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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

Phase 3
18 Years
Open (Enrolling)
Prostate Cancer

Thank you

Trial Information

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

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

Assessed at each study visit while on treatment and every 12 weeks during follow-up

Safety Issue:


Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb


United States: Food and Drug Administration

Study ID:




Start Date:

July 2010

Completion Date:

November 2015

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms



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