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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03338790
Registration number
NCT03338790
Ethics application status
Date submitted
8/11/2017
Date registered
9/11/2017
Date last updated
1/04/2024
Titles & IDs
Public title
An Investigational Immunotherapy Study of Nivolumab in Combination With Rucaparib, Docetaxel, or Enzalutamide in Metastatic Castration-resistant Prostate Cancer
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Scientific title
A Phase 2 Study of Nivolumab in Combination With Either Rucaparib, Docetaxel, or Enzalutamide in Men With Castration-resistant Metastatic Prostate Cancer
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Secondary ID [1]
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CA209-9KD
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Universal Trial Number (UTN)
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Trial acronym
CheckMate 9KD
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer
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Condition category
Condition code
Cancer
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Prostate
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - nivolumab
Treatment: Drugs - docetaxel
Treatment: Drugs - enzalutamide
Treatment: Drugs - rucaparib
Treatment: Drugs - prednisone
Experimental: nivolumab + rucaparib - Specified dose on specified days
Experimental: nivolumab + docetaxel + prednisone - Specified dose on specified days
Experimental: nivolumab + enzalutamide - Specified dose on specified days
Other interventions: nivolumab
Specified dose on specified days
Treatment: Drugs: docetaxel
Specified dose on specified days
Treatment: Drugs: enzalutamide
Specified dose on specified days
Treatment: Drugs: rucaparib
Specified dose on specified days
Treatment: Drugs: prednisone
Specified dose on specified days
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Intervention code [1]
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Other interventions
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Objective Response Rate Per Prostate Cancer Clinical Trials Working Group 3 (ORR-PCWG3)
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Assessment method [1]
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Objective response rate per prostate cancer clinical trials working group 3 (ORR-PCWG3) for target lesions and assessed by MRI is the percentage of participants who have a confirmed complete or partial best overall response (BOR) per PCWG3 among treated participants who have measurable disease
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Timepoint [1]
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Up to approximately 36 months
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Primary outcome [2]
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Prostate-Specific Antigen Response Rate (RR-PSA)
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Assessment method [2]
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Prostate-specific antigen response rate (RR-PSA) is the percentage of treated participants with a 50% or greater decrease in PSA from baseline to the lowest post-baseline PSA result
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Timepoint [2]
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Up to approximately 36 months
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Secondary outcome [1]
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Radiographic Progression-Free Survival (rPFS)
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Assessment method [1]
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Radiographic progress-free survival (rPFS) is the time between treatment initiation and the first date of documented progression or death due to any cause, whichever occurs first assessed by the investigator per PCWG3
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Timepoint [1]
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Up to approximately 36 months
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Secondary outcome [2]
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Time to Response Per Prostate Cancer Clinical Trials Working Group 3 (TTR-PCWG3)
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Assessment method [2]
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Time to response per prostate cancer clinical trials working group 3 (TTR-PCWG3) is the time from treatment initiation to the date of the first documented complete response (CR) or partial response (PR) per PCWG3
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Timepoint [2]
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Up to approximately 36 months
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Secondary outcome [3]
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Duration of Response Per Prostate Cancer Clinical Trials Working Group 3 (DOR-PCWG3)
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Assessment method [3]
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Duration of response per prostate cancer clinical trials working group 3 (DOR-PCWG3) is the time between the date of first response (complete response/partial response per PCWG3) to the date of first documented radiographic progression per PCWG3 or death due to any cause
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Timepoint [3]
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Up to approximately 36 months
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Secondary outcome [4]
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Prostate-Specific Antigen Time to Progression (TTP-PSA)
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Assessment method [4]
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Prostate-specific antigen time to progression (TTP-PSA) is the time between treatment initiation to the date of PSA progression per prostate cancer clinical trails working group 3
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Timepoint [4]
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Up to approximately 36 months
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Secondary outcome [5]
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Overall Survival (OS)
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Assessment method [5]
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Overall Survival (OS) is the time between treatment initiation and the date of death from any cause. For participants who are alive, their survival time will be censored at the last date that they were known to be alive. OS will be censored for participants at the date of treatment initiation if they had no follow-up
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Timepoint [5]
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Up to approximately 36 months
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Secondary outcome [6]
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Number of Participants With Adverse Events (AEs)
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Assessment method [6]
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Number of Participants with any grade adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, and immune-mediated AEs using the Common Toxicity Criteria Grade for Adverse Events (CTCAE V4)
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Timepoint [6]
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From first dose to up to 30 days post last dose (Up to 34 months)
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Secondary outcome [7]
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Number of Deaths
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Assessment method [7]
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Number of deaths in all treated participants
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Timepoint [7]
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Up to 36 months
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Secondary outcome [8]
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Number of Participants With Laboratory Abnormalities in Specific Liver Tests
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Assessment method [8]
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Number of participants with laboratory abnormalities in specific liver tests based on SI conventional units to assess the overall safety and tolerability of BMS-986213 in combination with chemotherapy vs. Nivolumab in combination with chemotherapy. The number of participants with the following laboratory abnormalities from on-treatment evaluations will be summarized:
ALT or AST > 3 x ULN, > 5 x ULN, > 10 x ULN and > 20 x ULN
Total bilirubin > 2 x ULN
ALP > 1.5 x ULN
Concurrent (within 1 day) ALT or AST > 3 x ULN and total bilirubin > 1.5 x ULN
Concurrent (within 30 days) ALT or AST > 3 x ULN and total bilirubin > 1.5 x ULN
Concurrent (within 1 day) ALT or AST > 3 x ULN and total bilirubin > 2 x ULN
Concurrent (within 30 days) ALT or AST > 3 x ULN and total bilirubin > 2 x ULN
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Timepoint [8]
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From first dose to up to 30 days post last dose (up to 34 months)
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Secondary outcome [9]
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Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
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Assessment method [9]
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Number of participants with laboratory abnormalities in specific thyroid tests based on US conventional units. The number of participants with the following laboratory abnormalities from on-treatment evaluations will be summarized:
TSH value > ULN and
with baseline TSH value <= ULN
with at least one FT3/FT4 test value < LLN within 2-week window after the abnormal TSH test
with all FT3/FT4 test values >= LLN within 2-week window after the abnormal TSH test
with FT3/FT4 missing within 2-week window after the abnormal TSH test.
