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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04100018




Registration number
NCT04100018
Ethics application status
Date submitted
20/09/2019
Date registered
23/09/2019
Date last updated
5/02/2020

Titles & IDs
Public title
A Study of Nivolumab or Placebo in Combination With Docetaxel in Men With Advanced Castration-resistant Prostate Cancer
Scientific title
A Phase 3, Randomized, Double-Blind Study of Nivolumab or Placebo in Combination With Docetaxel, in Men With Metastatic Castration-resistant Prostate Cancer
Secondary ID [1] 0 0
CA209-7DX
Universal Trial Number (UTN)
Trial acronym
CheckMate 7DX
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - nivolumab
Treatment: Drugs - prednisone
Treatment: Drugs - docetaxel

Experimental: Arm A: (nivolumab + docetaxel + prednisone) -

Active Comparator: Arm B: (placebo + docetaxel + prednisone) -


Other interventions: nivolumab
specified dose on specified days

Treatment: Drugs: prednisone
specified dose on specified days

Treatment: Drugs: docetaxel
specified dose on specified days

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
Radiographic progression-free survival (rPFS) per Prostate Cancer Working Group (PCWG3)
Timepoint [1] 0 0
Approxmiately 2 years
Primary outcome [2] 0 0
Overall Survival (OS)
Timepoint [2] 0 0
Approxmiately 3 years
Secondary outcome [1] 0 0
Objective Response Rate (ORR) per Prostate Cancer Working Group (PCWG3)
Timepoint [1] 0 0
Approxmiately 3 years
Secondary outcome [2] 0 0
Duration of response (DOR) per Prostate Cancer Working Group (PCWG3)
Timepoint [2] 0 0
Approxmiately 3 years
Secondary outcome [3] 0 0
PSA Response Rate (PSA-RR)
Timepoint [3] 0 0
Approxmiately 3 years
Secondary outcome [4] 0 0
Time to Response per PCWG3 (TTR-PCWG3) assessed by BICR
Timepoint [4] 0 0
Approxmiately 3 years
Secondary outcome [5] 0 0
Time to pain progression
Timepoint [5] 0 0
Approxmiately 3 years
Secondary outcome [6] 0 0
Time to PSA Progression (TTP-PSA)
Timepoint [6] 0 0
Approxmiately 3 years
Secondary outcome [7] 0 0
Incidence of AEs (Adverse Events)
Timepoint [7] 0 0
Approxmiately 3 years
Secondary outcome [8] 0 0
Incidence of SAEs ( Serious Adverse Events)
Timepoint [8] 0 0
Approxmiately 3 years

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



- Histologic confirmation of adenocarcinoma of the prostate and evidence of stage IV
disease

- Must have ECOG performance status 0-1

- Documented prostate cancer progression per PCWG3 criteria within 6 months prior to
screening

- Ongoing androgen deprivation therapy (ADT) with a gonadotropin-releasing hormone
(GnRH) analogue or bilateral orchiectomy

- Participants who are chemotherapy-naive and received 1 to 2 prior second generation
hormonal therapies

- Sufficient tumor sample from fresh or archival tumor tissue obtained no more than 1
year prior to enrollment, from a metastatic lesion or primary tumor lesion that has
not been previously irradiated
Minimum age
18 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
- Participants with active brain metastases

- Prior malignancy active within the previous 3 years except for locally curable cancers
that have been apparently cured

- Participants with an active, known, or suspected autoimmune disease

- Participants requiring systemic treatment with corticosteroids (> 10 mg daily
prednisone equivalent) or other immunosuppressive medications

- Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or any antibody
or drug specifically targeting T-cell co-stimulation or checkpoint pathways

- Prior treatment with docetaxel or another chemotherapy for metastatic castration
resistant prostate cancer

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,SA,VIC
Recruitment hospital [1] 0 0
Local Institution - Lismore
Recruitment hospital [2] 0 0
Local Institution - Wahroonga
Recruitment hospital [3] 0 0
Local Institution - Westmead
Recruitment hospital [4] 0 0
Local Institution - South Brisbane
Recruitment hospital [5] 0 0
Local Institution - Woolloongabba
Recruitment hospital [6] 0 0
Calvary North Adelaide Hospital - North Adelaide
Recruitment hospital [7] 0 0
Local Institution - Frankston
Recruitment hospital [8] 0 0
Local Institution - Malvern
Recruitment postcode(s) [1] 0 0
2480 - Lismore
Recruitment postcode(s) [2] 0 0
2076 - Wahroonga
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
4101 - South Brisbane
Recruitment postcode(s) [5] 0 0
4012 - Woolloongabba
Recruitment postcode(s) [6] 0 0
5006 - North Adelaide
Recruitment postcode(s) [7] 0 0
3199 - Frankston
Recruitment postcode(s) [8] 0 0
3144 - Malvern
Recruitment outside Australia
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Alabama
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Santa FE
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Cordoba
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Austria
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Linz
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Prague 2
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Manresa
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Sabadell (Barcelona)
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Niaosng
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Taichung
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Blackburn
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Guildford
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Lancaster
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Manchester
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Northwood
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Nottingham
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United Kingdom
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Southampton

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 test the safety and effectiveness of nivolumab with docetaxel
in men with advanced castration resistant prostate cancer who have progressed after
second-generation hormonal manipulation
Trial website
https://clinicaltrials.gov/show/NCT04100018
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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/show/NCT04100018