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

Primary Purpose

Advanced or Metastatic (Medically or Surgically Unresectable) Clear-cell Renal Cell Carcinoma

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Nivolumab

Everolimus

About this trial

This is an interventional treatment trial for Advanced or Metastatic (Medically or Surgically Unresectable) Clear-cell Renal Cell Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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%

Exclusion Criteria:

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm 1: Nivolumab

Arm 2: Everolimus

Arm Description

Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends

Everolimus 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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.

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.

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.

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.

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).

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).

Full Information

NCT ID

NCT01668784

First Posted

August 16, 2012

Last Updated

July 15, 2022

Sponsor

Bristol-Myers Squibb

Collaborators

Ono Pharmaceutical Co. Ltd

1. Study Identification

Unique Protocol Identification Number

NCT01668784

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Completed

Study Start Date

October 9, 2012 (Actual)

Primary Completion Date

May 6, 2015 (Actual)

Study Completion Date

July 19, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bristol-Myers Squibb

Collaborators

Ono Pharmaceutical Co. Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Advanced or Metastatic (Medically or Surgically Unresectable) Clear-cell Renal Cell Carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

821 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1: Nivolumab

Arm Type

Experimental

Arm Description

Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends

Arm Title

Arm 2: Everolimus

Arm Type

Active Comparator

Arm Description

Everolimus 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends

Intervention Type

Biological

Intervention Name(s)

Nivolumab

Other Intervention Name(s)

BMS-936558

Intervention Type

Drug

Intervention Name(s)

Everolimus

Other Intervention Name(s)

Afinitor

Primary Outcome Measure Information:

Title

Overall Survival (OS) at Primary Endpoint

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

Investigator-assessed Objective Response Rate (ORR)

Description

Time Frame

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

Title

Investigator-assessed Duration of Objective Response

Description

Time Frame

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

Title

Investigator-assessed Time to Objective Response

Description

Time Frame

Randomization to date of first response (approximately 105 months)

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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% Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bristol-Myers Squibb

Organizational Affiliation

Bristol-Myers Squibb

Official's Role

Study Director

Facility Information:

Facility Name

Local Institution - 0182

City

Fayetteville

State/Province

Arkansas

ZIP/Postal Code

72703

Country

United States

Facility Name

UCSD Moores Cancer Center

City

La Jolla

State/Province

California

ZIP/Postal Code

92093-0698

Country

United States

Facility Name

Local Institution - 0024

City

Los Angeles

State/Province

California

ZIP/Postal Code

90033

Country

United States

Facility Name

University Of Southern California

City

Los Angeles

State/Province

California

ZIP/Postal Code

90033

Country

United States

Facility Name

Cedars Sinai Medical Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90048

Country

United States

Facility Name

Ucsf Helen Diller Family Comprehensive Cancer Center

City

San Francisco

State/Province

California

ZIP/Postal Code

94115

Country

United States

Facility Name

Stanford Cancer Institute

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

Facility Name

University Of Colorado

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

Georgetown University Medical Center

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20007

Country

United States

Facility Name

Local Institution - 0027

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20007

Country

United States

Facility Name

H. Lee Moffitt Cancer Center & Research Institute

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612-9497

Country

United States

Facility Name

Winship Cancer Institute.

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

Facility Name

Northwestern University

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Facility Name

Loyola University Chicago

City

Maywood

State/Province

Illinois

ZIP/Postal Code

60153

Country

United States

Facility Name

Indiana University Simon Cancer Center

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Facility Name

University Of Iowa Hospitals And Clinics

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52242

Country

United States

Facility Name

Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21231-1000

Country

United States

Facility Name

Beth Israel Deaconess Medical Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

University Of Michigan Comprehensive Cancer Center

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109-5946

Country

United States

Facility Name

Karmanos Cancer Institute

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48201

Country

United States

Facility Name

Dartmouth-Hitchcock Medical Center

City

Lebanon

State/Province

New Hampshire

ZIP/Postal Code

03756

Country

United States

Facility Name

Roswell Park Cancer Institute

City

Buffalo

State/Province

New York

ZIP/Postal Code

14263

Country

United States

Facility Name

Memorial Sloan Kettering Nassau

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Facility Name

Weill Cornell Medical College

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Facility Name

Levine Cancer Institute

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28204

Country

United States

Facility Name

Duke University Medical Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Facility Name

