Phase 3 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 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
• 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 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

Study Details

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

Key Dates

Start date

Jul 31, 2010

Status verified

Jul 2016

Primary completion

Apr 30, 2015

Completion

Jul 31, 2015

Study Design

Enrollment

837 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Ipilimumab
• Placebo Comparator: Placebo

Primary Outcome Measure

Overall Survival (OS) Time [ Time Frame: Randomization until death from any cause, up to April 2015, approximately 57 months ]

Locations (42)

Find similar trials in Anchorage, AK

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