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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03138512




Registration number
NCT03138512
Ethics application status
Date submitted
1/05/2017
Date registered
3/05/2017

Titles & IDs
Public title
A Study Comparing Nivolumab, Nivolumab in Combination With Ipilimumab and Placebo in Participants With Localized Kidney Cancer Who Underwent Surgery to Remove Part of a Kidney
Scientific title
A Phase 3 Randomized, Double-Blind Study of Nivolumab Monotherapy or Nivolumab Combined With Ipilimumab vs Placebo in Participants With Localized Renal Cell Carcinoma Who Underwent Radical or Partial Nephrectomy and Who Are at High Risk of Relapse
Secondary ID [1] 0 0
2016-004502-34
Secondary ID [2] 0 0
CA209-914
Universal Trial Number (UTN)
Trial acronym
CheckMate 914
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - nivolumab
Treatment: Other - ipilimumab
Treatment: Drugs - nivolumab placebo
Treatment: Drugs - ipilimumab placebo

Experimental: Part A, Arm A: nivolumab + ipilimumab -

Placebo comparator: Part A, Arm B: nivolumab placebo + ipilimumab placebo -

Experimental: Part B, Arm A: nivolumab + ipilimumab -

Placebo comparator: Part B, Arm B: nivolumab placebo + ipilimumab placebo -

Experimental: Part B, Arm C: nivolumab + ipilimumab placebo -


Treatment: Other: nivolumab
Specified dose on specified days

Treatment: Other: ipilimumab
Specified dose on specified days

Treatment: Drugs: nivolumab placebo
Specified dose on specified days

Treatment: Drugs: ipilimumab placebo
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Disease-Free Survival (DFS) by BICR - Treatment Part A and B
Timepoint [1] 0 0
From randomization to development of local disease recurrence, distance metastasis, or death, whichever came first (up to approximately 72 months)
Secondary outcome [1] 0 0
Overall Survival (OS) - Treatment Part A and B
Timepoint [1] 0 0
From randomization to the date of death (up to approximately 72 months)
Secondary outcome [2] 0 0
Overall Survival (OS) Rate (5 Years) - Treatment Part A and B
Timepoint [2] 0 0
At 5 years
Secondary outcome [3] 0 0
Disease-Free Survival (DFS) Per BICR in Contemporaneously Randomized Combination and Monotherapy Participants - Treatment Part B
Timepoint [3] 0 0
From randomization to development of local disease recurrence, distance metastasis, or death, whichever came first (up to approximately 72 months)
Secondary outcome [4] 0 0
Overall Survival (OS) in the Contemporaneously Randomized Combination and Monotherapy Participants - Treatment Part B
Timepoint [4] 0 0
From randomization to the date of death (up to approximately 72 months)
Secondary outcome [5] 0 0
The Number of Participants With Adverse Events up to 30 Days After Last Dose of Study Therapy - Treatment Part A
Timepoint [5] 0 0
From first dose to 30 days post last dose (up to approximately 40 weeks)
Secondary outcome [6] 0 0
The Number of Participants With Adverse Events up to 30 Days After Last Dose of Study Therapy - Treatment Part B
Timepoint [6] 0 0
From first dose to 30 days post last dose (up to approximately 40 weeks)
Secondary outcome [7] 0 0
The Number of Participants With Adverse Events up to 100 Days After Last Dose of Study Therapy - Treatment Part A
Timepoint [7] 0 0
From first dose to 100 days post last dose (up to approximately 50 weeks)
Secondary outcome [8] 0 0
The Number of Participants With Adverse Events up to 100 Days After Last Dose of Study Therapy - Treatment Part B
Timepoint [8] 0 0
From first dose to 100 days post last dose (up to approximately 50 weeks)
Secondary outcome [9] 0 0
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part A
Timepoint [9] 0 0
From first dose to 30 days post last dose (up to approximately 40 weeks)
Secondary outcome [10] 0 0
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B
Timepoint [10] 0 0
From first dose to 30 days post last dose (up to approximately 40 weeks)
Secondary outcome [11] 0 0
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part A
Timepoint [11] 0 0
From first dose to 100 days post last dose (up to approximately 50 weeks)
Secondary outcome [12] 0 0
The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B
Timepoint [12] 0 0
From first dose to 100 days post last dose (up to approximately 50 weeks)

Eligibility
Key inclusion criteria
* Kidney tumor has been completely resected with negative surgical margins obtained. The randomization must occur greater than 4 weeks and less than (or equal to) 12 weeks from the date of nephrectomy
* Pathologic tumor, node, and metastasis (TNM) staging meeting one of the following: pT2a, G3 or G4, N0 M0; pT2b, G any, N0 M0; pT3, (a, b, c), G any, N0 M0; pT4, G any, N0 M0; pT any, G any, N1 M0
* Post-nephrectomy tumor shows renal cell cancer (RCC) with a predominantly clear cell histology, including participants with sarcomatoid features
* Participants must have no clinical or radiological evidence of macroscopic residual disease or distant metastases after nephrectomy
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1
* Women must agree to follow methods of contraception, if applicable
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Participants with an active known or suspected autoimmune disease
* Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
* Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
* Any severe or serious, acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation
* History of allergy or hypersensitivity to study drug components
* Participants with a condition requiring systemic treatment with corticosteroids
* Participants who have received a live/attenuated vaccine within 30 days of first treatment

