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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
Date last updated
13/02/2024

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) as assessed by BICR (Part A and Part B)
Timepoint [1] 0 0
Up to 10 years
Secondary outcome [1] 0 0
Overall Survival (OS) (Part A and Part B)
Timepoint [1] 0 0
Up to 10 years
Secondary outcome [2] 0 0
Incidence of Adverse Events (AEs) (Part A and Part B)
Timepoint [2] 0 0
Up to 100 days after the last dose of study treatment
Secondary outcome [3] 0 0
Disease-Free Survival (DFS) as assessed by BICR (Part B: arm A vs. arm C)
Timepoint [3] 0 0
Up to 10 years

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
1653
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
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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 nivolmab alone or the combination of nivolumab and ipilimumab versus placebo, is safe and effective for delaying or preventing recurrence of cancer in participants who have experienced partial or entire removal of a kidney.
Trial website
https://clinicaltrials.gov/study/NCT03138512
Trial related presentations / publications
Marconi L, Sun M, Beisland C, Klatte T, Ljungberg B, Stewart GD, Dabestani S, Choueiri TK, Bex A. Prevalence, Disease-free, and Overall Survival of Contemporary Patients With Renal Cell Carcinoma Eligible for Adjuvant Checkpoint Inhibitor Trials. Clin Genitourin Cancer. 2021 Apr;19(2):e92-e99. doi: 10.1016/j.clgc.2020.12.005. Epub 2021 Jan 7.
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



Summary Results

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