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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04100018
Registration number
NCT04100018
Ethics application status
Date submitted
20/09/2019
Date registered
23/09/2019
Date last updated
22/07/2024
Titles & IDs
Public title
A Study of Nivolumab or Placebo in Combination With Docetaxel in Men With Advanced Castration-resistant Prostate Cancer
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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
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Secondary ID [1]
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2019-002030-36
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Secondary ID [2]
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CA209-7DX
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Universal Trial Number (UTN)
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Trial acronym
CheckMate 7DX
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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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0
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Condition category
Condition code
Cancer
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0
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Prostate
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - Nivolumab
Treatment: Drugs - Prednisone
Treatment: Drugs - Docetaxel
Other interventions - Placebo
Experimental: Arm A: Nivolumab + docetaxel + prednisone -
Placebo comparator: Arm B: Placebo + docetaxel + prednisone -
Treatment: Other: Nivolumab
Specified dose on specified days
Treatment: Drugs: Prednisone
Specified dose on specified days
Treatment: Drugs: Docetaxel
Specified dose on specified days
Other interventions: Placebo
Specified dose on specified days
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Intervention code [1]
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Treatment: Other
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Intervention code [2]
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Treatment: Drugs
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Intervention code [3]
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Other interventions
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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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Radiographic Progressive Free Survival (rPFS) Assessed by Blinded Independent Central Review (BICR) Per Prostate Cancer Working Group 3 (PCWG3)
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Assessment method [1]
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rPFS for randomized participants is the time between randomization and the first date of documented progression or death due to any cause, whichever occurs first. The rPFS was censored at the last radiographic tumor assessment up to the start of subsequent cancer therapy for those without progression or death. It was also censored at the date of last radiographic tumor assessment prior to the missed tumor assessments for participants who had progressive disease (PD) or death immediately after more than one consecutive missed tumor assessments. Radiographic progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). The appearance of one or more new lesions is also considered progression.
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Timepoint [1]
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from randomization to the first date of documented progression or death due to any cause, whichever occurs first (up to approximately 31 months)
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Primary outcome [2]
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Overall Survival (OS)
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Assessment method [2]
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OS for all randomized participants is the time between randomization and the date of death from any cause. For participants who are alive, their survival time was censored at the last date that they were known to be alive. OS was censored for participants at the date of randomization if they had no follow-up.
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Timepoint [2]
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From randomization to the date of death from any cause (Up to approximately 31 months)
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Secondary outcome [1]
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Objective Response Rate (ORR) Assessed by Blinded Independent Central Review (BICR) Per Prostate Cancer Working Group (PCWG3)
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Assessment method [1]
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Objective Response Rate per PCWG3 (ORR-PCWG3) is the percentage of participants who have a confirmed complete or partial best overall response (BOR) per PCWG3 among randomized participants who have measurable disease at baseline. Complete Response (CR) is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR) is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Baseline was defined as evaluations or events that occur before the date and time of the first dose of study treatment or evaluations on the same date and time of the first dose of study treatment were also considered as baseline evaluations.
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Timepoint [1]
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From date of randomization to the date of objectively documented progression per PCWG3 or the date of subsequent systemic cancer therapy, whichever occurs first (Up to approximately 31 months)
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Secondary outcome [2]
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Time to Response (TTR) Assessed by Blinded Independent Central Review (BICR) Per Prostate Cancer Working Group (PCWG3)
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Assessment method [2]
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Time to Response per PCWG3 (TTR-PCWG3) is the time from randomization to the date of the first documented CR or PR per PCWG3, as determined by BICR. Complete Response (CR) is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR) is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
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Timepoint [2]
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From randomization to the date of the first documented CR or PR (Up to approximately 31 months)
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Secondary outcome [3]
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Duration of Response Assessed by Blinded Independent Central Review (BICR) Per Prostate Cancer Working Group (PCWG3)
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Assessment method [3]
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Duration of Response per PCWG3 (DOR-PCWG3) is time between the date of first response (CR/PR per PCWG3) to the date of first documented radiographic progression per PCWG3,as determined by BICR, or death due to any cause whichever occurs first. Complete Response (CR) is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR) is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Radiographic progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). The appearance of one or more new lesions is also considered progression.
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Timepoint [3]
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From randomization date to the date of first documented radiographic progression or death due to any cause whichever occurs first (Up to approximately 31 months)
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Secondary outcome [4]
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Prostate-specific Antigen (PSA) Response Rate (PSA-RR)
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Assessment method [4]
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PSA Response Rate (PSA-RR) is the percentage of randomized participants with a 50% or greater decrease in PSA from baseline to the lowest post-baseline PSA result. A second consecutive value obtained 3 or more weeks later is required to confirm the PSA response. Baseline was defined as valuations or events that occur before the date and time of the first dose of study treatment or evaluations on the same date and time of the first dose of study treatment were also considered as baseline evaluations.
