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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02632409




Registration number
NCT02632409
Ethics application status
Date submitted
14/12/2015
Date registered
16/12/2015
Date last updated
8/01/2024

Titles & IDs
Public title
An Investigational Immuno-therapy Study of Nivolumab, Compared to Placebo, in Patients With Bladder or Upper Urinary Tract Cancer, Following Surgery to Remove the Cancer
Scientific title
A Phase 3 Randomized, Double-blind, Multi-center Study of Adjuvant Nivolumab Versus Placebo in Subjects With High Risk Invasive Urothelial Carcinoma (CheckMate 274: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 274)
Secondary ID [1] 0 0
2014-003626-40
Secondary ID [2] 0 0
CA209-274
Universal Trial Number (UTN)
Trial acronym
CheckMate 274
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Various Advanced Cancer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: Nivolumab - Nivolumab dose as specified

Placebo comparator: Placebo - Placebo dose as specified
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Disease Free Survival (DFS)
Timepoint [1] 0 0
approximately up to 48 months
Primary outcome [2] 0 0
Disease Free Survival (DFS) in PD-L1 Expression = 1% Population
Timepoint [2] 0 0
approximately up to 48 months
Secondary outcome [1] 0 0
Non-Urothelial Tract Recurrence Free Survival
Timepoint [1] 0 0
up to 53 months
Secondary outcome [2] 0 0
Non-Urothelial Tract Recurrence Free Survival in PD-L1 Expression = 1% Population
Timepoint [2] 0 0
up to 53 months
Secondary outcome [3] 0 0
Overall Survival
Timepoint [3] 0 0
on going
Secondary outcome [4] 0 0
Overall Survival in Participants With PD-L1 Expression = 1%
Timepoint [4] 0 0
on going
Secondary outcome [5] 0 0
Disease Specific Survival
Timepoint [5] 0 0
on going
Secondary outcome [6] 0 0
Disease Specific Survival in Participants With PD-L1 Expression = 1%
Timepoint [6] 0 0
on going

Eligibility
Key inclusion criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com



* Must have had invasive urothelial cancer at high risk of recurrence originating in the bladder, ureter, or renal pelvis
* Must have had radical surgical resection (e.g. radical cystectomy), performed within the last 120 days
* Must have disease free status as determined by imaging within 4 weeks of dosing
* Tumor tissue must be provided for biomarker analysis
* Patients who have not received prior neoadjuvant cisplatin chemotherapy must be ineligible for or refuse cisplatin-based adjuvant chemotherapy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Partial bladder or partial kidney removal (eg, partial cystectomy or partial nephrectomy)
* Secondary Treatment (eg, adjuvant systemic chemotherapy for bladder cancer) following surgical removal of bladder cancer
* Subjects with active, known or suspected autoimmune disease
* Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured
* Condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 day of study drug administration
* Positive test for hepatitis B virus surface antigen (HBV s Ag) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection

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

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/03/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
27/05/2027
Actual
Sample size
Target
Accrual to date
Final
709
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - 0048 - Liverpool
Recruitment hospital [2] 0 0
Local Institution - 0047 - St. Leonards
Recruitment hospital [3] 0 0
Local Institution - 0046 - Waratah
Recruitment hospital [4] 0 0
Local Institution - 0050 - Elizabeth Vale
Recruitment hospital [5] 0 0
Local Institution - 0184 - Frankston
Recruitment hospital [6] 0 0
Local Institution - 0175 - Perth
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
2065 - St. Leonards
Recruitment postcode(s) [3] 0 0
2298 - Waratah
Recruitment postcode(s) [4] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [5] 0 0
3199 - Frankston
Recruitment postcode(s) [6] 0 0
6150 - Perth
Recruitment outside Australia
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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
The purpose of this study is to determine the effectiveness and safety of Nivolumab compared to placebo in participants who have undergone radical surgery for invasive urothelial cancer.
Trial website
https://clinicaltrials.gov/study/NCT02632409
Trial related presentations / publications
Bajorin DF, Witjes JA, Gschwend JE, Schenker M, Valderrama BP, Tomita Y, Bamias A, Lebret T, Shariat SF, Park SH, Ye D, Agerbaek M, Enting D, McDermott R, Gajate P, Peer A, Milowsky MI, Nosov A, Neif Antonio J Jr, Tupikowski K, Toms L, Fischer BS, Qureshi A, Collette S, Unsal-Kacmaz K, Broughton E, Zardavas D, Koon HB, Galsky MD. Adjuvant Nivolumab versus Placebo in Muscle-Invasive Urothelial Carcinoma. N Engl J Med. 2021 Jun 3;384(22):2102-2114. doi: 10.1056/NEJMoa2034442. Erratum In: N Engl J Med. 2021 Aug 26;385(9):864. doi: 10.1056/NEJMx210012.
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/NCT02632409