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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03661320




Registration number
NCT03661320
Ethics application status
Date submitted
5/09/2018
Date registered
7/09/2018
Date last updated
30/01/2024

Titles & IDs
Public title
A Study to Compare Chemotherapy Alone Versus Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Therapy After Surgery With Nivolumab or Nivolumab and BMS-986205 in Participants With Muscle Invasive Bladder Cancer
Scientific title
A Phase 3, Randomized, Study of Neoadjuvant Chemotherapy Alone Versus Neoadjuvant Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Post- Surgery Therapy With Nivolumab or Nivolumab and BMS-986205 in Participants With Muscle- Invasive Bladder Cancer
Secondary ID [1] 0 0
2017-004692-31
Secondary ID [2] 0 0
CA017-078
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Urinary Bladder Neoplasms 0 0
Muscle-Invasive Bladder Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bladder - transitional cell cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Nivolumab
Treatment: Drugs - Gemcitabine
Treatment: Drugs - Cisplatin

Active comparator: Arm A: Gemcitabine/Cisplatin (GC) Chemotherapy -

Experimental: Arm B: Nivolumab + GC Chemotherapy -


Treatment: Other: Nivolumab
Specified dose on specified days

Treatment: Drugs: Gemcitabine
Specified dose on specified days

Treatment: Drugs: Cisplatin
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
Pathological Complete Response (pCR) rate, in all randomized participants
Timepoint [1] 0 0
Approximately 43 months
Primary outcome [2] 0 0
Event-Free Survival (EFS), in all randomized participants
Timepoint [2] 0 0
Approximately 51 months
Secondary outcome [1] 0 0
Overall Survival (OS) in all randomized participants
Timepoint [1] 0 0
Approximately 60 months
Secondary outcome [2] 0 0
Incidence of Adverse Events (AE) in participants who received at least one treatment dose
Timepoint [2] 0 0
Approximately 60 months
Secondary outcome [3] 0 0
Incidence of Serious Adverse Events (SAE) in participants who received at least one treatment dose
Timepoint [3] 0 0
Approximately 60 months
Secondary outcome [4] 0 0
Incidence of deaths in participants who received at least one treatment dose
Timepoint [4] 0 0
Approximately 60 months
Secondary outcome [5] 0 0
Incidence of laboratory abnormalities in participants who received at least one treatment dose
Timepoint [5] 0 0
Approximately 60 months
Secondary outcome [6] 0 0
pCR rate, descriptively in all concurrently randomized participants
Timepoint [6] 0 0
Approximately 43 months
Secondary outcome [7] 0 0
EFS, descriptively in all concurrently randomized participants
Timepoint [7] 0 0
Approximately 51 months
Secondary outcome [8] 0 0
OS, descriptively in all concurrently randomized participants
Timepoint [8] 0 0
Approximately 60 months

Eligibility
Key inclusion criteria
* Participant must be deemed eligible for Radial Cystectomy (RC) by his/her oncologist and/or urologist, and must agree to undergo Radial Cystectomy (RC) after completion of neoadjuvant therapy.
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Clinical evidence of positive lymph node(s) (LN) (= 10 mm in short axis) or metastatic bladder cancer
* Prior systemic therapy, radiation therapy, or surgery for bladder cancer other than trans urethral resection of bladder tumor (TURBT) or biopsies is also not permitted

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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/11/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/12/2027
Actual
Sample size
Target
Accrual to date
Final
861
Recruitment in Australia
Recruitment state(s)
ACT,NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - 0131 - Garran
Recruitment hospital [2] 0 0
Local Institution - 0130 - Kingswood
Recruitment hospital [3] 0 0
Local Institution - 0157 - Macquarie University
Recruitment hospital [4] 0 0
Local Institution - 0043 - St Leonards
Recruitment hospital [5] 0 0
Local Institution - 0143 - North Adelaide
Recruitment hospital [6] 0 0
Local Institution - 0037 - Heidelberg
Recruitment hospital [7] 0 0
Local Institution - 0038 - Murdoch
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2747 - Kingswood
Recruitment postcode(s) [3] 0 0
2109 - Macquarie University
Recruitment postcode(s) [4] 0 0
2065 - St Leonards
Recruitment postcode(s) [5] 0 0
5006 - North Adelaide
Recruitment postcode(s) [6] 0 0
3084 - Heidelberg
Recruitment postcode(s) [7] 0 0
6150 - Murdoch
Recruitment outside Australia
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United States of America
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Arizona
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Tennessee
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Texas
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Virginia
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Buenos Aires
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Argentina
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Distrito Federal
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Austria
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Klagenfurt Am Woerthersee
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Krems
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Linz
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Wilrijk
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Frankfurt Main
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Goettingen
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Herne
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Jena
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Luebeck
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Magdeburg
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Muenchen
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Nuernberg
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Trier
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Chaidari
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Aichi
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Portugal
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Lisboa
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Porto
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Romania
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Cluj-Napoca
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Romania
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Craiova
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Romania
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Sector 2
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Russian Federation
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Saint-Petersburg
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Russian Federation
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St Petersburg
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Singapore
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Singapore
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Spain
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Lugo
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Madrid
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Malaga
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Sevilla
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Taiwan
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Taipei City
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Taiwan
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Taipei
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United Kingdom
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Essex
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United Kingdom
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Yorkshire
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Glasgow
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Lancaster
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London
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United Kingdom
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Oxford

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 compare nivolumab plus neoadjuvant gemcitabine/cisplatin (GC) chemotherapy, followed by post-surgery continuation of immuno-oncology (IO) therapy, with neoadjuvant GC chemotherapy alone in adult participants with previously untreated muscle-invasive bladder cancer (MIBC).
Trial website
https://clinicaltrials.gov/study/NCT03661320
Trial related presentations / publications
Sonpavde G, Necchi A, Gupta S, Steinberg GD, Gschwend JE, Van Der Heijden MS, Garzon N, Ibrahim M, Raybold B, Liaw D, Rutstein M, Galsky MD. ENERGIZE: a Phase III study of neoadjuvant chemotherapy alone or with nivolumab with/without linrodostat mesylate for muscle-invasive bladder cancer. Future Oncol. 2020 Jan;16(2):4359-4368. doi: 10.2217/fon-2019-0611. Epub 2019 Dec 11.
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/NCT03661320