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Timepoint [4]
0
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Up to approximately 31 months
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Secondary outcome [5]
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Time to PSA Progression (TTP-PSA)
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Assessment method [5]
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Time to PSA Progression (TTP-PSA) is the time between randomization to the date of PSA progression per PCWG3 in randomized participants. PSA Progression: For participants with an initial PSA decline from baseline, the date of PSA progression is the date that an increase of 25% or more and an absolute increase of 2 ng/mL or more from the nadir are documented and confirmed by a second consecutive PSA value at least 3 weeks later. For participants with no PSA decline from baseline, the date of PSA progression is date that an increase of 25% or more and an absolute increase of 2 ng/mL or more from baseline are documented at or beyond Week 13. Baseline was defined as valuations or events that occur before the date and time of the first dose of study treatment or evaluations on the same date and time of the first dose of study treatment were also considered as baseline evaluations. Censored at date of last PSA evaluation on/prior to start of subsequent cancer therapy.
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Timepoint [5]
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from randomization to the date of PSA Progression (Up to approximately 31 months)
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Secondary outcome [6]
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Number of Participants With Adverse Events
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Assessment method [6]
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An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.
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Timepoint [6]
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From first dose and 30 days after last dose of study therapy (Up to approximately 11 months)
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Secondary outcome [7]
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Number of Participants With Serious Adverse Events
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Assessment method [7]
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Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death or Is life-threatening or requires inpatient hospitalization or causes prolongation of existing hospitalization or results in persistent or significant disability/incapacity or is a congenital anomaly/birth defect.
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Timepoint [7]
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From first dose and 30 days after last dose of study therapy (Up to approximately 11 months)
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Secondary outcome [8]
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Number of Participants With Adverse Events Leading to Discontinuation
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Assessment method [8]
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An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.
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Timepoint [8]
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From first dose and 30 days after last dose of study therapy (Up to approximately 11 months)
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Secondary outcome [9]
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Number of Participants With Endocrine Immune-Mediated Adverse Events
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Assessment method [9]
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Immune-mediated adverse events are AEs consistent with an immune-mediated mechanism or immune-mediated component for which non-inflammatory etiologies (eg, infection or tumor progression) have been ruled out. IMAEs can include events with an alternate etiology which were exacerbated by the induction of autoimmunity. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.
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Timepoint [9]
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From first dose and 100 days after last dose of study therapy (Up to approximately 13 months)
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Secondary outcome [10]
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Number of Participants With Non-Endocrine Immune-Mediated Adverse Events
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Assessment method [10]
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Immune-mediated adverse events are AEs consistent with an immune-mediated mechanism or immune-mediated component for which non-inflammatory etiologies (eg, infection or tumor progression) have been ruled out. IMAEs can include events with an alternate etiology which were exacerbated by the induction of autoimmunity. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.
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Timepoint [10]
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From first dose and 100 days after last dose of study therapy (Up to approximately 13 months)
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Secondary outcome [11]
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Number of Participants With Select Adverse Events
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Assessment method [11]
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An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.
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Timepoint [11]
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0
From first dose and 30 days after last dose of study therapy (Up to approximately 11 months)
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Secondary outcome [12]
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Number of Participants Who Died
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Assessment method [12]
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0
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Timepoint [12]
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Up to approximately 31 months
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Secondary outcome [13]
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Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Results
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Assessment method [13]
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The severity of laboratory test results were graded based upon the participants symptoms according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0); Hematology parameters were evaluated for severity according to the following scale: Grade 0 is defined as absence of an AE or within normal limits; Grade 1 = Mild - transient or mild discomfort; no medical intervention required; Grade 2 = Moderate - mild to moderate limitation in activity; Grade 3 = Severe; Grade 4 = Life threatening. Number of participants with worst grade laboratory test results is presented.
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Timepoint [13]
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From first dose and 30 days after last dose of study therapy (Up to approximately 11 months)
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Secondary outcome [14]
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Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
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Assessment method [14]
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Blood samples were collected for conducting specific thyroid test. Baseline is defined as evaluations or events that occur before the date and time of the first dose of study treatment. Baseline was defined as evaluations or events that occur before the date and time of the first dose of study treatment or evaluations on the same date and time of the first dose of study treatment were also considered as baseline evaluations.
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Timepoint [14]
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From first dose and 30 days after last dose of study therapy (Up to approximately 11 months)
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Secondary outcome [15]
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Time to Pain Progression as Assessed by Brief Pain Inventory-Short Form (BPI-SF)
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Assessment method [15]
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The BPI-SF is an instrument to assess pain and includes severity and interference scores. BPI-SF is an 11-item self-report questionnaire designed to assess severity and impact of pain on daily function. Participants rate severity of pain at its "worst," "least," and "average" in last 24 hours using an 11-point numerical rating scale with anchors of "no pain" and "pain as bad. The participant's assessment of pain with BPI-SF Item number 3 (pain symptoms at their worst over the last 24 hours) form basis for analysis. Time to pain progression is time between date of randomization and date of first increase in worst pain intensity. Pain progression occurred if an increase in worst pain intensity of \>= 2 points is observed from baseline and maintained over 2 consecutive time periods. Baseline was evaluations or events that occur before date and time of first dose of study treatment or evaluations on same date and time of first dose of study treatment were also considered as baseline.
