Phase 3 Study of Immunotherapy to Treat Advanced Prostate Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

837

Participants

Timeline

Start Date

July 31, 2010

Primary Completion Date

April 30, 2015

Study Completion Date

July 31, 2015

Conditions
Prostate Cancer
Interventions
DRUG

Ipilimumab

5 mg/ml solution, Intravenous, 10 mg/kg, Every 3 weeks for up to 4 doses in the Induction Phase. Every 12 weeks in the Maintenance Phase. Up to 24 weeks in the Induction Phase. Treatment in the Maintenance Phase continues until total treatment period has reached three years,Treatment Stopping Criteria are met, withdrawal of consent, or study closure

DRUG

Placebo

Solution, Intravenous, 0 mg, Every 3 weeks for up to 4 doses in the Induction Phase. Every 12 weeks in the Maintenance Phase. Up to 24 weeks in the Induction Phase. Treatment in the Maintenance Phase continues until total treatment period has reached three years,Treatment Stopping Criteria are met, withdrawal of consent, or study closure

Trial Locations (134)

1064

Local Institution, Budapest

1120

Local Institution, Buenos Aires

1145

Local Institution, Budapest

2100

Local Institution, København Ø

2217

Local Institution, Kogarah

2730

Local Institution, Herlev

3084

Local Institution, Heidelberg

3128

Local Institution, Box Hill

3165

Local Institution, East Bentleigh

3199

Local Institution, Frankston

4604

Local Institution, Kristiansand

5035

Local Institution, Ashford

5300

Local Institution, La Rioja

5700

Local Institution, Gyula

6008

Local Institution, Subiaco

10461

Montefiore Medical Center, The Bronx

10924

Goshen Medical Associates, Goshen

11733

North Shore Hematology/Oncology Associates, P.C., East Setauket

11794

Stony Brook University Medical Center, Stony Brook

13210

Suny Upstate Medical University, Syracuse

13273

Local Institution, Marseille

14080

Local Institution, Tlalpan

18015

St. Luke'S Hospital & Health Network Laboratory, Bethlehem

20037

George Washington University, Washington D.C.

21201

University Of Maryland, Baltimore

21231

Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins, Baltimore

27103

Novant Health Oncology Specialists, Winston-Salem

27310

Local Institution, Gaziantep

28040

Local Institution, Madrid

29572

Carolina Urologic Research Center, Myrtle Beach

29615

Cancer Center Of The Carolinas, Greenville

30046

Gwinnett Hospital System Inc., Lawrenceville

30150

Local Institution, Belo Horizonte

30341

Northside Hospital, Atlanta

30912

Georgia Regents University, Augusta

31150

Local Institution, Belo Horizonte - Mg

32207

Baptist Cancer Institute, Jacksonville

32806

Md Anderson Cancer Center Orlando, Orlando

33075

Local Institution, Bordeaux

33140

Mount Sinai Comprehensive Cancer Center, Miami Beach

33486

Lynn Cancer Institute Center For Hematology-Oncology, Boca Raton

34952

Hematology Oncology Associates Of The Treasure Coast, Port Saint Lucie

35100

Local Institution, Bornova, Izmir

41071

Local Institution, Seville

41380

Local Institution, Kocaeli

41400

Local Institution, Kocaeli

44280

Local Institution, Guadalajara

45150

Local Institution, Zapopan

46009

Local Institution, Valencia

46483

Local Institution, Wesel

46526

Goshen Center For Cancer Care, Goshen

47014

Local Institution, Meldola (FC)

52074

Local Institution, Aachen

53100

Local Institution, Siena

55905

Mayo Clinic, Rochester

60637

University Of Chicago, Chicago

62526

Cancer Care Specialists Of Central Illinois, Decatur

63000

Local Institution, Clermont-Ferrand

64128

Kansas City Veterans Affairs Medical Center, Kansas City

67214

Cancer Center Of Kansas, Wichita

67502

Hutchinson Clinic, Pa, Hutchinson

69120

Local Institution, Heidelberg

72115

Local Institution, Brasília

74136

Tulsa Cancer Institute, Tulsa

76200

Local Institution, México

76508

Scott & White Memorial Hospital And Clinic, Temple

78240

Local Institution, San Luis Potosí City

81675

Local Institution, Munich

84106

Utah Cancer Specialists, Salt Lake City

85258

Pinnacle Oncology Hematology, Scottsdale

85724

Arizona Cancer Center, Tucson

86000

Local Institution, Poitiers

89135

Nevada Cancer Institute, Las Vegas

89148

Comprehensive Cancer Centers Of Nevada, Las Vegas

90430

Local Institution, Porto Alegre

92108

Southern California Permanente Medical Group, San Diego

92270

Desert Hematology Oncology, Rancho Mirage

94115

Pacific Hematology Oncology Associates, San Francisco

94805

Local Institution, Villejuif

95615

Local Institution, Marktredwitz

96813

Straub Clinic And Hospital, Honolulu

97159

Local Institution, Pointe à Pitre

97227

Kaiser Permanente Oncology/Hematology, Portland

97239

Oregon Health & Science University, Portland

98201

Providence Regional Medical Center Everett, Everett

98700

Local Institution, Ijuí

99508

Alaska Clinical Research Center, Llc, Anchorage

300376

Local Institution, Timisoara,timis County

400046

Local Institution, Cluj-napoca, Cluj County

2540364

Local Institution, Viña del Mar

4810469

Local Institution, Temuco

C1280AEB

Local Institution, Buenos Aires

C1426BOS

Local Institution, Buenos Aires

X5006HBF

Local Institution, Córdoba

S2000DSK

Local Institution, Rosario

S2000DSV

Local Institution, Rosario

K7L 2V7

Local Institution, Kingston

H2X 0A9

Local Institution, Montreal

G1R 2J6

Local Institution, Québec

Unknown

Local Institution, Santiago

Local Institution, Montería

Local Institution, Bogotá

Local Institution, Bucaramanga

MEDELLIN

Local Institution, Medellín

500 05

Local Institution, Hradec Králové

460 63

Local Institution, Liberec

150 30

Local Institution, Prague

180 81

Local Institution, Prague

115 28

Local Institution, Athens

H-8000

Local Institution, Székesfehérvár

I-20132

Local Institution, Milan

05100

Local Institution, Terni

06726

Local Institution, Mexico City

07760

Local Institution, Mexico City

1081HV

Local Institution, Amsterdam

6162 BG

Local Institution, Sittard-geleen

80-402

Local Institution, Gdansk

83-400

Local Institution, Kościerzyna

30-017

Local Institution, Krakow

99-300

Local Institution, Kutno

20-090

Local Institution, Lublin

60-693

Local Institution, Poznan

76-200

Local Institution, Słupsk

00921

Va Caribbean Healthcare System, San Juan

022328

Local Institution, Bucharest

08036

Local Institution, Barcelona

08907

Local Institution, Barcelona

171 76

Local Institution, Stockholm

751 85

Local Institution, Uppsala

351 85

Local Institution, Vaxjo

01330

Local Institution, Adana

G12 0YN

Local Institution, Glasgow

GU2 7WG

Local Institution, Guildford

B9 5SS

Local Institution, Birmingham

Sponsors
All Listed Sponsors
lead

Bristol-Myers Squibb

INDUSTRY