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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
N/A
Open (Enrolling)
Male
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:

Interventional

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:

No

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA184-095

NCT ID:

NCT01057810

Start Date:

July 2010

Completion Date:

November 2015

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms

Name

Location

Arizona Cancer CenterTucson, Arizona  85724
Mayo ClinicRochester, Minnesota  55905
MD Anderson Cancer Center OrlandoOrlando, Florida  32806
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
Southern California Permanente Medical GroupDowney, California  90242
Montefiore Medical CenterBronx, New York  10467-2490
Cancer Centers of the CarolinasGreenville, South Carolina  29605
Mount Sinai Comprehensive Cancer CenterMiami Beach, Florida  33140
Georgia Cancer SpecialistsDecatur, Georgia  30033
Ellis Fischel Cancer CenterColumbia, Missouri  65203
Wenatchee Valley Medical CenterWenatchee, Washington  98801-2028
SUNY Upstate Medical UniversitySyracuse, New York  13210
University of FloridaGainesville, Florida  32610-0277
Comprehensive Cancer CenterGlendale, California  91204
Straub Clinic and HospitalHonolulu, Hawaii  96813
Goshen Medical AssociatesGoshen, New York  10924
University of MarylandBaltimore, Maryland  21201
University of ChicagoChicago, Illinois  60637
Alaska Clinical Research Center, LLCAnchorage, Alaska  99508
George Washington UniversityWashington, District of Columbia  20037
Pacific Hematology Oncology AssociatesSan Francisco, California  94115
Oregon Health and Science UniversityPortland, Oregon  97201
Hematology Oncology Associates of the Treasure CoastPort St. Lucie, Florida  34952
Kentucky Cancer ClinicPikeville, Kentucky  41501
Carolina Urologic Research CenterMyrtle Beach, South Carolina  29572
Nevada Cancer InstituteLas Vegas, Nevada  89135
Kansas City Veterans Affairs Medical CenterKansas City, Missouri  64128
Cancer Center of KansasWichita, Kansas  67214
Maine Center for Cancer MedicineScarborough, Maine  04074
Syracuse VA Medical CenterSyracuse, New York  13210
Baptist Cancer InstituteJacksonville, Florida  32207
Hutchinson Clinic, PAHutchinson, Kansas  67502
Cancer Care Specialists of Central IllinoisDecatur, Illinois  62256
Stony Brook University Medical CenterStony Brook, New York  11794
Suburban Hematology-Oncology Associates, PcLawrenceville, Georgia  30046
Kaiser Permanente Oncology/HematologyPortland, Oregon  97227
St Luke'S Hospital And Health NetworkBethlehem, Pennsylvania  18015
IU Health Goshen Center for Cancer CareGoshen, Indiana  46526
Loyola University ChicagoMaywood, Illinois  60153
Pinnacle Oncology HematologyScottsdale, Arizona  85258
Scott & White Memorial Hospital and ClinicTemple, Texas  76508
Prostate Oncology Specialists, Inc.Marina Del Rey, California  90292
Georgia Health Sciences UniversityAugusta, Georgia  30912
John Theurer Cancer CenterHackensack, New Jersey  07601
Desert Hematology OncologyRancho Mirage, California  92270
Lynn Cancer Institute Center For Hematology-OncologyBoca Raton, Florida  33486
Colmery-O'Neil Va Medical CenterTopeka, Kansas  66622
Timothy S. Collins, MdWinston Salem, North Carolina  27103
Providence Regional Medical Center EverettEverett, Washington  98201
Tulsa Cancer Institute, PllcTulsa, Oklahoma  74136