Phase 3 Study of Immunotherapy to Treat Advanced Prostate Cancer

The purpose of this study is to determine if patients with metastatic prostate cancer who have not received chemotherapy live longer when treated with ipilimumab than those treated with a placebo.

Official Title

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

Conditions

• Prostate cancer

Study Type

Interventional

Study Design

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study

Further Details

Primary Outcome Measures:

• 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
  [ Time Frame: Assessed at each study visit while on treatment and every 12 weeks during follow-up ]
  [ Designated as safety issue: No ]

Secondary Outcome Measures:

• Compare Progression Free Survival (PFS) by collecting tumor assessments every 12 weeks until protocol defined progression or initiation of subsequent therapy for prostate cancer
  [ Time Frame: each study visit while on treatment, and every 12 weeks during follow up until progression of disease or initiation of subsequent therapy for prostate cancer ]
  [ Designated as safety issue: No ]
• Compare time to pain progression by collection of a Patient Pain Diary prior to each treatment visit and every 12 weeks during follow up until progression of disease or initiation of subsequent therapy for prostate cancer
  [ Time Frame: each study visit while on treatment, and every 12 weeks during follow up until progression of disease or initiation of subsequent therapy for prostate cancer ]
  [ Designated as safety issue: No ]
• Compare time to subsequent non-hormonal systemic therapy by collection of subsequent prostate cancer therapies during follow up [ Time Frame: Every 12 weeks during follow up until initiation of subequent non-hormonal systemic therapy for prostate cancer ] [ Designated as safety issue: No ]
• Characterize Safety Profile by collection of adverse event information and review of laboratory values at every study visit [ Time Frame: Continuously throughout study and during follow up until all toxicities have resolved, returned to baseline or been deemed irreversible ]
  [ Designated as safety issue: Yes ]

Arms	Assigned Interventions
Ipilimumab: Experimental	Drug: Ipilimumab 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 Treatment Stopping Criteria are met, withdrawal of consent, or study closure.
Placebo: Placebo Comparator	Drug: Placebo 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 Treatment Stopping Criteria are met, withdrawal of consent, or study closure.

Study Start

June 2010 – October 2015

Eligibility & Criteria

• Ages Eligible for Study: 18 Years and older
• Genders Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Total Enrolment

600

Contact Details

Clinical.Trials@bms.com

Australia, New South Wales

• Local Institution, Kogarah, 2217

Australia, South Australia

• Local Institution, Ashford, 5035

Australia, Victoria

• Local Institution, Box Hill, 3128
• Local Institution, East Bentleigh, 3165
• Local Institution, Heidelberg, 3084

Australia, Western Australia

• Local Institution, Subiaco, 6008