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

• Register: REBEC
• Last refreshed on: 29 April 2013
• Main ID: RBR-5qcvv9
• Date of registration: 13/11/2011
• Primary sponsor: Bristol-Myers Squibb - Brazil
• Public 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
• 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 - Not applicable : Not applicable
• Date of first enrolment: 28/07/2010
• Target sample size: 600
• Recruitment status: recruitment completed
• URL: http://www.ensaiosclinicos.gov.br/rg/RBR-5qcvv9/
• Study design: Therapeutic, parallel, 2 arms , double-blind, randomized, multicenter, Phase 3 clinical trial

Countries of recruitment

Argentina, Australia, Brazil, Canada, Chile, Colombia, Czech Republic, Denmark, France, Germany, Greece, Hungary, Italy, Mexico, Netherlands, Peru, Poland, Puerto Rico, Romania, Spain, Sweden, Turkey, United Kingdom, United States

Contacts

• Name: Glaucia Silva
• Affiliation: Bristol-Myers Squibb

• Name: Glaucia Silva
• Affiliation: Bristol-Myers Squibb

Key inclusion & exclusion criteria

Inclusion criteria: Metastatic prostate cancer. Asymptomatic or minimally symptomatic. Progression during hormonal therapy. ECOG Performance Status 0-1
Exclusion criteria: Liver, lung or brain metastases. Prior immunotherapy or chemotherapy for metastatic prostate cancer. Autoimmune disease. HIV, Hepatitis B, or Hepatitis C infection

Age minimum: 18Y
Age maximum: 0
Gender: M

Health Condition(s) or Problem(s) studied

Metastatic Chemotherapy-Naïve Castration Resistant Prostate Cancer
C61

Intervention(s)

Arm A: 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 Treatment Stopping Criteria are met, withdrawal of consent, or study closure. Arm B: 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 Treatment Stopping Criteria are met, withdrawal of consent, or study closure

Primary Outcome(s)

To compare overall survival (OS) of subjects, defined as the time from the date of randomization until the date of death. For those subjects who have not died OS will be censored at the last date the subject was known to be alive. Assessed at each study visit while on treatment and every 12 weeks during follow-up

Secondary Outcome(s)

Compare Progression Free Survival (PFS) by collecting tumor assessments every 12 weeks until protocol defined progression or initiation of subsequent therapy for prostate cancer [Time Frame: each study visit while on treatment, and every 12 weeks during follow up until progression of disease or initiation of subsequent therapy for prostate cancer]. Compare time to pain progression by collection of a Patient Pain Diary prior to each treatment visit and every 12 weeks during follow up until progression of disease or initiation of subsequent therapy for prostate cancer [Time Frame: each study visit while on treatment, and every 12 weeks during follow up until progression of disease or initiation of subsequent therapy for prostate cancer]. Compare time to subsequent non-hormonal systemic therapy by collection of subsequent prostate cancer therapies during follow up [Time Frame: Every 12 weeks during follow up until initiation of subequent non-hormonal systemic therapy for prostate cancer]. Characterize Safety Profile by collection of adverse event information and review of laboratory values at every study visit [Time Frame: Continuously throughout study and during follow up until all toxicities have resolved, returned to baseline or been deemed irreversible]

Secondary ID(s)

21/2011

473/2010

Source(s) of Monetary Support

Bristol-Myers Squibb - Brazil

Secondary Sponsor(s)

Bristol-Myers Squibb - Brazil