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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01057810
Registration number
NCT01057810
Ethics application status
Date submitted
26/01/2010
Date registered
27/01/2010
Date last updated
18/08/2016
Titles & IDs
Public title
Phase 3 Study of Immunotherapy to Treat Advanced Prostate Cancer
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Scientific title
Randomized, Double-Blind, Phase 3 Trial to Compare the Efficacy of Ipilimumab vs Placebo in Asymptomatic or Minimally Symptomatic Patients With Metastatic Chemotherapy-Naïve Castration Resistant Prostate Cancer
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Secondary ID [1]
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2009-016217-23
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Secondary ID [2]
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CA184-095
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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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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
Experimental: 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 the Induction Phase. Treatment in the Maintenance Phase continues until total treatment period has reached three years,Treatment Stopping Criteria are met, withdrawal of consent, or 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 the Induction Phase. Treatment in the Maintenance Phase continues until total treatment period has reached three years,Treatment Stopping Criteria are met, withdrawal of consent, or 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) Time
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Assessment method [1]
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OS was defined as the time from the date of randomization until the date of death. For participants without documentation of death, OS was censored at the last date the participant was known to be alive.
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Timepoint [1]
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Randomization until death from any cause, up to April 2015, approximately 57 months
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Secondary outcome [1]
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Progression-Free Survival (PFS) Time
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Assessment method [1]
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Progression-free survival, as determined by the investigator, was defined as the time from randomization to the earliest date of confirmed Prostate-Specific Antigen (PSA) progression, confirmed radiological progression, clinical deterioration, or death.
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Timepoint [1]
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Randomization until disease progression, up to April 2015, approximately 57 months
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Secondary outcome [2]
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Time to Subsequent Non-hormonal Cytotoxic Therapy
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Assessment method [2]
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For participants who discontinued treatment or experienced disease progression while on study therapy and then received subsequent non-hormonal cytotoxic therapy, time to subsequent non-hormonal cytotoxic therapy was defined as the time from randomization to the time of initiation of subsequent non-hormonal cytotoxic therapy. Participants who did not receive subsequent non-hormonal cytotoxic therapy were censored on the last known alive date (for participants who have not died) or the date of last follow-up contact at which the participants was known alive (for participants who died).
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Timepoint [2]
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Randomization until subsequent non-hormonal cytotoxic therapy, up to April 2015, approximately 57 months
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Secondary outcome [3]
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Time to Pain Progression
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Assessment method [3]
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Time to pain progression was defined as the time from randomization to the time of the earliest date of any of the following 4 events: 1) an increase in average daily worst pain intensity of \>= 2 points from baseline according to the Brief Pain Inventory - Short Form (BPI-SF), maintained over 2 consecutive time periods. 2) initiation of opioid analgesic (excluding codeine or dextropropoxyphene). 3) initiation of palliative radiotherapy for prostate cancer. 4) increase in mean Analgesic Score (AS) of \>= 25% from baseline (for participants with baseline AS \> 10) or increase in mean AS \>= 10 points from baseline (for participants with baseline AS \<= 10).
Participants who did not experience any of these events were censored on the earliest date among the latest BPI-SF completion date with non-missing worst pain assessment and last evaluable disease assessment date as defined in the PFS censoring mechanism.
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Timepoint [3]
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Randomization until pain progression, up to April 2015, approximately 57 months
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Secondary outcome [4]
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Number of Participants Who Died or Had Adverse Events (AEs), Serious Adverse Events (SAEs), Immune-related AEs (irAEs), or Immune-mediated Adverse Reactions (imARs)
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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. irAE=AEs consistent with an immune mediated mechanism. imAR=AEs of special interest that were adjudicated as imAR by investigator. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. Events were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
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Timepoint [4]
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Day 1 of study therapy to last dose plus 70 days
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Secondary outcome [5]
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Number of Treated Participants With Grade 3 or 4 Clinical Laboratory Abnormalities
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Assessment method [5]
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NCI CTC, Version 3 used to assess parameters. LLN=lower limit of normal. ULN=upper limit of normal. CTC criteria:
White blood cells (WBC): Gr 3:\<2.0 to 1.0\*10\^9/L, Gr 4:\<1.0\*10\^9/L. Absolute neutrophil count (ANC): Gr 3:\<1.0 to 0.5\*10\^9/L, Gr 4:\<0.5\*10\^9/L.
Platelet count: Gr 3:\<50.0 to 25.0\*10\^9/L, Gr 4:\<25.0 to 10\^9/L. Hemoglobin: Gr 3:\<8.0 to 6.5 g/dL, Gr 4:\<6.5 g/dL. Absolute Lymphocyte Count (ALC): Gr 3: 0.2 - \<0.5\*10\^9/L, Gr 4: \<0.2\*10\^9/L.
Lipase: Gr 3:\> 2.0 - 5.0 \* ULN; Gr 4: \> 5.0 X ULN. Amylase: Gr 3: \> 2.0 - 5.0 \* ULN; Gr 4: \> 5.0 \* ULN. Alanine Aminotransferase (ALT) Gr 3: \> 5.0 - 20.0 \* ULN; Gr 4: \> 20.0 \* ULN. Aspartate Aminotransferase (AST): Gr 3: \> 5.0 - 20.0 \* ULN; Gr 4: \> 20.0 \* ULN. Bilirubin: Gr 3: \> 3.0 - 10.0 \* ULN; Gr 4: \> 10.0 \* ULN. Alkaline Phosphatase: Gr 3: \> 5.0 - 20.0 \* ULN; Gr 4: \> 20.0 \* ULN. Creatinine: Gr 3: \> 3.0-6.0 \* ULN, Gr 4: \>6.0 \* ULN.
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Timepoint [5]
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Randomization up to April 2015, approximately 57 months
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Eligibility
Key inclusion criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
* Metastatic prostate cancer
* Asymptomatic or minimally symptomatic
* Progression during hormonal therapy
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
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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
* Liver, lung or brain metastases
* Prior immunotherapy or chemotherapy for metastatic prostate cancer
* Autoimmune disease
* HIV, Hepatitis B, or Hepatitis C infection
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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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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
1/07/2010
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Date of last participant enrolment
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Actual
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Date of last data collection
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Actual
1/07/2015
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Sample size
Target
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Accrual to date
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Final
837
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
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Recruitment hospital [1]
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Local Institution - Kogarah
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2217 - Kogarah
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5035 - Ashford
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3128 - Box Hill
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3165 - East Bentleigh
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3199 - Frankston
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3084 - Heidelberg
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6008 - Subiaco
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Recruitment outside Australia
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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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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to determine if asymptomatic or minimally symptomatic patients with metastatic prostate cancer who have not received chemotherapy live longer when treated with ipilimumab than those treated with a placebo
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Trial website
https://clinicaltrials.gov/study/NCT01057810
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Trial related presentations / publications
de Liano AG, Reig O, Mellado B, Martin C, Rull EU, Maroto JP. Prognostic and predictive value of plasma testosterone levels in patients receiving first-line chemotherapy for metastatic castrate-resistant prostate cancer. Br J Cancer. 2014 Apr 29;110(9):2201-8. doi: 10.1038/bjc.2014.189. Epub 2014 Apr 10. Dayyani F, Gallick GE, Logothetis CJ, Corn PG. Novel therapies for metastatic castrate-resistant prostate cancer. J Natl Cancer Inst. 2011 Nov 16;103(22):1665-75. doi: 10.1093/jnci/djr362. Epub 2011 Sep 13.
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Public notes
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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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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
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Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01057810
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