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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03138512
Ethics application status
Date submitted
1/05/2017
Date registered
3/05/2017
Date last updated
14/08/2019

Titles & IDs
Public title
A Study Comparing the Combination of Nivolumab and Ipilimumab Versus Placebo in Participants With Localized Renal Cell Carcinoma
Scientific title
A Phase 3 Randomized Study Comparing Nivolumab and Ipilimumab Combination 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:
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
Description of intervention(s) / exposure
Other interventions - Nivolumab
Other interventions - Ipilimumab
Treatment: Drugs - Placebo

Experimental: Module A: Nivolumab + Ipilimumab -

Placebo Comparator: Module B: Placebo -


Other interventions: Nivolumab
Specified dose on specified days for 24 weeks

Other interventions: Ipilimumab
Specified dose on specified days for 24 weeks

Treatment: Drugs: Placebo
Specified dose on specified days for 24 weeks

Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Disease-free survival (DFS) - Per Blinded Independent Central Review (BICR)
Timepoint [1] 0 0
Up to 5 years
Secondary outcome [1] 0 0
Overall Survival (OS) - Defined as the time between the date of randomization and the date of death
Timepoint [1] 0 0
Up to 5 years
Secondary outcome [2] 0 0
Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 - Safety and Tolerability
Timepoint [2] 0 0
Up to 5 years

Eligibility
Key inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com

- Kidney tumor has been completely resected 4 to 12 weeks prior to randomization

- Pathologic TNM staging meeting one of the following: pT2a, G3 or G4, N0 M0; pT2b, G
any, N0 M0; pT3, G any, N0 M0; pT4, G any, N0 M0; pT any, G any, N1 M0

- Post-nephrectomy tumor shows RCC with a predominantly clear cell histology, including
participants with sarcomatoid features
Minimum age
18 Years
Maximum age
No limit
Gender
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)

- Any severe or serious, acute or chronic medical or psychiatric condition, or
laboratory abnormality that may increase the risk associated with study participation

- Participants with a condition requiring systemic treatment with corticosteroids

Other protocol defined inclusion/exclusion criteria could 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 analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Prince Of Wales Hospital - Randwick
Recruitment hospital [2] 0 0
Royal North Shore Hospital - Sydney
Recruitment hospital [3] 0 0
Westmead Hospital - Westmead
Recruitment hospital [4] 0 0
Integrated Clinical Oncology Network Pty Ltd (ICON) - Chermside
Recruitment hospital [5] 0 0
Cabrini Hospital - Malvern
Recruitment hospital [6] 0 0
St John of God Murdoch Hospital - Perth
Recruitment hospital [7] 0 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
2065 - Sydney
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
4032 - Chermside
Recruitment postcode(s) [5] 0 0
3144 - Malvern
Recruitment postcode(s) [6] 0 0
6150 - Perth
Recruitment postcode(s) [7] 0 0
5112 - Elizabeth Vale
Recruitment outside Australia
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Preston

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

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine whether the combination of nivolumab and ipilimumab
is safe and effective for delaying or preventing recurrence of cancer in patients who have
experienced the partial or entire removal of a kidney
Trial website
https://clinicaltrials.gov/show/NCT03138512
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
Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,
Address 0 0
Country 0 0
Phone 0 0
please email:
Fax 0 0
Email 0 0
Clinical.Trials@bms.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03138512