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Timepoint [15]
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From randomization to 1st pain symptoms at their worst over the last 24 hours (Up to approximately 31 months
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Eligibility
Key inclusion criteria
* Histologic confirmation of adenocarcinoma of the prostate without small cell features
* Current evidence of metastatic disease documented by either bone lesions on radionuclide bone scan and/or soft tissue lesions on computerized tomography/magnetic resonance imaging (CT/MRI)
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Ongoing androgen deprivation therapy (ADT) with a gonadotropin-releasing hormone (GnRH) analogue or bilateral orchiectomy
* Documented prostate cancer progression per Prostate Cancer Working Group (PCWG3) criteria within 6 months prior to screening
* Chemotherapy-naïve for metastatic castration-resistant prostate cancer (mCRPC), with 1 to 2 prior second generation hormonal therapies in the recurrent non-metastatic setting and/or metastatic setting, and no more than 1 second generation hormonal therapy in the mCRPC setting. Must have progressed during or after second generation hormonal therapy or have documented intolerance to second generation hormonal therapy
* Participants must meet one of the following criteria regarding tissue submission: Sufficient tumor samples from a newly obtained ("fresh") biopsy (obtained during screening); or archival tumor tissue in the form of formalin-fixed paraffin-embedded (FFPE) block or unstained tumor tissue slides. For participants with bone-only disease or inaccessible soft tissue lesions or if the biopsy procedure would pose an unacceptable clinical risk for the participant, submission of tumor tissue obtained from a fresh biopsy is not required.
* Men must agree to follow specific methods of contraception, if applicable
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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
* Active brain metastases
* Active, known, or suspected autoimmune disease
* Condition requiring systemic treatment with corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of study treatment. Inhaled or topical steroids or adrenal replacement steroid doses are permitted in the absence of active autoimmune disease
* Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
* Prior treatment with docetaxel or other chemotherapy for mCRPC. Prior docetaxel for metastatic castration-sensitive prostate cancer is permitted if at least 12 months have elapsed from last dose of docetaxel
Other protocol-defined inclusion/exclusion criteria apply
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled 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
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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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
6/02/2020
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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
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Actual
25/06/2024
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Sample size
Target
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Accrual to date
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Final
1030
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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 - 0152 - Gosford
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Recruitment hospital [2]
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Local Institution - 0091 - Lismore
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Recruitment hospital [3]
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Local Institution - 0132 - Wahroonga
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Local Institution - 0127 - Westmead
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Recruitment hospital [5]
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Local Institution - 0006 - South Brisbane
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Recruitment hospital [6]
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Local Institution - 0084 - Woolloongabba
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Recruitment hospital [7]
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Local Institution - 0010 - North Adelaide
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Recruitment hospital [8]
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Local Institution - 0379 - Ballarat
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Recruitment hospital [9]
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Local Institution - 0040 - Frankston
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Recruitment hospital [10]
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Local Institution - 0032 - Malvern
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Recruitment postcode(s) [1]
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2250 - Gosford
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Recruitment postcode(s) [2]
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2480 - Lismore
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Recruitment postcode(s) [3]
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2076 - Wahroonga
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Recruitment postcode(s) [4]
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2145 - Westmead
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Recruitment postcode(s) [5]
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4101 - South Brisbane
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Recruitment postcode(s) [6]
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4102 - Woolloongabba
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Recruitment postcode(s) [7]
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5006 - North Adelaide
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Recruitment postcode(s) [8]
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3350 - Ballarat
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Recruitment postcode(s) [9]
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3199 - Frankston
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Recruitment postcode(s) [10]
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3144 - Malvern
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Recruitment outside Australia
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Alabama
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Alaska
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RS
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Brazil
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SAO Paulo
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SP
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Chile
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Israel
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Israel
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Ramat Gan
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Israel
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Tel Aviv
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Taichung
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Adana
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Malatya
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United Kingdom
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Greater London
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Surrey
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United Kingdom
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London
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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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Country
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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 effectiveness of nivolumab with docetaxel in men with advanced castration resistant prostate cancer who have progressed after second-generation hormonal manipulation.
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Trial website
https://clinicaltrials.gov/study/NCT04100018
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
Bristol-Myers Squibb
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Address
0
0
Bristol-Myers Squibb
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Country
0
0
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Phone
0
0
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Fax
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0
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Email
0
0
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Contact person for public queries
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0
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Address
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0
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Country
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0
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Phone
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/18/NCT04100018/Prot_SAP_000.pdf
Statistical analysis plan
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/18/NCT04100018/Prot_SAP_000.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04100018
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