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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 Center New York, New York  10021
Mayo Clinic Rochester, Minnesota  55905
USC/Norris Comprehensive Cancer Center Los Angeles, California  90033-0800
University of Iowa Hospitals and Clinics Iowa City, Iowa  52242
Huntsman Cancer Institute Salt Lake City, Utah  84112
Highlands Oncology Group, P.A. Fayetteville, Arkansas  72703
Frederick Memorial Hospital Regional Cancer Therapy Center Frederick, Maryland  21701
Comprehensive Cancer Center Glendale, California  91204
Dana Farber Cancer Institute Boston, Massachusetts  02115
Providence Portland Medical Center Portland, Oregon  97213-3635
University of Chicago Chicago, Illinois  60637
Alaska Clinical Research Center, LLC Anchorage, Alaska  99508
Pacific Hematology Oncology Associates San Francisco, California  94115
Gabrail Cancer Center Canton, Ohio  44718
Arizona Clinical Research Center, Inc. Tucson, Arizona  85712
The Center for Cancer and Blood Disorders Fort Worth, Texas  76104
Kentucky Cancer Clinic Pikeville, Kentucky  41501
Edward Cancer Center Naperville, Illinois  60540
University of Cincinnati Cincinnati, Ohio  45267-0502
Kansas City Veterans Affairs Medical Center Kansas City, Missouri  64128
Edwards Comprehensive Cancer Center Huntington, West Virginia  25701
Raleigh Hematology Oncology Associates Cary, North Carolina  27511
VA San Diego Healthcare System San Diego, California  92161
M.D. Anderson Cancer Center Orlando Orlando, Florida  32806
Baptist Cancer Institute Jacksonville, Florida  32207
Hutchinson Clinic, PA Hutchinson, Kansas  67502
Cancer Care Specialists of Central Illinois Decatur, Illinois  62256
Loma Linda University Cancer Center Loma Linda, California  92354
Suburban Hematology-Oncology Associates, Pc Lawrenceville, Georgia  30046
The University Of Texas - M.D. Anderson Cancer Center Houston, Texas  77030
MUSC Hollings Cancer Center Charleston, South Carolina  29425
VA Pittsburgh Healthcare System Pittsburgh, Pennsylvania  15240
Weill Cornell Medical College New York, New York  10021
Southern Cancer Center Mobile, Alabama  36608
Center For Oncology Research & Treatment, P.A. Dallas, Texas  75230
St Luke'S Hospital And Health Network Bethlehem, 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, Ltd Normal, Illinois  61761
Siouxland Hematology-Oncology Assoc., Llp Sioux City, Iowa  51101
The Bunting-Blaustein Cancer Research Building Baltimore, Maryland  21231
Mercy Medical Research Institute Springfield, Missouri  65807
Northwest Cancer Center Tuscon, Arizona  85704