoring if no progression or death occurred (approximately 105 months)

  3. Investigator-assessed Time to Objective Response

    Time to objective response is defined as the time from randomization to first response (complete response, CR or partial response, PR). CR=Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.; PR=At least a 30% decrease in the sum of diameters of target lesions, the baseline sum diameters used as reference.

    Measured: Randomization to date of first response (approximately 105 months)

  4. Investigator-assessed Time of Progression-free Survival (PFS)

    PFS=time from randomization to date of first documented tumor progression as determined by investigator (per RECIST 1.1 criteria or clinical) or death due to any cause, whichever occurred first. Participants who die without a reported prior progression and without subsequent anti-cancer therapy were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who did not have any on-study tumor assessments and did not die were censored on the date they were randomized. Participants who received any subsequent anti-cancer therapy without a prior reported progression were censored at the last evaluable tumor assessment prior to or on initiation date of the subsequent anti-cancer therapy. Progressive disease: >=20% increase in sum of target lesion diameters and sum must show absolute increase of >=5mm; smallest sum on study as reference. Based on Kaplan-Meier Estimates.

    Measured: from randomization up to disease progression or death (approximately up to 105 Months)

  5. Overall Survival (OS) by Programmed Death-Ligand 1 (PD-L1) Expression Level

    Quantifiable PD-L1 expression=percent of tumor cell membrane staining in a minimum of 100 evaluable tumor cells per Dako PD-L1 IHC assay. If the PD-L1 staining could not be quantified it was classified as: indeterminate=tumor cell membrane staining hampered for reasons attributed to biology of tumor biopsy specimen and not due to improper sample preparation or handling; not evaluable=tumor biopsy specimen was not optimally collected or prepared. Not evaluable determined from H\&E process before the tumor biopsy specimen was sent for evaluation or from H\&E process during PD-L1 evaluation; baseline PD-L1 expression=if more than one tumor biopsy specimen was available, the most recently collected specimen with a quantifiable result. If all specimens for a given participant are either indeterminate or not evaluable, then the PD-L1 expression was considered indeterminate as long as at least one specimen is indeterminate. Otherwise, PD-L1 expression was considered not evaluable.

    Measured: Randomization to date of death or date of last contact for patients without documentation of death, up to May 2015 (approximately 30 months)

  6. Number of Participants With Serious Adverse Events, Death, Discontinuation Due to Adverse Events

    Adverse event (AE) defined: any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Serious adverse event (SAE) defined: a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.

    Measured: Day of first dose to 30 days post study completion (approximately 106 months)

  7. Percentage of Participants With Disease-related Symptom Progression (DRSP)

    Disease-related symptom progression rate (DRSPR)=a decrease of two points in the Functional Assessment of Cancer Therapy-Kidney Symptom Index - Disease Related Symptoms (FKSI-DRS) questionnaire relative to the participant's baseline FKSI-DRS score with no later increase above this threshold observed during the course of the study. The 9 items of the FKSI-DRS were summarized into a symptom scale ranging in score from 0 to 36, with 0 being the worst possible score and 36 being the best possible score. A single measure reporting a decrease of at least 2 units was considered disease-related symptom progression only if it was the last one available for the participant. In order to consider a questionnaire received as valid, over 50% of the items were to be completed. Calculated by the Clopper-Pearson method for each treatment group.

    Measured: from randomization up to disease progression or death (approximately up to 105 Months)

  8. Number of Participants Meeting Marked Laboratory Abnormality Criteria in Specific Liver and Thyroid Tests

    Aspartate aminotransferase, AST. Alanine aminotransaminase, ALT. Total bilirubin, tBIL. Thyroid stimulating hormone, TSH. Upper limit of normal (ULN). Units per Liter (U/L). Results reported in International System of Units (SI).

    Measured: Day 1 to 30 days post study completion (approximately 106 months)

  9. Number of Participants With Abnormal Hematology and Serum Chemistry Laboratory Parameters by Worse CTC Grade - SI Units

    Common Terminology Criteria (CTC) version 4.0 in International System of Units (SI); Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. Hematology parameters=Hemoglobin (Gr 3: < 8.0 g/dL), Platelet Count (Gr 3: 25.0 -< 50.0*10^9 c/L; Gr 4: < 25.0*10^9 c/L), Leukocyte Count (Gr 3: 1.0 -< 2.0*10^3 c/µL; Gr4: < 1.0*10^3 c/µL), Absolute Lymphocyte Count (Gr 3: 0.2 -< 0.5*10^3 c/µL; Gr 4: < 0.2*10^3 c/µL), Absolute Neutrophil Count (Gr 3: 0.5 - < 1.0*10^3 c/µL; Gr 4: < 0.5*10^3 c/µL). Liver Function parameters=Alkaline Phosphatase (Gr 3: > 5.0 - 20.0 U/L * ULN; Gr 4: > 20.0 U/L * ULN), AST (Gr 3: > 5.0 - 20.0 U/L * ULN; Gr 4: > 20.0 U/L * ULN), ALT (Gr 3: > 5.0 - 20.0 U/L * ULN; Gr 4: > 20.0 U/L * ULN), tBIL (Gr 3: > 3.0 - 10.0 mg/dL * ULN; Gr 4: > 10.0 mg/dL * ULN). Renal parameter=Creatinine (Grade: Gr3: > 3.0 - 6.0 mg/dL *ULN; Gr4: > 6.0 mg/dL *ULN). Cells per microliter (c/µL). Cells per Liter (c/L). Grams per deciliter (g/dL). Milligrams per deciliter (mg/dL).

    Measured: Day 1 to 30 days post study completion (approximately 106 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2012 (estimated)
  2. Study start9 Oct 2012
  3. Primary completion6 May 2015
  4. Study completion19 Jul 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
821 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01668784
Sponsor's protocol ID
CA209-025
Other IDs
2011-005132-26
Status last verified
Jul 2022
First submitted
16 Aug 2012
Last updated
9 Aug 2022
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Expanded access
Available

Publications

  • Klijn SL, Fenwick E, Kroep S, Johannesen K, Malcolm B, Kurt M, Kiff C, Borrill J. What Did Time Tell Us? A Comparison and Retrospective Validation of Different Survival Extrapolation Methods for Immuno-Oncologic Therapy in Advanced or Metastatic Renal Cell Carcinoma. Pharmacoeconomics. 2021 Mar;39(3):345-356. doi: 10.1007/s40273-020-00989-1. Epub 2021 Jan 11.

    PubMed 33428174

  • Ambavane A, Yang S, Atkins MB, Rao S, Shah A, Regan MM, McDermott DF, Michaelson MD. Clinical and economic outcomes of treatment sequences for intermediate- to poor-risk advanced renal cell carcinoma. Immunotherapy. 2020 Jan;12(1):37-51. doi: 10.2217/imt-2019-0199. Epub 2020 Jan 29.

    PubMed 31992108

  • Shah R, Botteman M, Solem CT, Luo L, Doan J, Cella D, Motzer RJ. A Quality-adjusted Time Without Symptoms or Toxicity (Q-TWiST) Analysis of Nivolumab Versus Everolimus in Advanced Renal Cell Carcinoma (aRCC). Clin Genitourin Cancer. 2019 Oct;17(5):356-365.e1. doi: 10.1016/j.clgc.2019.05.010. Epub 2019 May 31.

    PubMed 31272883

  • Long GV, Tykodi SS, Schneider JG, Garbe C, Gravis G, Rashford M, Agrawal S, Grigoryeva E, Bello A, Roy A, Rollin L, Zhao X. Assessment of nivolumab exposure and clinical safety of 480 mg every 4 weeks flat-dosing schedule in patients with cancer. Ann Oncol. 2018 Nov 1;29(11):2208-2213. doi: 10.1093/annonc/mdy408.

    PubMed 30215677

  • Escudier B, Motzer RJ, Sharma P, Wagstaff J, Plimack ER, Hammers HJ, Donskov F, Gurney H, Sosman JA, Zalewski PG, Harmenberg U, McDermott DF, Choueiri TK, Richardet M, Tomita Y, Ravaud A, Doan J, Zhao H, Hardy H, George S. Treatment Beyond Progression in Patients with Advanced Renal Cell Carcinoma Treated with Nivolumab in CheckMate 025. Eur Urol. 2017 Sep;72(3):368-376. doi: 10.1016/j.eururo.2017.03.037. Epub 2017 Apr 12.

    PubMed 28410865

  • Escudier B, Sharma P, McDermott DF, George S, Hammers HJ, Srinivas S, Tykodi SS, Sosman JA, Procopio G, Plimack ER, Castellano D, Gurney H, Donskov F, Peltola K, Wagstaff J, Gauler TC, Ueda T, Zhao H, Waxman IM, Motzer RJ; CheckMate 025 investigators. CheckMate 025 Randomized Phase 3 Study: Outcomes by Key Baseline Factors and Prior Therapy for Nivolumab Versus Everolimus in Advanced Renal Cell Carcinoma. Eur Urol. 2017 Dec;72(6):962-971. doi: 10.1016/j.eururo.2017.02.010. Epub 2017 Mar 3.

    PubMed 28262413

  • Cella D, Grunwald V, Nathan P, Doan J, Dastani H, Taylor F, Bennett B, DeRosa M, Berry S, Broglio K, Berghorn E, Motzer RJ. Quality of life in patients with advanced renal cell carcinoma given nivolumab versus everolimus in CheckMate 025: a randomised, open-label, phase 3 trial. Lancet Oncol. 2016 Jul;17(7):994-1003. doi: 10.1016/S1470-2045(16)30125-5. Epub 2016 Jun 6.

    PubMed 27283863

  • Motzer RJ, Escudier B, McDermott DF, George S, Hammers HJ, Srinivas S, Tykodi SS, Sosman JA, Procopio G, Plimack ER, Castellano D, Choueiri TK, Gurney H, Donskov F, Bono P, Wagstaff J, Gauler TC, Ueda T, Tomita Y, Schutz FA, Kollmannsberger C, Larkin J, Ravaud A, Simon JS, Xu LA, Waxman IM, Sharma P; CheckMate 025 Investigators. Nivolumab versus Everolimus in Advanced Renal-Cell Carcinoma. N Engl J Med. 2015 Nov 5;373(19):1803-13. doi: 10.1056/NEJMoa1510665. Epub 2015 Sep 25.

    PubMed 26406148

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nivolumab and Everolimus in people with Advanced or Metastatic (Medically or Surgically Unresectable) Clear-cell Renal Cell Carcinoma, run by Bristol-Myers Squibb at 168 sites in 24 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 168 sites in United States, Japan, France, Canada, Italy and 19 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) at Primary Endpoint (time frame: Randomization until 398 deaths, up to May 2015 (approximately 30 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01668784, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2022.

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