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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

REBEC

Registry ID

RBR-5qcvv9

Enrollment

Unknown

Registered

2011-11-13

Start date

2010-07-28

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Chemotherapy-Naïve Castration Resistant Prostate Cancer

Interventions

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. Tre

drug

biological/vaccine

SP4.026.292.663

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Metastatic prostate cancer. Asymptomatic or minimally symptomatic. Progression during hormonal therapy. ECOG Performance Status 0-1

Exclusion criteria

Exclusion criteria: Liver, lung or brain metastases. Prior immunotherapy or chemotherapy for metastatic prostate cancer. Autoimmune disease. HIV, Hepatitis B, or Hepatitis C infection

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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]	—

Measure

Time frame

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]

—

Countries

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

Public ContactGlaucia Silva

Bristol-Myers Squibb

glaucia.silva@bms.com+55(11)3882-2165

Outcome results

None listed

Source: REBEC (via WHO ICTRP)