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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03661320
Ethics application status
Date submitted
5/09/2018
Date registered
7/09/2018
Date last updated
28/08/2020

Titles & IDs
Public title
A Study of Chemo Only Versus Chemo Plus Nivo With or Without BMS-986205, Followed by Post- Surgery Therapy With Nivo or Nivo and BMS-986205 in Patients With MIBC
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:
Bladder Cancer 0 0
Muscle-Invasive Bladder Cancer 0 0
BMS-986205 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
Other interventions - Nivolumab
Treatment: Drugs - BMS-986205
Treatment: Drugs - Gemcitabine
Treatment: Drugs - Cisplatin
Treatment: Drugs - BMS-986205 Placebo

Active Comparator: Arm A - Chemotherapy alone followed by radical cystectomy

Experimental: Arm B - BMS-986205 Placebo + Nivolumab + Chemotherapy followed by BMS-986205 Placebo + Nivolumab post radical cystectomy

Experimental: Arm C - BMS-986205 + Nivolumab + Chemotherapy followed by Nivolumab plus BMS-986205 post radical cystectomy


Other interventions: Nivolumab
Specified dose on specified day

Treatment: Drugs: BMS-986205
Specified dose on specified day

Treatment: Drugs: Gemcitabine
Specified dose on specified day

Treatment: Drugs: Cisplatin
Specified dose on specified day

Treatment: Drugs: BMS-986205 Placebo
Specified dose on specified day

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
Pathological Complete Response (pCR) rate, in all randomized participants - Comparison of Arm B to Arm A; and Comparison of Arm C to Arm A
Timepoint [1] 0 0
Approx. 39 months
Primary outcome [2] 0 0
Event-Free Survival (EFS), in all randomized participants - Comparison of Arm B to Arm A; and Comparison of Arm C to Arm A;
Timepoint [2] 0 0
Approx. 57 months
Secondary outcome [1] 0 0
Overall Survival (OS) in all randomized participants - Comparison of Arm C vs Arm A; and Comparison of Arm B vs Arm A
Timepoint [1] 0 0
Approx. 76 months
Secondary outcome [2] 0 0
Incidence of Adverse Events (AE) in all treated participants
Timepoint [2] 0 0
Approx. 76 months
Secondary outcome [3] 0 0
Incidence of Serious Adverse Events (SAE) in all treated participants
Timepoint [3] 0 0
Approx. 76 months
Secondary outcome [4] 0 0
Incidence of Laboratory abnormalities in all treated participants
Timepoint [4] 0 0
Approx. 76 months
Secondary outcome [5] 0 0
Incidence of death in all treated participants
Timepoint [5] 0 0
Approx. 76 months
Secondary outcome [6] 0 0
Pathological Complete Response (pCR) rate, in all randomized participants - Comparison of Arm B v Arm C
Timepoint [6] 0 0
Approx. 39 months
Secondary outcome [7] 0 0
Event Free Survival (EFS), in all randomized participants - Comparison of Arm B v Arm C
Timepoint [7] 0 0
Approx. 57 months

Eligibility
Key inclusion criteria
- Participants with MIBC, clinical stage T2-T4a, N0 (<10 mm on CT or MRI), M0, diagnosed
at TURBT and confirmed by radiographic imaging. Variant histology is acceptable if
there is a predominant urothelial component.

- 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
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Clinical evidence of positive LN (= 10 mm in short axis) or metastatic bladder cancer

- Prior systemic therapy, radiation therapy, or surgery for bladder cancer other than
TURBT or biopsies is also not permitted

- Ineligible to receive cisplatin due to Grade 2 or higher peripheral neuropathy or
audiometric hearing loss, or calculated (Cockcroft-Gault formula) GFR or measured
(24-hour urine) creatinine clearance (CrCl) < 50 mL/min

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
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)
ACT,NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - Garran
Recruitment hospital [2] 0 0
Local Institution - Kingswood
Recruitment hospital [3] 0 0
Macquarie University - Macquarie Park
Recruitment hospital [4] 0 0
Northern Cancer institute - St Leonards
Recruitment hospital [5] 0 0
Calvary Hospital - North Adelaide
Recruitment hospital [6] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [7] 0 0
St John of God Murdoch Hospital - 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 Park
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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Krems
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Linz
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Lancaster
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Oxford

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

Ethics approval
Ethics application status

Summary
Brief summary
A study to evaluate nivolumab + chemotherapy or nivolumab/ BMS-986205 + chemotherapy followed
by continued Immuno-Oncology therapy after radical cystectomy (RC) compared with neoadjuvant
standard of care (SOC) chemotherapy alone in patients with muscle-invasive bladder cancer
(MIBC)
Trial website
https://clinicaltrials.gov/show/NCT03661320
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/NCT03661320