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:	NCT00861614

Purpose

The purpose of the study is to determine if advanced prostate cancer patient s that are treated with radiotherapy (RT) plus ipilimumab live longer that those treated with RT alone

Condition	Intervention	Phase
Prostate Cancer	Drug: Ipilimumab Drug: Placebo	Phase 3

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

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:

Overall survival [ Time Frame: is assessed at each study visit while on treatment and every 12 weeks in the post-treatment Follow-up Phase ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Compare progression free survival (PFS) [ Time Frame: Assessed at each study visit while on treatment and every 12 weeks in the post-treatment Follow-up Phase until alternative treatment is initiated ] [ Designated as safety issue: No ]
Compare pain response [ Time Frame: Assessed at screening, weeks 12, 18, 24, and at the End of Treatment visit ] [ Designated as safety issue: No ]
Characterize safety profile [ Time Frame: Assessed at each study visit while on treatment and for 70 days following the last dose of study drug ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	800
Study Start Date:	May 2009
Estimated Study Completion Date:	June 2013
Estimated Primary Completion Date:	January 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 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 Induction, 48+ weeks in the Maintenance Phase, or until Treatment Stopping Criteria are met, withdrawal of consent, lost to follow-up, death, study closure Other Name: BMS 734016
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 Induction, 48+ weeks in the Maintenance Phase, or until Treatment Stopping Criteria are met, withdrawal of consent, lost to follow-up, death, study closure

Eligibility

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

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00861614

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 168 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:	NCT00861614 History of Changes
Other Study ID Numbers:	CA184-043, 2008-003314-97
Study First Received:	March 12, 2009
Last Updated:	April 30, 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 May 23, 2012