TSH < LLN and
with baseline TSH value >= LLN
with at least one FT3/FT4 test value > ULN within 2-week window after the abnormal TSH test
with all FT3/FT4 test values <= ULN within 2-week window after the abnormal TSH test
with FT3/FT4 missing within 2-week window after the abnormal TSH test
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Timepoint [9]
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From first dose to up to 30 days post last dose (Up to 34 months)
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Secondary outcome [10]
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Number of Participants With Laboratory Values Change From Baseline
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Assessment method [10]
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Number of participants changed from baseline in laboratory values of worst toxicity grade (grade 0= wnl, grade 1= mild, grade 2= moderate, grade 3= severe) based on US conventional units by cohort
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Timepoint [10]
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From first dose to up to 30 days post last dose (Up to 34 months)
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Eligibility
Key inclusion criteria
- Histologic confirmation of adenocarcinoma of the prostate
- Evidence of stage IV disease on previous bone, CT, and/or MRI scan
- Ongoing androgen deprivation therapy (ADT) with a gonadotropin-releasing hormone
(GnRH) analogue or bilateral orchiectomy
- Mandatory plasma and fresh or archival tumor tissue must be submitted
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Prior malignancy active within the previous 3 years except for locally curable cancers
that have been apparently cured, such as basal or squamous cell skin cancer,
superficial bladder cancer, or carcinoma in situ of the breast
- Participants with active brain metastases
- Participants must have recovered from the effects of major surgery requiring general
anesthesia or significant traumatic injury at least 14 days before treatment arm
assignment
Other protocol defined inclusion/exclusion criteria could apply
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
19/12/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
15/09/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
292
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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Local Institution - 0015 - Camperdown
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Recruitment hospital [2]
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Local Institution - 0017 - Westmead
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Recruitment hospital [3]
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Local Institution - 0014 - South Brisbane
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Recruitment hospital [4]
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Local Institution - 0016 - Elizabeth Vale
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Recruitment hospital [5]
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Local Institution - 0050 - Clayton
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Recruitment hospital [6]
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Local Institution - 0013 - Heidelberg
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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2145 - Westmead
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Recruitment postcode(s) [3]
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4101 - South Brisbane
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Recruitment postcode(s) [4]
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5112 - Elizabeth Vale
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Recruitment postcode(s) [5]
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0 - Clayton
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Recruitment postcode(s) [6]
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3084 - Heidelberg
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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United States of America
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State/province [2]
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California
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United States of America
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Connecticut
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Kentucky
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United States of America
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Louisiana
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Maryland
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Massachusetts
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Michigan
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Mississippi
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Missouri
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Nebraska
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Argentina
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Buenos Aires
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Cordoba
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Argentina
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Distrito Federal
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Argentina
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Caba
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Rio de Janeiro
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Chile
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Medellin
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Besancon
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Clermont-ferrand
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France
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Lyon
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France
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Marseille
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France
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Villejuif
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Germany
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Essen
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Germany
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Goettingen
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Germany
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Heidelberg
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Germany
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Jena
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Germany
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Koblenz
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Germany
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Muenchen
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Mexico
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Guanajuato
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Mexico
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Jalisco
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Mexico
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Sinaloa
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Spain
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Madrid
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Spain
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Pamplona
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Spain
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Sevilla
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Bristol-Myers Squibb
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Address
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Clovis Oncology, Inc.
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Other collaborator category [2]
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Commercial sector/Industry
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Name [2]
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Astellas Pharma Inc
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Address [2]
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to assess the safety and efficacy of nivolumab in combination
with rucaparib, docetaxel, or enzalutamide in participants with castration-resistant prostate
cancer that has spread.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03338790
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Bristol-Myers Squibb
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Address
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Bristol-Myers Squibb
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Phone
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Email
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Contact person for public queries
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03338790
Download to PDF