The Ohio State University

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

Facility Name

Fox Chase Cancer Center

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19111

Country

United States

Facility Name

Temple University Hospital

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19140

Country

United States

Facility Name

Medical University Of South Carolina

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

Facility Name

St Francis Hospital

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29601

Country

United States

Facility Name

Tennessee Oncology, PLLC

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

Vanderbilt University Medical Center

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232-6307

Country

United States

Facility Name

Ut Southwestern Medical Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390-9133

Country

United States

Facility Name

Local Institution - 0139

City

Houston

State/Province

Texas

ZIP/Postal Code

77030-4009

Country

United States

Facility Name

CTRC at UTHSC San Antonio

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Local Institution - 0076

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23229

Country

United States

Facility Name

Local Institution - 0009

City

Seattle

State/Province

Washington

ZIP/Postal Code

98109

Country

United States

Facility Name

University Of Washington

City

Seattle

State/Province

Washington

ZIP/Postal Code

98109

Country

United States

Facility Name

COIBA

City

Berazategui

State/Province

Buenos Aires

ZIP/Postal Code

1880

Country

Argentina

Facility Name

Local Institution

City

Capital Federal

State/Province

Buenos Aires

ZIP/Postal Code

1431

Country

Argentina

Facility Name

Centro Para La Atencion Integral Del Paciente Oncologico

City

San Miguel De Tucuman

State/Province

Tucuman

ZIP/Postal Code

4000

Country

Argentina

Facility Name

Local Institution

City

Buenos Aires

ZIP/Postal Code

C1280AEB

Country

Argentina

Facility Name

Local Institution

City

Buenos Aires

ZIP/Postal Code

C1426ANZ

Country

Argentina

Facility Name

Instituto Oncologico De Cordoba

City

Cordoba

ZIP/Postal Code

X5006HBF

Country

Argentina

Facility Name

Local Institution - 0095

City

Westmead

State/Province

New South Wales

ZIP/Postal Code

2145

Country

Australia

Facility Name

Local Institution

City

Woodville South

State/Province

South Australia

ZIP/Postal Code

5011

Country

Australia

Facility Name

Local Institution

City

Box Hill

State/Province

Victoria

ZIP/Postal Code

3128

Country

Australia

Facility Name

Local Institution

City

Clayton

State/Province

Victoria

ZIP/Postal Code

3168

Country

Australia

Facility Name

Local Institution

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3000

Country

Australia

Facility Name

Local Institution

City

Linz

ZIP/Postal Code

4020

Country

Austria

Facility Name

Local Institution

City

Wien

ZIP/Postal Code

1090

Country

Austria

Facility Name

Local Institution

City

Wien

ZIP/Postal Code

1130

Country

Austria

Facility Name

Local Institution

City

Brussels

ZIP/Postal Code

1090

Country

Belgium

Facility Name

Local Institution

City

Bruxelles

ZIP/Postal Code

1200

Country

Belgium

Facility Name

Local Institution

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Local Institution

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Local Institution - 0125

City

Ijui

State/Province

RIO Grande DO SUL

ZIP/Postal Code

98700-000

Country

Brazil

Facility Name

Local Institution - 0124

City

Sao Paulo

ZIP/Postal Code

01246-000

Country

Brazil

Facility Name

Local Institution

City

Sao Paulo

ZIP/Postal Code

01321-001

Country

Brazil

Facility Name

Tom Baker Cancer Centre

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 4N2

Country

Canada

Facility Name

Cross Cancer Institute

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 1Z2

Country

Canada

Facility Name

BC Cancer Agency - Vancouver Centre

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 4E6

Country

Canada

Facility Name

Centre D'Oncologie Dr-Leon-Richard

City

Moncton

State/Province

New Brunswick

ZIP/Postal Code

E1C 8X3

Country

Canada

Facility Name

QEII Health Sciences Centre

City

Halfax

State/Province

Nova Scotia

ZIP/Postal Code

B3H 2Y9

Country

Canada

Facility Name

Local Institution - 0143

City

Oshawa

State/Province

Ontario

ZIP/Postal Code

L1G 2B9

