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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01668784




Registration number
NCT01668784
Ethics application status
Date submitted
16/08/2012
Date registered
20/08/2012
Date last updated
9/08/2022

Titles & IDs
Public title
Study of Nivolumab (BMS-936558) vs. Everolimus in Pre-Treated Advanced or Metastatic Clear-cell Renal Cell Carcinoma (CheckMate 025)
Scientific 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
Secondary ID [1] 0 0
2011-005132-26
Secondary ID [2] 0 0
CA209-025
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced or Metastatic (Medically or Surgically Unresectable) Clear-cell Renal Cell Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Experimental: Arm 1: Nivolumab - Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends

Active comparator: Arm 2: Everolimus - Everolimus 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS) at Primary Endpoint
Timepoint [1] 0 0
Randomization until 398 deaths, up to May 2015 (approximately 30 months)
Secondary outcome [1] 0 0
Investigator-assessed Objective Response Rate (ORR)
Timepoint [1] 0 0
from randomization up to disease progression or death (approximately up to 105 Months)
Secondary outcome [2] 0 0
Investigator-assessed Duration of Objective Response
Timepoint [2] 0 0
From randomization to date of disease progression or death or censoring if no progression or death occurred (approximately 105 months)
Secondary outcome [3] 0 0
Investigator-assessed Time to Objective Response
Timepoint [3] 0 0
Randomization to date of first response (approximately 105 months)
Secondary outcome [4] 0 0
Investigator-assessed Time of Progression-free Survival (PFS)
Timepoint [4] 0 0
from randomization up to disease progression or death (approximately up to 105 Months)
Secondary outcome [5] 0 0
Overall Survival (OS) by Programmed Death-Ligand 1 (PD-L1) Expression Level
Timepoint [5] 0 0
Randomization to date of death or date of last contact for patients without documentation of death, up to May 2015 (approximately 30 months)
Secondary outcome [6] 0 0
Number of Participants With Serious Adverse Events, Death, Discontinuation Due to Adverse Events
Timepoint [6] 0 0
Day of first dose to 30 days post study completion (approximately 106 months)
Secondary outcome [7] 0 0
Percentage of Participants With Disease-related Symptom Progression (DRSP)
Timepoint [7] 0 0
from randomization up to disease progression or death (approximately up to 105 Months)
Secondary outcome [8] 0 0
Number of Participants Meeting Marked Laboratory Abnormality Criteria in Specific Liver and Thyroid Tests
Timepoint [8] 0 0
Day 1 to 30 days post study completion (approximately 106 months)
Secondary outcome [9] 0 0
Number of Participants With Abnormal Hematology and Serum Chemistry Laboratory Parameters by Worse CTC Grade - SI Units
Timepoint [9] 0 0
Day 1 to 30 days post study completion (approximately 106 months)

Eligibility
Key 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%
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/10/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/07/2021
Sample size
Target
Accrual to date
Final
821
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Local Institution - 0095 - Westmead
Recruitment hospital [2] 0 0
Local Institution - Woodville South
Recruitment hospital [3] 0 0
Local Institution - Box Hill
Recruitment hospital [4] 0 0
Local Institution - Clayton
Recruitment hospital [5] 0 0
Local Institution - Melbourne
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
5011 - Woodville South
Recruitment postcode(s) [3] 0 0
3128 - Box Hill
Recruitment postcode(s) [4] 0 0
3168 - Clayton
Recruitment postcode(s) [5] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
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United States of America
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California
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United States of America
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Colorado
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District of Columbia
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Illinois
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Indiana
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Iowa
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United States of America
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Maryland
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Massachusetts
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Michigan
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New Hampshire
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New York
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North Carolina
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Ohio
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Virginia
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Washington
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Argentina
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Buenos Aires
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Argentina
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Tucuman
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Argentina
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Cordoba
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Austria
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Linz
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Austria
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Wien
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Belgium
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Brussels
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Belgium
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Bruxelles
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Gent
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Leuven
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RIO Grande DO SUL
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New Brunswick
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Nova Scotia
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Ontario
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Quebec
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Montreal
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Czechia
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Hradec Kralove
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Olomouc
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Czechia
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Prague 5
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Aarhus N
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Denmark
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Herlev
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Marseille Cedex 9
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Poitiers
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Toulouse Cedex 9
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Vandoeuvre Les Nancy
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Aachen
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Dresden
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Germany
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Erlangen
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Germany
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Essen
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Germany
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Hannover
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Germany
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Heidelberg
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Germany
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Munich
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Germany
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Tuebingen
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Greece
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Athens
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Greece
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Thessaloniki
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Ireland
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Haifa
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Petah Tikva
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Israel
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Ramat-gan
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Israel
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Tel Aviv
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Italy
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Arezzo
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Italy
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Meldola (fc)
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Milano
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Italy
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Rimini
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Roma
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Rozzano
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Italy
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Siena
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Terni
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Akita
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Chiba
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Fukuoka
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Hokkaido
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Iwate
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Kanagawa
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Kyoto
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Osaka
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Shizuoka
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Tokushima
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Yamagata
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Japan
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Kobe-city, Hyogo
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Japan
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Kumamoto
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Japan
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Tokyo
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Norway
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Bergen
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Norway
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Lorenskog
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Poland
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Gdansk
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Lodz
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Poznan
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Rybnik
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Warszawa
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Poland
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Wroclaw
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Romania
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Bucharest
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Romania
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Craiova
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Romania
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Iasi
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Romania
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Timisoara
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Russian Federation
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Moscow
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Russian Federation
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St Petersburg
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Spain
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Navarra
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Spain
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Barcelona
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Spain
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Hospitalet De Llobregat
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Spain
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Madrid
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Sweden
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Gothenberg
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Sweden
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Solna
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United Kingdom
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Cambridgeshire
Country [116] 0 0
United Kingdom
State/province [116] 0 0
Carmarthenshire
Country [117] 0 0
United Kingdom
State/province [117] 0 0
Greater London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Ono Pharmaceutical Co. Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01668784