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A Randomized, Double-Blind, Phase 3 Trial Comparing Ipilimumab vs. Placebo Following Radiotherapy in Subjects With Castration Resistant Prostate Cancer That Have Received Prior Treatment With Docetaxel

Phase 3
18 Years
Open (Enrolling)
Prostate Cancer

Thank you

Trial Information

A Randomized, Double-Blind, Phase 3 Trial Comparing Ipilimumab vs. Placebo Following Radiotherapy in Subjects With Castration Resistant Prostate Cancer That Have Received Prior Treatment With Docetaxel

For additional information, please contact the BMS oncology clinical trial information
service at 855-216-0126 or email Please visit for more information on clinical trial participation.

Inclusion Criteria:

- Advanced prostate cancer

- At least 1 bone metastasis

- Testosterone < 50 ng/dl

- Prior treatment with docetaxel

Exclusion Criteria:

- Brain metastasis

- Autoimmune disease

- Known HIV, Hep B, or Hep C infection

- More than 2 prior systemic anticancer regimens for prostate cancer

- Prior treatment on BMS CA180227 for prostate cancer

Type of Study:


Study Design:

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

Outcome Measure:

Overall survival

Outcome Time Frame:

is assessed at each study visit while on treatment and every 12 weeks in the post-treatment Follow-up Phase

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:

May 2009

Completion Date:

February 2017

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms



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