Phase 3 Study of Immunotherapy to Treat Advanced Prostate Cancer

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01057810
• Other study ID #: CA184-095
• Secondary ID: 2009-016217-23
• Status: Completed
• Phase: Phase 3
• First received: January 26, 2010
• Last updated: September 2, 2015
• Start date: May 2010
• Est. completion date: July 2015

Study information

• Verified date: September 2015
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 602
• Est. completion date: July 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

• 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

Study Design

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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
• 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

Locations

Country	Name	City	State
Argentina	Local Institution	Buenos Aires
Argentina	Local Institution	Buenos Aires
Argentina	Local Institution	Buenos Aires
Argentina	Local Institution	Cordoba
Argentina	Local Institution	La Rioja
Argentina	Local Institution	Rosario	Santa Fe
Argentina	Local Institution	Rosario	Santa Fe
Australia	Local Institution	Ashford	South Australia
Australia	Local Institution	Box Hill	Victoria
Australia	Local Institution	East Bentleigh	Victoria
Australia	Local Institution	Frankston	Victoria
Australia	Local Institution	Heidelberg	Victoria
Australia	Local Institution	Kogarah	New South Wales
Australia	Local Institution	Subiaco	Western Australia
Brazil	Local Institution	Belo Horizonte	Minas Gerais
Brazil	Local Institution	Belo Horizonte - Mg	Minas Gerais
Brazil	Local Institution	Brasilia	Distrito Federal
Brazil	Local Institution	Ijui	Rio Grande Do Sul
Brazil	Local Institution	Porto Alegre	Rio Grande Do Sul
Canada	Local Institution	Kingston	Ontario
Canada	Local Institution	Montreal	Quebec
Canada	Local Institution	Quebec
Chile	Local Institution	Santiago
Chile	Local Institution	Temuco	Araucania
Chile	Local Institution	Vina Del Mar	Valparaiso
Colombia	Local Institution	Bogota
Colombia	Local Institution	Bucaramanga
Colombia	Local Institution	Medellin
Colombia	Local Institution	Monteria	Cordoba
Czech Republic	Local Institution	Hradec Kralove
Czech Republic	Local Institution	Liberec
Czech Republic	Local Institution	Praha 5
Czech Republic	Local Institution	Praha 8
Denmark	Local Institution	Herlev
Denmark	Local Institution	Kobenhavn O
France	Local Institution	Bordeaux
France	Local Institution	Clermont-ferrand
France	Local Institution	Marseille Cedex 9
France	Local Institution	Pointe A Pitre
France	Local Institution	Poitiers
France	Local Institution	Villejuif Cedex
Germany	Local Institution	Aachen
Germany	Local Institution	Heidelberg
Germany	Local Institution	Marktredwitz
Germany	Local Institution	Munich
Germany	Local Institution	Wesel
Greece	Local Institution	Athens
Hungary	Local Institution	Budapest
Hungary	Local Institution	Budapest
Hungary	Local Institution	Gyula
Hungary	Local Institution	Szekesfehervar
Italy	Local Institution	Meldola (FC)
Italy	Local Institution	Milano
Italy	Local Institution	Siena
Italy	Local Institution	Terni
Mexico	Local Institution	Guadalajara	Jalisco
Mexico	Local Institution	Mexico	Distrito Federal
Mexico	Local Institution	Mexico	Queretaro
Mexico	Local Institution	Mexico City	Distrito Federal
Mexico	Local Institution	San Luis Potosi
Mexico	Local Institution	Tlalpan	Distrito Federal
Mexico	Local Institution	Zapopan	Jalisco
Netherlands	Local Institution	Amsterdam
Netherlands	Local Institution	Sittard-geleen
Norway	Local Institution	Kristiansand
Poland	Local Institution	Gdansk
Poland	Local Institution	Koscierzyna
Poland	Local Institution	Krakow
Poland	Local Institution	Kutno
Poland	Local Institution	Lublin
Poland	Local Institution	Poznan
Poland	Local Institution	Slupsk
Puerto Rico	Va Caribbean Healthcare System	San Juan
Romania	Local Institution	Bucuresti
Romania	Local Institution	Cluj-napoca, Cluj County
Romania	Local Institution	Timisoara,timis County
Spain	Local Institution	Barcelona
Spain	Local Institution	Barcelona
Spain	Local Institution	Madrid
Spain	Local Institution	Sevilla
Spain	Local Institution	Valencia
Sweden	Local Institution	Stockholm
Sweden	Local Institution	Uppsala
Sweden	Local Institution	Vaxjo
Turkey	Local Institution	Adana
Turkey	Local Institution	Bornova, Izmir
Turkey	Local Institution	Gaziantep
Turkey	Local Institution	Kocaeli
Turkey	Local Institution	Kocaeli
United Kingdom	Local Institution	Birmingham	West Midlands
United Kingdom	Local Institution	Glasgow	Lanarkshire
United Kingdom	Local Institution	Guildford	Surrey