Country

Canada

Facility Name

Princess Margaret Hospital

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2M9

Country

Canada

Facility Name

Chum, Hopital Notre-Dame

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2L 4M1

Country

Canada

Facility Name

Local Institution - 0145

City

Montreal

ZIP/Postal Code

H3T 1E2

Country

Canada

Facility Name

Local Institution

City

Hradec Kralove

ZIP/Postal Code

500 05

Country

Czechia

Facility Name

Local Institution

City

Olomouc

ZIP/Postal Code

779 00

Country

Czechia

Facility Name

Local Institution

City

Prague 5

ZIP/Postal Code

150 06

Country

Czechia

Facility Name

Local Institution

City

Aarhus N

ZIP/Postal Code

8200

Country

Denmark

Facility Name

Local Institution

City

Herlev

ZIP/Postal Code

2730

Country

Denmark

Facility Name

Local Institution - 0137

City

Odense

ZIP/Postal Code

5000

Country

Denmark

Facility Name

Local Institution

City

Helsinki

ZIP/Postal Code

00029

Country

Finland

Facility Name

Local Institution - 0006

City

Vandoeuvre-lès-Nancy

State/Province

Lorraine

ZIP/Postal Code

54519

Country

France

Facility Name

Local Institution - 0008

City

Bordeaux

ZIP/Postal Code

33075

Country

France

Facility Name

Local Institution

City

Bordeaux

ZIP/Postal Code

33075

Country

France

Facility Name

Local Institution - 0007

City

Lyon Cedex

ZIP/Postal Code

69373

Country

France

Facility Name

Local Institution

City

Lyon Cedex

ZIP/Postal Code

69373

Country

France

Facility Name

Local Institution - 0004

City

Marseille Cedex 9

ZIP/Postal Code

13009

Country

France

Facility Name

Local Institution

City

Marseille Cedex 9

ZIP/Postal Code

13009

Country

France

Facility Name

Local Institution - 0118

City

Paris

ZIP/Postal Code

75908

Country

France

Facility Name

Local Institution - 0003

City

Poitiers

ZIP/Postal Code

86000

Country

France

Facility Name

Local Institution

City

Poitiers

ZIP/Postal Code

86000

Country

France

Facility Name

Local Institution - 0005

City

Saint Herblain Cedex

ZIP/Postal Code

44805

Country

France

Facility Name

Local Institution

City

Saint Herblain Cedex

ZIP/Postal Code

44805

Country

France

Facility Name

Local Institution - 0012

City

Toulouse Cedex 9

ZIP/Postal Code

31059

Country

France

Facility Name

Local Institution

City

Toulouse Cedex 9

ZIP/Postal Code

31059

Country

France

Facility Name

Local Institution

City

Vandoeuvre Les Nancy

ZIP/Postal Code

54511

Country

France

Facility Name

Local Institution - 0002

City

Villejuif Cedex

ZIP/Postal Code

94805

Country

France

Facility Name

Local Institution

City

Villejuif Cedex

ZIP/Postal Code

94805

Country

France

Facility Name

Local Institution

City

Aachen

ZIP/Postal Code

52074

Country

Germany

Facility Name

Local Institution

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

Local Institution

City

Erlangen

ZIP/Postal Code

91054

Country

Germany

Facility Name

Local Institution

City

Essen

ZIP/Postal Code

45122

Country

Germany

Facility Name

Local Institution

City

Hannover

ZIP/Postal Code

30625

Country

Germany

Facility Name

Local Institution - 0126

City

Heidelberg

ZIP/Postal Code

69120

Country

Germany

Facility Name

Local Institution

City

Munich

ZIP/Postal Code

81675

Country

Germany

Facility Name

Local Institution

City

Tuebingen

ZIP/Postal Code

72076

Country

Germany

Facility Name

Alexandra General Hospital Of Athens

City

Athens

ZIP/Postal Code

12462

Country

Greece

Facility Name

Euromedica General Clinic of Thessaloniki

City

Thessaloniki

ZIP/Postal Code

54645

Country

Greece

Facility Name

Local Institution

City

Tallaght

State/Province

Dublin

ZIP/Postal Code

DUBLIN 24

Country

Ireland

Facility Name

Local Institution - 0087

City

Dublin

ZIP/Postal Code

Country

Ireland

Facility Name

Local Institution

City

Dublin

ZIP/Postal Code

Dublin 7

Country

Ireland

Facility Name

Local Institution

City

Haifa

ZIP/Postal Code

31096

Country

Israel

Facility Name

Local Institution - 0148

City

Petah Tikva

ZIP/Postal Code

49100

Country

Israel

Facility Name

Local Institution

City

Ramat-gan

ZIP/Postal Code

52621

Country

Israel

Facility Name

Local Institution

City

Tel Aviv

ZIP/Postal Code

64239

Country

Israel

Facility Name

Local Institution

City

Arezzo

ZIP/Postal Code

52100

Country

Italy

Facility Name

Local Institution

City

Meldola (fc)

ZIP/Postal Code

47014

Country

Italy

Facility Name

Local Institution - 0082

City

Milano

ZIP/Postal Code

20133

Country

Italy

Facility Name

Local Institution

City

Rimini

ZIP/Postal Code

47900

Country

Italy

Facility Name

Local Institution

City

Roma

ZIP/Postal Code

00144

Country

Italy

Facility Name

Local Institution

City

Roma

ZIP/Postal Code

00152

Country

Italy

Facility Name

Local Institution - 0102

City

Rozzano

ZIP/Postal Code

20089

Country

Italy

Facility Name

Local Institution

City

Siena

ZIP/Postal Code

53100

Country

Italy

Facility Name

Local Institution

City

Terni

ZIP/Postal Code

05100

Country

Italy

Facility Name

Local Institution

City

Akita-shi

State/Province

Akita

ZIP/Postal Code

0108543

Country

Japan

Facility Name

Local Institution

City

Chiba-shi

State/Province

Chiba

ZIP/Postal Code

2608717

Country

Japan

Facility Name

Local Institution

City

Higashi-ku

State/Province

Fukuoka

ZIP/Postal Code

812-8582

Country

Japan

Facility Name

Local Institution

City

Sapporo-city

State/Province

Hokkaido

ZIP/Postal Code

0608543

Country

Japan

Facility Name

Local Institution

City

Sapporo-shi

State/Province

Hokkaido

ZIP/Postal Code

0608648

Country

Japan

Facility Name

Local Institution

City

Morioka-shi

State/Province

Iwate

ZIP/Postal Code

0208505

Country

Japan

Facility Name

Local Institution

City

Yokohama

State/Province

Kanagawa

ZIP/Postal Code

2360004

Country

Japan

Facility Name

Local Institution

City

Kyoto-shi

State/Province

Kyoto

ZIP/Postal Code

602-8566

Country

Japan

Facility Name

Local Institution

City

Osaka-sayama-shi

State/Province

Osaka

ZIP/Postal Code

5898511

Country

Japan

Facility Name

Local Institution - 0169

City

Suita

State/Province

Osaka

ZIP/Postal Code

5650871

Country

Japan

Facility Name

Local Institution - 0167

City

Hamamatsu-shi

State/Province

Shizuoka

ZIP/Postal Code

4313192

Country

Japan

Facility Name

Local Institution

City

Tokushima-shi

State/Province

Tokushima

ZIP/Postal Code

7708503

Country

Japan

Facility Name

Local Institution

City

Yamagata-shi

State/Province

Yamagata

ZIP/Postal Code

9909585

Country

Japan

Facility Name

Local Institution

City

Kobe-city, Hyogo

ZIP/Postal Code

650-0017

Country

Japan

Facility Name

Local Institution

City

Kumamoto

ZIP/Postal Code

860-8556

Country

Japan

Facility Name

Local Institution

City

Tokyo

ZIP/Postal Code

1138603

Country

Japan

Facility Name

Local Institution

City

Tokyo

ZIP/Postal Code

1138655

Country

Japan

Facility Name

Local Institution

City

Tokyo

ZIP/Postal Code

1358550

Country

Japan

Facility Name

Local Institution

City

Tokyo

ZIP/Postal Code

1608582

Country

Japan

Facility Name

Local Institution

City

Tokyo

ZIP/Postal Code

1628666

Country

Japan

Facility Name

Local Institution

City

Tokyo

ZIP/Postal Code

1738606

Country

Japan

Facility Name

Local Institution

City

Bergen

ZIP/Postal Code

5021

Country

Norway

Facility Name

Local Institution

City

Lorenskog

ZIP/Postal Code

1478

Country

Norway

Facility Name

Local Institution

City

Gdansk

ZIP/Postal Code

80-219

Country

Poland

Facility Name

Local Institution

City

Lodz

ZIP/Postal Code

93-513

Country

Poland

Facility Name

Local Institution

City

Poznan

ZIP/Postal Code

60-569

Country

Poland

Facility Name

Local Institution

City

Rybnik

ZIP/Postal Code

44-200

Country

Poland

Facility Name

Local Institution

City

Warszawa

ZIP/Postal Code

00-909

Country

Poland

Facility Name

Local Institution

City

Wroclaw

ZIP/Postal Code

50-556

Country

Poland

Facility Name

Local Institution

City

Bucharest

ZIP/Postal Code

022328

Country

Romania

Facility Name

Local Institution

City

Craiova

ZIP/Postal Code

200385

Country

Romania

Facility Name

Local Institution

City

Iasi

ZIP/Postal Code

700106

Country

Romania

Facility Name

Local Institution

City

Timisoara

ZIP/Postal Code

300167

Country

Romania

Facility Name

Local Institution

City

Moscow

ZIP/Postal Code

115478

Country

Russian Federation

Facility Name

Local Institution

City

Moscow

ZIP/Postal Code

121309

Country

Russian Federation

Facility Name

Local Institution

City

St Petersburg

ZIP/Postal Code

198255

Country

Russian Federation

Facility Name

Local Institution

City

Pamplona

State/Province

Navarra

ZIP/Postal Code

31008

Country

Spain

Facility Name

Local Institution

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Local Institution - 0064

City

Hospitalet De Llobregat

ZIP/Postal Code

08907

Country

Spain

Facility Name

Local Institution

City

Madrid

ZIP/Postal Code

28007

Country

Spain

Facility Name

Local Institution

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Local Institution

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

Local Institution

City

Gothenberg

ZIP/Postal Code

413 45

Country

Sweden

Facility Name

Local Institution

City

Solna

ZIP/Postal Code

171 64

Country

Sweden

Facility Name

Local Institution

City

Cambridge

State/Province

Cambridgeshire

ZIP/Postal Code

CB2 0QQ

Country

United Kingdom

Facility Name

Local Institution - 0048

City

Swansea

State/Province

Carmarthenshire

ZIP/Postal Code

SA2 8QA

Country

United Kingdom

Facility Name

Local Institution

City

Swansea

State/Province

Carmarthenshire

ZIP/Postal Code

SA2 8QA

Country

United Kingdom

Facility Name

Local Institution

City

London

State/Province

Greater London

ZIP/Postal Code

HA6 2RN

Country

United Kingdom

Facility Name

Local Institution

City

London

State/Province

Greater London

ZIP/Postal Code

SW3 6JJ

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

33428174

Citation

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.

Results Reference

derived

PubMed Identifier

31992108

Citation

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.

Results Reference

derived

PubMed Identifier

31272883

Citation

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.

Results Reference

derived

PubMed Identifier

30215677

Citation

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.

Results Reference

derived

PubMed Identifier

28410865

Citation

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.

Results Reference

derived

PubMed Identifier

28262413

Citation

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. Erratum In: Eur Urol. 2018 Jan 3;:

Results Reference

derived

PubMed Identifier

27283863

Citation

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. Erratum In: Lancet Oncol. 2016 Jul;17 (7):e270.

Results Reference

derived

PubMed Identifier

26406148

Citation

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.

Results Reference

derived

Links:

URL

https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Description

BMS Clinical Trial Information

URL

https://www.bmsstudyconnect.com/s/US/English/USenHome

Description

BMS Clinical Trial Patient Recruiting

URL

https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

Description

FDA Safety Alerts and Recalls

Learn more about this trial

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

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

Advanced or Metastatic (Medically or Surgically Unresectable) Clear-cell Renal Cell Carcinoma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial