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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


Phase 3
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

Thank you

Trial Information

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


For additional information, please contact the BMS oncology clinical trial information
service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit
www.BMSStudyConnect.com for more information on clinical trial participation.

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

Type of Study:

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

Outcome Measure:

Overall survival

Outcome Time Frame:

is assessed at each study visit while on treatment and every 12 weeks in the post-treatment Follow-up Phase

Safety Issue:

No

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA184-043

NCT ID:

NCT00861614

Start Date:

May 2009

Completion Date:

February 2017

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021
Mayo ClinicRochester, Minnesota  55905
USC/Norris Comprehensive Cancer CenterLos Angeles, California  90033-0800
University of Iowa Hospitals and ClinicsIowa City, Iowa  52242
Huntsman Cancer InstituteSalt Lake City, Utah  84112
Highlands Oncology Group, P.A.Fayetteville, Arkansas  72703
Frederick Memorial Hospital Regional Cancer Therapy CenterFrederick, Maryland  21701
Comprehensive Cancer CenterGlendale, California  91204
Dana Farber Cancer InstituteBoston, Massachusetts  02115
Providence Portland Medical CenterPortland, Oregon  97213-3635
University of ChicagoChicago, Illinois  60637
Alaska Clinical Research Center, LLCAnchorage, Alaska  99508
Pacific Hematology Oncology AssociatesSan Francisco, California  94115
Gabrail Cancer CenterCanton, Ohio  44718
Arizona Clinical Research Center, Inc.Tucson, Arizona  85712
The Center for Cancer and Blood DisordersFort Worth, Texas  76104
Kentucky Cancer ClinicPikeville, Kentucky  41501
Edward Cancer CenterNaperville, Illinois  60540
University of CincinnatiCincinnati, Ohio  45267-0502
Kansas City Veterans Affairs Medical CenterKansas City, Missouri  64128
Edwards Comprehensive Cancer CenterHuntington, West Virginia  25701
Raleigh Hematology Oncology AssociatesCary, North Carolina  27511
VA San Diego Healthcare SystemSan Diego, California  92161
M.D. Anderson Cancer Center OrlandoOrlando, Florida  32806
Baptist Cancer InstituteJacksonville, Florida  32207
Hutchinson Clinic, PAHutchinson, Kansas  67502
Cancer Care Specialists of Central IllinoisDecatur, Illinois  62256
Loma Linda University Cancer CenterLoma Linda, California  92354
Suburban Hematology-Oncology Associates, PcLawrenceville, Georgia  30046
The University Of Texas - M.D. Anderson Cancer CenterHouston, Texas  77030
MUSC Hollings Cancer CenterCharleston, South Carolina  29425
VA Pittsburgh Healthcare SystemPittsburgh, Pennsylvania  15240
Weill Cornell Medical CollegeNew York, New York  10021
Southern Cancer CenterMobile, Alabama  36608
Center For Oncology Research & Treatment, P.A.Dallas, Texas  75230
St Luke'S Hospital And Health NetworkBethlehem, Pennsylvania  18015
Associates In Hematology & Oncology, P.C.Upland, Pennsylvania  19013
Marsha G. Fink, Md, Inc.Fountain Valley, California  92708
Prostate Oncology Specialists, Inc.Marina Del Rey, California  90292
Mid-Illinois Hematology & Oncology Associates, LtdNormal, Illinois  61761
Siouxland Hematology-Oncology Assoc., LlpSioux City, Iowa  51101
The Bunting-Blaustein Cancer Research BuildingBaltimore, Maryland  21231
Mercy Medical Research InstituteSpringfield, Missouri  65807
Northwest Cancer CenterTuscon, Arizona  85704