Clinical trial NCT01057810: Phase 3 Study of Immunotherapy to Treat Advanced Prostate Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2010-01-27
Enrollment: 837
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if asymptomatic or minimally symptomatic patients with metastatic prostate cancer who have not received chemotherapy live longer when treated with ipilimumab than those treated with a placebo


Eligibility criteria: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Metastatic prostate cancer
* Asymptomatic or minimally symptomatic
* Progression during hormonal therapy
* Eastern Cooperative Oncology Group (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

Primary outcomes:
measure: Overall Survival (OS) Time
timeFrame: Randomization until death from any cause, up to April 2015, approximately 57 months
Secondary outcomes:
measure: Progression-Free Survival (PFS) Time
timeFrame: Randomization until disease progression, up to April 2015, approximately 57 months
measure: Time to Subsequent Non-hormonal Cytotoxic Therapy
timeFrame: Randomization until subsequent non-hormonal cytotoxic therapy, up to April 2015, approximately 57 months
measure: Time to Pain Progression
timeFrame: Randomization until pain progression, up to April 2015, approximately 57 months
measure: Number of Participants Who Died or Had Adverse Events (AEs), Serious Adverse Events (SAEs), Immune-related AEs (irAEs), or Immune-mediated Adverse Reactions (imARs)
timeFrame: Day 1 of study therapy to last dose plus 70 days
measure: Number of Treated Participants With Grade 3 or 4 Clinical Laboratory Abnormalities
timeFrame: Randomization up to April 2015, approximately 57 months
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Alaska Clinical Research Center, Llc
state: Alaska
city: Scottsdale
country: United States
facility: Pinnacle Oncology Hematology
state: Arizona
city: Tucson
country: United States
facility: Arizona Cancer Center
state: Arizona
city: Rancho Mirage
country: United States
facility: Desert Hematology Oncology
state: California
city: San Diego
country: United States
facility: Southern California Permanente Medical Group
state: California
city: San Francisco
country: United States
facility: Pacific Hematology Oncology Associates
state: California
city: Washington
country: United States
facility: George Washington University
state: District of Columbia
city: Boca Raton
country: United States
facility: Lynn Cancer Institute Center For Hematology-Oncology
state: Florida
city: Jacksonville
country: United States
facility: Baptist Cancer Institute
state: Florida
city: Miami Beach
country: United States
facility: Mount Sinai Comprehensive Cancer Center
state: Florida
city: Orlando
country: United States
facility: Md Anderson Cancer Center Orlando
state: Florida
city: Port Saint Lucie
country: United States
facility: Hematology Oncology Associates Of The Treasure Coast
state: Florida
city: Atlanta
country: United States
facility: Northside Hospital
state: Georgia
city: Augusta
country: United States
facility: Georgia Regents University
state: Georgia
city: Lawrenceville
country: United States
facility: Gwinnett Hospital System Inc.
state: Georgia
city: Honolulu
country: United States
facility: Straub Clinic And Hospital
state: Hawaii
city: Chicago
country: United States
facility: University Of Chicago
state: Illinois
city: Decatur
country: United States
facility: Cancer Care Specialists Of Central Illinois
state: Illinois
city: Goshen
country: United States
facility: Goshen Center For Cancer Care
state: Indiana
city: Hutchinson
country: United States
facility: Hutchinson Clinic, Pa
state: Kansas
city: Wichita
country: United States
facility: Cancer Center Of Kansas
state: Kansas
city: Baltimore
country: United States
facility: University Of Maryland
state: Maryland
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
state: Maryland
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Kansas City
country: United States
facility: Kansas City Veterans Affairs Medical Center
state: Missouri
city: Las Vegas
country: United States
facility: Nevada Cancer Institute
state: Nevada
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers Of Nevada
state: Nevada
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: East Setauket
country: United States
facility: North Shore Hematology/Oncology Associates, P.C.
state: New York
city: Goshen
country: United States
facility: Goshen Medical Associates
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center
state: New York
city: Syracuse
country: United States
facility: Suny Upstate Medical University
state: New York
city: Winston Salem
country: United States
facility: Novant Health Oncology Specialists
state: North Carolina
city: Tulsa
country: United States
facility: Tulsa Cancer Institute
state: Oklahoma
city: Portland
country: United States
facility: Kaiser Permanente Oncology/Hematology
state: Oregon
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Bethlehem
country: United States
facility: St. Luke'S Hospital & Health Network Laboratory
state: Pennsylvania
city: Greenville
country: United States
facility: Cancer Center Of The Carolinas
state: South Carolina
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center
state: South Carolina
city: Temple
country: United States
facility: Scott & White Memorial Hospital And Clinic
state: Texas
city: Salt Lake City
country: United States
facility: Utah Cancer Specialists
state: Utah
city: Everett
country: United States
facility: Providence Regional Medical Center Everett
state: Washington
city: Rosario
country: Argentina
facility: Local Institution
state: Santa Fe
city: Rosario
country: Argentina
facility: Local Institution
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Local Institution
city: Buenos Aires
country: Argentina
facility: Local Institution
city: Buenos Aires
country: Argentina
facility: Local Institution
city: Cordoba
country: Argentina
facility: Local Institution
city: La Rioja
country: Argentina
facility: Local Institution
city: Kogarah
country: Australia
facility: Local Institution
state: New South Wales
city: Ashford
country: Australia
facility: Local Institution
state: South Australia
city: Box Hill
country: Australia
facility: Local Institution
state: Victoria
city: East Bentleigh
country: Australia
facility: Local Institution
state: Victoria
city: Frankston
country: Australia
facility: Local Institution
state: Victoria
city: Heidelberg
country: Australia
facility: Local Institution
state: Victoria
city: Subiaco
country: Australia
facility: Local Institution
state: Western Australia
city: Brasilia
country: Brazil
facility: Local Institution
state: Distrito Federal
city: Belo Horizonte - Mg
country: Brazil
facility: Local Institution
state: Minas Gerais
city: Belo Horizonte
country: Brazil
facility: Local Institution
state: Minas Gerais
city: Ijui
country: Brazil
facility: Local Institution
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Local Institution
state: Rio Grande Do Sul
city: Kingston
country: Canada
facility: Local Institution
state: Ontario
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: Quebec
country: Canada
facility: Local Institution
city: Temuco
country: Chile
facility: Local Institution
state: Araucania
city: Vina Del Mar
country: Chile
facility: Local Institution
state: Valparaiso
city: Santiago
country: Chile
facility: Local Institution
city: Monteria
country: Colombia
facility: Local Institution
state: Cordoba
city: Bogota
country: Colombia
facility: Local Institution
city: Bucaramanga
country: Colombia
facility: Local Institution
city: Medellin
country: Colombia
facility: Local Institution
city: Hradec Kralove
country: Czech Republic
facility: Local Institution
city: Liberec
country: Czech Republic
facility: Local Institution
city: Praha 5
country: Czech Republic
facility: Local Institution
city: Praha 8
country: Czech Republic
facility: Local Institution
city: Herlev
country: Denmark
facility: Local Institution
city: Kobenhavn O
country: Denmark
facility: Local Institution
city: Bordeaux
country: France
facility: Local Institution
city: Clermont-ferrand
country: France
facility: Local Institution
city: Marseille Cedex 9
country: France
facility: Local Institution
city: Pointe A Pitre
country: France
facility: Local Institution
city: Poitiers
country: France
facility: Local Institution
city: Villejuif Cedex
country: France
facility: Local Institution
city: Aachen
country: Germany
facility: Local Institution
city: Heidelberg
country: Germany
facility: Local Institution
city: Marktredwitz
country: Germany
facility: Local Institution
city: Munich
country: Germany
facility: Local Institution
city: Wesel
country: Germany
facility: Local Institution
city: Athens
country: Greece
facility: Local Institution
city: Budapest
country: Hungary
facility: Local Institution
city: Budapest
country: Hungary
facility: Local Institution
city: Gyula
country: Hungary
facility: Local Institution
city: Szekesfehervar
country: Hungary
facility: Local Institution
city: Meldola (FC)
country: Italy
facility: Local Institution
city: Milano
country: Italy
facility: Local Institution
city: Siena
country: Italy
facility: Local Institution
city: Terni
country: Italy
facility: Local Institution
city: Mexico City
country: Mexico
facility: Local Institution
state: Distrito Federal
city: Mexico
country: Mexico
facility: Local Institution
state: Distrito Federal
city: Tlalpan
country: Mexico
facility: Local Institution
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Local Institution
state: Jalisco
city: Zapopan
country: Mexico
facility: Local Institution
state: Jalisco
city: Mexico
country: Mexico
facility: Local Institution
state: Queretaro
city: San Luis Potosi
country: Mexico
facility: Local Institution
city: Amsterdam
country: Netherlands
facility: Local Institution
city: Sittard-geleen
country: Netherlands
facility: Local Institution
city: Kristiansand
country: Norway
facility: Local Institution
city: Gdansk
country: Poland
facility: Local Institution
city: Koscierzyna
country: Poland
facility: Local Institution
city: Krakow
country: Poland
facility: Local Institution
city: Kutno
country: Poland
facility: Local Institution
city: Lublin
country: Poland
facility: Local Institution
city: Poznan
country: Poland
facility: Local Institution
city: Slupsk
country: Poland
facility: Local Institution
city: San Juan
country: Puerto Rico
facility: Va Caribbean Healthcare System
city: Bucuresti
country: Romania
facility: Local Institution
city: Cluj-napoca, Cluj County
country: Romania
facility: Local Institution
city: Timisoara,timis County
country: Romania
facility: Local Institution
city: Barcelona
country: Spain
facility: Local Institution
city: Barcelona
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Sevilla
country: Spain
facility: Local Institution
city: Valencia
country: Spain
facility: Local Institution
city: Stockholm
country: Sweden
facility: Local Institution
city: Uppsala
country: Sweden
facility: Local Institution
city: Vaxjo
country: Sweden
facility: Local Institution
city: Adana
country: Turkey
facility: Local Institution
city: Bornova, Izmir
country: Turkey
facility: Local Institution
city: Gaziantep
country: Turkey
facility: Local Institution
city: Kocaeli
country: Turkey
facility: Local Institution
city: Kocaeli
country: Turkey
facility: Local Institution
city: Glasgow
country: United Kingdom
facility: Local Institution
state: Lanarkshire
city: Guildford
country: United Kingdom
facility: Local Institution
state: Surrey
city: Birmingham
country: United Kingdom
facility: Local Institution
state: West Midlands
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: de Liano AG, Reig O, Mellado B, Martin C, Rull EU, Maroto JP. Prognostic and predictive value of plasma testosterone levels in patients receiving first-line chemotherapy for metastatic castrate-resistant prostate cancer. Br J Cancer. 2014 Apr 29;110(9):2201-8. doi: 10.1038/bjc.2014.189. Epub 2014 Apr 10.
citation: Dayyani F, Gallick GE, Logothetis CJ, Corn PG. Novel therapies for metastatic castrate-resistant prostate cancer. J Natl Cancer Inst. 2011 Nov 16;103(22):1665-75. doi: 10.1093/jnci/djr362. Epub 2011 Sep 13.