Phase 3 Study of Immunotherapy to Treat Advanced Prostate Cancer

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Prostate Cancer

Treatments: Drug: Placebo; Drug: Ipilimumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01057810

2009-016217-23 (EudraCT Number)

CA184-095

Details and patient eligibility

About

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

Enrollment: 837 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:

• Metastatic prostate cancer
• Asymptomatic or minimally symptomatic
• Progression during hormonal therapy
• Eastern Cooperative Oncology Group (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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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837 participants in 2 patient groups, including a placebo group

Ipilimumab

Experimental group

Treatment:

Drug: Ipilimumab

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo