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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/NCT00861614
Registration number
NCT00861614
Ethics application status
Date submitted
12/03/2009
Date registered
13/03/2009
Date last updated
30/09/2016
Titles & IDs
Public title
Study of Immunotherapy to Treat Advanced Prostate Cancer
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Scientific title
A Randomized, Double-Blind, Phase 3 Trial Comparing Ipilimumab vs. Placebo Following Radiotherapy in Subjects With Castration Resistant Prostate Cancer That Have Received Prior Treatment With Docetaxel
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Secondary ID [1]
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2008-003314-97
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Secondary ID [2]
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CA184-043
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Universal Trial Number (UTN)
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Trial acronym
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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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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: Drugs - Ipilimumab
Treatment: Drugs - Placebo
Active Comparator: Ipilimumab -
Placebo Comparator: Placebo -
Treatment: Drugs: Ipilimumab
5 mg/ml solution, Intravenous, 10 mg/kg, Every 3 weeks for up to 4 doses in the Induction Phase. Every 12 weeks in the Maintenance Phase, Up to 24 weeks in Induction, 48+ weeks in the Maintenance Phase, or until Treatment Stopping Criteria are met, withdrawal of consent, lost to follow-up, death, study closure
Treatment: Drugs: Placebo
Solution, Intravenous, 0 mg, Every 3 weeks for up to 4 doses in the Induction Phase. Every 12 weeks in the Maintenance Phase, up to 24 weeks in Induction, 48+ weeks in the Maintenance Phase, or until Treatment Stopping Criteria are met, withdrawal of consent, lost to follow-up, death, study closure
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Intervention code [1]
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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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Overall Survival (OS)
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Assessment method [1]
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OS is defined as the time in months from randomization date to date of death due to any cause in all randomized subjects. For participants alive at the time of the database cutoff date, OS was censored at the last date the participant was known to be alive.
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Timepoint [1]
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Date of randomization to date of death
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Primary outcome [2]
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Overall Survival Rate
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Assessment method [2]
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The overall survival (OS) rate is a percentage, representing the fraction of all randomized participants who were alive following treatment, from 1 to 5 years. OS was defined as the time between the date of randomization and the date of death as a result of any cause. Survival rates were determined via Kaplan-Meier estimates.
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Timepoint [2]
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Date of randomization to date of death
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Secondary outcome [1]
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Progression Free Survival (PFS)
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Assessment method [1]
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All PFS events were based on investigator's assessment. Participants who were alive and did not experience a PFS event were censored at the earlier of the latest prostate-specific antigen (PSA) or radiological tumor assessment date. Participants who did not die, showed no clinical deterioration, and who had no recorded post-baseline PSA or radiological tumor assessment were censored at randomization date.
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Timepoint [1]
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Date of randomization to earliest date of confirmed PSA or radiological progression, clinical deterioration or death
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Secondary outcome [2]
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Pain Response
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Assessment method [2]
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The percentage of participants with a pain response assessed using the Brief Pain Inventory Short Form (BPI-SF) completed by participants throughout the study in a daily diary log. Pain-evaluable participants were defined as those with a decrease in the average daily worst pain intensity by at least 30% from baseline, maintained over 2 consecutive evaluations without the use of any rescue analgesic medication or increase in analgesic use in the same time period.
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Timepoint [2]
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Assessed at screening, weeks 12, 18, 24, and at the end of treatment visit
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Secondary outcome [3]
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Duration of Pain Response
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Assessment method [3]
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The time between the initial date of pain response and completion date of pain response. The initial date when the pain response criterion was achieved was considered the pain response date. The earlier of date of death, date of tumor resection surgery, or date when pain response criterion was no longer met was considered the completion date of the pain response. If none of these scenarios occurred, the completion of the pain response was set to the last known alive date.
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Timepoint [3]
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Day of initial pain response to day of completion of pain response or date of death
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Secondary outcome [4]
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Number of Participants With Severe Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs, Immune-Related Adverse Events (irAE) and Immune-Mediated Adverse Reaction (imAR)
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Assessment method [4]
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AE=any new unfavorable symptom, sign or disease or worsening of a preexisting condition that may not have a causal relationship with treatment.
SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity or drug dependency/abuse; is life-threatening, an important medical event or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible or missing relationship to study drug. Death=during study and up to 70 days after last dose. IrAEs=AEs potentially associated with inflammation and considered to be causally related to study drug and grouped into gastrointestinal (GI), hepatic, skin, endocrine and neurological. ImARs were collected prospectively and grouped into enterocolitis, hepatitis, dermatitis, neuropathies and endocrinopathies. IrAEs/ imARs were graded using Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE), Ver. 3.0.
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Timepoint [4]
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Randomization to date of death
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Secondary outcome [5]
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Time to Onset of Grade 3 or 4 Immune-Related Adverse Event (irAE)
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Assessment method [5]
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The time between first dose of study drug and date of earliest Grade 3 or 4 irAE. These irAEs are AEs of unknown etiology, consistent with an immune phenomenon and considered as causally related to drug exposure. The five subcategories of irAE examined include gastrointestinal (GI), liver, skin, endocrine, and neurological and are graded using the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
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Timepoint [5]
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Day 1 to 70 days after last dose of study drug
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Secondary outcome [6]
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Time to Resolution of Grade 3 or 4 Immune-Related Adverse Event (irAE)
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Assessment method [6]
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Time between the date of onset of a Grade 3 or 4 irAE and the date of improvement to Grade 1 or less or the worst grade at baseline.
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Timepoint [6]
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Day 1 to 70 days after last dose of study drug
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Secondary outcome [7]
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Time to Onset of Grade 3 to 5 Immune-Mediated Adverse Reaction (imAR)
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Assessment method [7]
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The time between first dose of study drug and date of earliest Grade 3 or 4 imAR. ImARs were collected prospectively and grouped into enterocolitis, hepatitis, dermatitis, neuropathies and endocrinopathies and graded using Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE), Ver. 3.0.
Only the Ipilimumab + Radiotherapy group of participants was included in the analysis because ipilimumab is associated with inflammatory events resulting from increased or excessive immune activity likely to be related to its mechanism of action.
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Timepoint [7]
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Day 1 to time of onset of the imAR of interest
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Secondary outcome [8]
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Time to Resolution of Grade 3 to 5 to Grade 0 Immune-Mediated Adverse Reactions (imARs) to Grade 0
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Assessment method [8]
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Time between the date of onset of an imAR to the date of resolution date of the event or the last known date participant was alive if an event did not resolve.
Only the Ipilimumab + Radiotherapy group of participants was included in the analysis because ipilimumab is associated with inflammatory events resulting from increased or excessive immune activity likely to be related to its mechanism of action.
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Timepoint [8]
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Day 1 to 70 days after last dose of study drug
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Secondary outcome [9]
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Number of Participants With Worst On-Study Hematology Common Toxicity Criteria (CTC) Grade and Shift From Baseline
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Assessment method [9]
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Comparison of baseline versus worst grade hematology laboratory tests as measured by white blood count (WBC), absolute neutrophil count (ANC), platelet count, hemoglobin and lymphocyte results. National Cancer Institute Common Terminology Criteria (CTC) version (v) 3.0 was used to determine Grade (Gr). Gr 0: within normal range. Abnormal values for WBC were based on Gr 1: 3.0 - < Lower Limit of Normal (LLN); Gr 2: 2.0 - < 3.0; Gr 3: 1.0 - < 2.0; Gr4: < 1.0. Abnormal values for Hemoglobin were based on Gr 1: 10.0 - < LLN; Gr 2: 8.0 - < 10.0; Gr 3: 6.5 - < 8.0; Gr 4: < 6.5. Abnormal values for Lymphocytes were based on Gr 1: 0.8 - < 1.5; Gr 2: 0.5 - < 0.8; Gr 3): 0.2 - < 0.5; Gr 4: < 0.2. Abnormal values for ANC were based on Gr 1: 1.5 - < 2.0; Gr 2: 1.0 - < 1.5; Gr 3: 0.5 - < 1.0; Gr 4: < 0.5. Abnormal values for Platelets were based on Gr 1: 75.0 - < LLN; Gr 2: 50.0 - < 75.0; Gr 3: 25.0 - < 50.0; Gr 4: < 25.0.
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Timepoint [9]
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Day 1 to 70 days after last dose of study drug
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Secondary outcome [10]
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Number of Participants With Worst On-Study Liver Common Toxicity Criteria (CTC) Grade and Shift From Baseline
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Assessment method [10]
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Comparison of baseline versus worst grade liver function as measured by alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin and alkaline phosphatase (ALP). National Cancer Institute Common Terminology Criteria (CTC) version (v) 3.0 was used to determine Grade (Gr). Gr 0: within normal range. Abnormal values for ALP, ALT and AST were based on grades; Gr 1: > 1.0 - 2.5 * upper limits of normal (ULN); Gr 2: > 2.5 - 5.0 * ULN; Gr 3: > 5.0 - 20.0 * ULN; Gr 4: > 20.0 * ULN. Abnormal values for Total Bilirubin were based on Gr 1: > 1.0 - 1.5 * upper limits of normal (ULN); Gr 2: > 1.5 - 3.0 * ULN; Gr 3: > 3.0 - 10.0 * ULN; Gr 4: > 10.0 * ULN.
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Timepoint [10]
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Day 1 to 70 days after last dose of study drug
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Secondary outcome [11]
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Number of Participants With Worst On-Study Serum Chemistry Common Toxicity Criteria (CTC) Grade and Shift From Baseline
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Assessment method [11]
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Comparison of baseline versus worst grade serum chemistry as measured by lipase and amylase analysis. National Cancer Institute Common Terminology Criteria (CTC) version (v) 3.0 was used to determine Grade (Gr). Gr 0: within normal range. Abnormal values for lipase: Gr1: > 1.0 - 1.5 * ULN; Gr2: > 1.5 - 2.0 * ULN; Gr 3: > 2.0 - 5.0 * ULN; Gr4: > 5.0*ULN. Abnormal values for amylase: Gr1: > 1.0 - 1.5 * ULN; Gr 2: > 1.5 - 2.0 * ULN; Gr 3: > 2.0 - 5.0 * ULN; Gr4: > 5.0 * ULN.
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Timepoint [11]
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Day 1 to 70 days after last dose of study drug
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Secondary outcome [12]
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Number of Participants With Worst On-Study Renal Function Common Toxicity Criteria (CTC) Grade and Shift From Baseline
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Assessment method [12]
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Comparison of baseline versus worst grade renal function as measured by creatinine analysis. National Cancer Institute Common Terminology Criteria (CTC) version (v) 3.0 was used to determine Grade (Gr).Gr 0: within normal range. Abnormal values for Creatinine were based on Gr 1: > 1.0 - 1.5*ULN; Gr 2: > 1.5 - 3.0*ULN; Gr 3: > 3.0 - 6.0*ULN; Gr 4: > 6.0*ULN.
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Timepoint [12]
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Day 1 to 70 days after last dose of study drug
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Eligibility
Key inclusion criteria
For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com.
- Advanced prostate cancer
- At least 1 bone metastasis
- Testosterone < 50 ng/dl
- Prior treatment with docetaxel
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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
- Brain metastasis
- Autoimmune disease
- Known HIV, Hep B, or Hep C infection
- More than 2 prior systemic anticancer regimens for prostate cancer
- Prior treatment on BMS CA180227 for prostate cancer
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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
1/05/2009
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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
1/08/2015
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Sample size
Target
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Accrual to date
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Final
988
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Recruitment in Australia
Recruitment state(s)
VIC,WA
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Recruitment hospital [1]
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Local Institution - Box Hill
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Recruitment hospital [2]
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Local Institution - Frankston
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Recruitment hospital [3]
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Local Institution - Heidelberg
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Recruitment hospital [4]
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Local Institution - Subiaco
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Recruitment postcode(s) [1]
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3128 - Box Hill
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Recruitment postcode(s) [2]
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3199 - Frankston
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Recruitment postcode(s) [3]
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3084 - Heidelberg
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Recruitment postcode(s) [4]
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6008 - Subiaco
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Recruitment outside Australia
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United States of America
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State/province [1]
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Alabama
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Alaska
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California
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Florida
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Georgia
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Illinois
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Kentucky
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Massachusetts
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West Virginia
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Tucuman
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La Rioja
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Odense C
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Bonn
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Haifa
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Tel Aviv
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Israel
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Tel Hashomer
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Italy
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Meldola (fc)
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Italy
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Milano
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Italy
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Napoli
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Italy
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Rimini
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Italy
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Siena
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Mexico
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Guerrero
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Jalisco
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Morelos
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Mexico
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Aguascalientes
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Mexico
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Puebla
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Country [87]
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Netherlands
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Amsterdam
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Country [88]
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Netherlands
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Mb Amsterdam
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Country [89]
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Peru
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Arequipa
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Country [90]
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Peru
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Lima
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Poland
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State/province [91]
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Olsztyn
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Puerto Rico
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Ponce
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Romania
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Bucharest
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Romania
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Romania
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Romania
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Suceava
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Russian Federation
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Moscow
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Russian Federation
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Obninsk
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Russian Federation
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St Petersburg
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Barcelona
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Spain
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Benidorm-alicante
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Spain
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Madrid
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Spain
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Santiago De Compostela
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Spain
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Valencia
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United Kingdom
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Essex
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United Kingdom
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Glamorgan
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United Kingdom
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Greater Manchester
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United Kingdom
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Lincolnshire
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United Kingdom
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Nottinghamshire
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Bristol-Myers Squibb
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Summary
Brief summary
The purpose of the study is to determine if advanced prostate cancer patients that are
treated with radiotherapy (RT) plus ipilimumab live longer that those treated with RT alone
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00861614
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Contacts
Principal investigator
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Bristol-Myers Squibb
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Bristol-Myers Squibb
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00861614
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