Study of Immunotherapy to Treat Advanced Prostate Cancer

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Prostate Cancer

Treatments: Drug: Ipilimumab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00861614

CA184-043

2008-003314-97

Details and patient eligibility

About

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

Enrollment: 988 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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988 participants in 2 patient groups, including a placebo group

Ipilimumab

Active Comparator group

Treatment:

Drug: Ipilimumab

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo