Study of Immunotherapy to Treat Advanced Prostate Cancer

Conditions

• Prostate Cancer

Eligibility Criteria

Sex

MALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Ipilimumab — DRUG
  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
• Placebo — DRUG
  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

Study Details

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

Key Dates

Start date

May 31, 2009

Status verified

Aug 2016

Primary completion

Nov 30, 2012

Completion

Aug 31, 2015

Study Design

Enrollment

988 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Ipilimumab
• Placebo Comparator: Placebo

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: Date of randomization to date of death ]

Locations (44)

Find similar trials in Mobile, AL

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