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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
7/07/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2024
Sample size
Target
Accrual to date
Final
1641
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - 0215 - Macquarie Park
Recruitment hospital [2] 0 0
Local Institution - 0032 - Northmead
Recruitment hospital [3] 0 0
Local Institution - 0036 - Randwick
Recruitment hospital [4] 0 0
Local Institution - 0035 - St Leonards
Recruitment hospital [5] 0 0
Local Institution - 0113 - South Brisbane
Recruitment hospital [6] 0 0
Local Institution - 0213 - Southport
Recruitment hospital [7] 0 0
Local Institution - 0034 - Elizabeth Vale
Recruitment hospital [8] 0 0
Local Institution - 0033 - Clayton
Recruitment hospital [9] 0 0
Local Institution - 0214 - Heidelberg
Recruitment hospital [10] 0 0
Local Institution - 0031 - Murdoch
Recruitment postcode(s) [1] 0 0
2109 - Macquarie Park
Recruitment postcode(s) [2] 0 0
2152 - Northmead
Recruitment postcode(s) [3] 0 0
2031 - Randwick
Recruitment postcode(s) [4] 0 0
2065 - St Leonards
Recruitment postcode(s) [5] 0 0
4101 - South Brisbane
Recruitment postcode(s) [6] 0 0
4215 - Southport
Recruitment postcode(s) [7] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [8] 0 0
0 - Clayton
Recruitment postcode(s) [9] 0 0
3084 - Heidelberg
Recruitment postcode(s) [10] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
New Jersey
Country [9] 0 0
United States of America
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New York
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United States of America
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Ohio
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Oregon
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Pennsylvania
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South Carolina
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United States of America
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Tennessee
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United States of America
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Virginia
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Argentina
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Buenos Aires
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Argentina
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Cordoba
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Argentina
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RIO Negro
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Argentina
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Caba
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Argentina
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San Juan
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Argentina
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Tucuman
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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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Oost-Vlaanderen
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Anderlecht
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Belgium
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Hasselt
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Belgium
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Liege
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Brazil
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Distrito Federal
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Brazil
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Minas Gerais
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Brazil
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RIO Grande DO SUL
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Brazil
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Sao Paulo
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Brazil
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SAO Paulo
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Brazil
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Rio de Janeiro
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Canada
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British Columbia
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Canada
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New Brunswick
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Canada
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Ontario
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Canada
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Quebec
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Chile
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Coquimbo
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Chile
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Metropolitana
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Chile
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Valparaiso
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China
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Beijing
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China
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Fujian
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Guangdong
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China
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Hubei
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China
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Jiangsu
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Jiangxi
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Jilin
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Shan3xi
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Zhejiang
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Colombia
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Antioquia
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Cesar
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Colombia
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Bogotá
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Colombia
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Floridablanca
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Colombia
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Pereira
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Czechia
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Hradec Kralove
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Czechia
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Olomouc
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Besançon Cedex
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Bordeaux
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La Roche-Sur-Yon Cedex 9
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France
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Lyon Cedex 08
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Marseille Cedex 9
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Paris
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Rennes
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Toulouse Cedex 9
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Tours Cedex
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Vandoeuvre Les Nancy
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Villejuif
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Baden-Württemberg
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Aachen
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Essen
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Hamburg
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Hannover
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Jena
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Nuernberg
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Germany
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Rostock
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Germany
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Wuerzburg
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Italy
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Arezzo
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Italy
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Cremona
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Italy
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Napoli
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Italy
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Parma
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Italy
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Roma
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Italy
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Verona
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Japan
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Aichi
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Japan
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Aomori
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Japan
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Chiba
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Fukuoka
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Hokkaido
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Hyogo
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Ibaraki
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Japan
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Iwate
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Japan
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Kanagawa
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Japan
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Kumamoto
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Japan
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Kyoto
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Nagasaki
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Niigata
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Osaka
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Tokushima
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Tokyo
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Yamaguchi
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Hiroshima
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Wakayama
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Yamagata
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Mexico
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BAJA California
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Chiapas
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Coahuila
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Jalisco
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Sinaloa
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Mexico
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Yucatan
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Mexico
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Chihuahua
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Mexico
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Monterrey, NL
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Mexico
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San Luis Potosi
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Netherlands
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Amsterdam
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Netherlands
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Rotterdam
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Netherlands
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Zwolle
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Poland
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Bydgoszcz
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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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Cluj-Napoca
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Romania
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Cluj
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Romania
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Craiova
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Romania
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Ia?i
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Russian Federation
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Moscow
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Russian Federation
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Novosibirsk
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Russian Federation
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Saint-Petersburg
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Singapore
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Central Singapore
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Singapore
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Singapore
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Spain
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Barcelona
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Spain
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Caceres
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Spain
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Cordoba
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Spain
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Lugo
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Spain
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Madrid
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Spain
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Sabadell
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Spain
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Sevilla
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Switzerland
State/province [144] 0 0
Chur
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Switzerland
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Sankt Gallen
Country [146] 0 0
Switzerland
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Zuerich
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Turkey
State/province [147] 0 0
Ankara
Country [148] 0 0
Turkey
State/province [148] 0 0
Istanbul
Country [149] 0 0
United Kingdom
State/province [149] 0 0
Hampshire
Country [150] 0 0
United Kingdom
State/province [150] 0 0
Manchester
Country [151] 0 0
United Kingdom
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Northwood
Country [152] 0 0
United Kingdom
State/province [152] 0 0
Preston
Country [153] 0 0
United Kingdom
State/province [153] 0 0
Swansea

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03138512