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
18 Years
N/A
Male
Prostate Cancer
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 |
