Phase 3 Study of Immunotherapy to Treat Advanced Prostate Cancer - Full Text View

Sponsor:	Bristol-Myers Squibb
Information provided by (Responsible Party):	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT01057810

Purpose

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

Condition	Intervention	Phase
Prostate Cancer	Drug: Ipilimumab Drug: Placebo	Phase III

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Ipilimumab

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

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 ]

Estimated Enrollment:	600
Study Start Date:	July 2010
Estimated Study Completion Date:	November 2015
Estimated Primary Completion Date:	January 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Ipilimumab	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 Other Names: BMS-734016 MDX010
Placebo Comparator: Placebo	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

Eligibility

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

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01057810

Contacts

Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email:		Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

Show 156 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

Investigator Inquiry form This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

No publications provided by Bristol-Myers Squibb

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Dayyani F, Gallick GE, Logothetis CJ, Corn PG. Novel therapies for metastatic castrate-resistant prostate cancer. J Natl Cancer Inst. 2011 Nov 16;103(22):1665-75. Epub 2011 Sep 13.

Responsible Party:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT01057810 History of Changes
Other Study ID Numbers:	CA184-095, 2009-016217-23
Study First Received:	January 26, 2010
Last Updated:	February 2, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site

Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on February 09, 2012