United States	Alaska Clinical Research Center, Llc	Anchorage	Alaska
United States	Northside Hospital	Atlanta	Georgia
United States	Georgia Regents University	Augusta	Georgia
United States	Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins	Baltimore	Maryland
United States	University Of Maryland	Baltimore	Maryland
United States	St. Luke'S Hospital & Health Network Laboratory	Bethlehem	Pennsylvania
United States	Lynn Cancer Institute Center For Hematology-Oncology	Boca Raton	Florida
United States	Montefiore Medical Center	Bronx	New York
United States	University Of Chicago	Chicago	Illinois
United States	Cancer Care Specialists Of Central Illinois	Decatur	Illinois
United States	North Shore Hematology/Oncology Associates, P.C.	East Setauket	New York
United States	Providence Regional Medical Center Everett	Everett	Washington
United States	Goshen Center For Cancer Care	Goshen	Indiana
United States	Goshen Medical Associates	Goshen	New York
United States	Cancer Center Of The Carolinas	Greenville	South Carolina
United States	Straub Clinic And Hospital	Honolulu	Hawaii
United States	Hutchinson Clinic, Pa	Hutchinson	Kansas
United States	Baptist Cancer Institute	Jacksonville	Florida
United States	Kansas City Veterans Affairs Medical Center	Kansas City	Missouri
United States	Comprehensive Cancer Centers Of Nevada	Las Vegas	Nevada
United States	Nevada Cancer Institute	Las Vegas	Nevada
United States	Gwinnett Hospital System Inc.	Lawrenceville	Georgia
United States	Mount Sinai Comprehensive Cancer Center	Miami Beach	Florida
United States	Carolina Urologic Research Center	Myrtle Beach	South Carolina
United States	Md Anderson Cancer Center Orlando	Orlando	Florida
United States	Hematology Oncology Associates Of The Treasure Coast	Port Saint Lucie	Florida
United States	Kaiser Permanente Oncology/Hematology	Portland	Oregon
United States	Oregon Health & Science University	Portland	Oregon
United States	Desert Hematology Oncology	Rancho Mirage	California
United States	Mayo Clinic	Rochester	Minnesota
United States	Utah Cancer Specialists	Salt Lake City	Utah
United States	Southern California Permanente Medical Group	San Diego	California
United States	Pacific Hematology Oncology Associates	San Francisco	California
United States	Pinnacle Oncology Hematology	Scottsdale	Arizona
United States	Stony Brook University Medical Center	Stony Brook	New York
United States	Suny Upstate Medical University	Syracuse	New York
United States	Scott & White Memorial Hospital And Clinic	Temple	Texas
United States	Arizona Cancer Center	Tucson	Arizona
United States	Tulsa Cancer Institute	Tulsa	Oklahoma
United States	George Washington University	Washington	District of Columbia
United States	Cancer Center Of Kansas	Wichita	Kansas
United States	Novant Health Oncology Specialists	Winston Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Brazil,  Canada,  Chile,  Colombia,  Czech Republic,  Denmark,  France,  Germany,  Greece,  Hungary,  Italy,  Mexico,  Netherlands,  Norway,  Poland,  Puerto Rico,  Romania,  Spain,  Sweden,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		Assessed at each study visit while on treatment and every 12 weeks during follow-up	No
Secondary	Compare Progression Free Survival (PFS) by collecting tumor assessments every 12 weeks until protocol defined progression or initiation of subsequent therapy for prostate cancer		each study visit while on treatment, and every 12 weeks during follow up until progression of disease or initiation of subsequent therapy for prostate cancer	No
Secondary	Compare time to pain progression by collection of a Patient Pain Diary prior to each treatment visit and every 12 weeks during follow up until progression of disease or initiation of subsequent therapy for prostate cancer		each study visit while on treatment, and every 12 weeks during follow up until progression of disease or initiation of subsequent therapy for prostate cancer	No
Secondary	Compare time to subsequent non-hormonal systemic therapy by collection of subsequent prostate cancer therapies during follow up		Every 12 weeks during follow up until initiation of subequent non-hormonal systemic therapy for prostate cancer	No
Secondary	Characterize Safety Profile by collection of adverse event information and review of laboratory values at every study visit		Continuously throughout study and during follow up until all toxicities have resolved, returned to baseline or been deemed irreversible	Yes

External Links

•   BMS clinical trial educational resource
•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry form