Know Cancer

forgot password

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

Phase 3
18 Years
Open (Enrolling)
Prostate Cancer

Thank you

Trial Information

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

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

Type of Study:


Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

Assessed at each study visit while on treatment and every 12 weeks during follow-up

Safety Issue:


Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb


United States: Food and Drug Administration

Study ID:




Start Date:

July 2010

Completion Date:

November 2015

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms



Arizona Cancer Center Tucson, Arizona  85724
Mayo Clinic Rochester, Minnesota  55905
MD Anderson Cancer Center Orlando Orlando, Florida  32806
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410
Southern California Permanente Medical Group Downey, California  90242
Montefiore Medical Center Bronx, New York  10467-2490
Cancer Centers of the Carolinas Greenville, South Carolina  29605
Mount Sinai Comprehensive Cancer Center Miami Beach, Florida  33140
Georgia Cancer Specialists Decatur, Georgia  30033
Ellis Fischel Cancer Center Columbia, Missouri  65203
Wenatchee Valley Medical Center Wenatchee, Washington  98801-2028
SUNY Upstate Medical University Syracuse, New York  13210
University of Florida Gainesville, Florida  32610-0277
Comprehensive Cancer Center Glendale, California  91204
Straub Clinic and Hospital Honolulu, Hawaii  96813
Goshen Medical Associates Goshen, New York  10924
University of Maryland Baltimore, Maryland  21201
University of Chicago Chicago, Illinois  60637
Alaska Clinical Research Center, LLC Anchorage, Alaska  99508
George Washington University Washington, District of Columbia  20037
Pacific Hematology Oncology Associates San Francisco, California  94115
Oregon Health and Science University Portland, Oregon  97201
Hematology Oncology Associates of the Treasure Coast Port St. Lucie, Florida  34952
Kentucky Cancer Clinic Pikeville, Kentucky  41501
Carolina Urologic Research Center Myrtle Beach, South Carolina  29572
Nevada Cancer Institute Las Vegas, Nevada  89135
Kansas City Veterans Affairs Medical Center Kansas City, Missouri  64128
Cancer Center of Kansas Wichita, Kansas  67214
Maine Center for Cancer Medicine Scarborough, Maine  04074
Syracuse VA Medical Center Syracuse, New York  13210
Baptist Cancer Institute Jacksonville, Florida  32207
Hutchinson Clinic, PA Hutchinson, Kansas  67502
Cancer Care Specialists of Central Illinois Decatur, Illinois  62256
Stony Brook University Medical Center Stony Brook, New York  11794
Suburban Hematology-Oncology Associates, Pc Lawrenceville, Georgia  30046
Kaiser Permanente Oncology/Hematology Portland, Oregon  97227
St Luke'S Hospital And Health Network Bethlehem, Pennsylvania  18015
IU Health Goshen Center for Cancer Care Goshen, Indiana  46526
Loyola University Chicago Maywood, Illinois  60153
Pinnacle Oncology Hematology Scottsdale, Arizona  85258
Scott & White Memorial Hospital and Clinic Temple, Texas  76508
Prostate Oncology Specialists, Inc. Marina Del Rey, California  90292
Georgia Health Sciences University Augusta, Georgia  30912
John Theurer Cancer Center Hackensack, New Jersey  07601
Desert Hematology Oncology Rancho Mirage, California  92270
Lynn Cancer Institute Center For Hematology-Oncology Boca Raton, Florida  33486
Colmery-O'Neil Va Medical Center Topeka, Kansas  66622
Timothy S. Collins, Md Winston Salem, North Carolina  27103
Providence Regional Medical Center Everett Everett, Washington  98201
Tulsa Cancer Institute, Pllc Tulsa, Oklahoma  74136