Clinical trial NCT02279862: Safety and Efficacy Study of Ipilimumab 3 mg/kg Versus Ipilimumab 10 mg/kg in Subjects With Metastatic Castration Resistant Prostate Cancer Who Are Chemotherapy Naive
Official title: A Phase 2, Randomized, Double-Blind Study of Ipilimumab Administered at 3 mg/kg vs 10 mg/kg in Adult Subjects With Metastatic Chemotherapy-Naïve Castration Resistant Prostate Cancer Who Are Asymptomatic or Minimally Symptomatic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2014-10-31
Enrollment: 82
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 examine the safety and effectiveness (how well the drug works) of two different doses (3 mg/kg and 10 mg/kg) of Ipilimumab (Yervoy™) in patients with metastatic castration resistant prostate cancer.

Detailed description: Prostate Cancer Clinical Trials Working Group 2 (PCWG2)

Response Evaluation Criteria In Solid Tumors (RECIST)

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

Inclusion Criteria:

* Prostate cancer with metastases
* Prostate cancer should be castration resistant
* Progression during hormonal therapy

Exclusion Criteria:

* Visceral metastases (eg liver, lung or brain metastases)
* Prior treatment with any immunotherapy for prostate cancer
* Prior or ongoing cytotoxic therapy for prostate cancer
* Autoimmune disease
* Inadequate hematologic, renal, or hepatic function

Primary outcomes:
measure: Radiographic Progression-free Survival (rPFS)
timeFrame: From date of randomization until disease progression or death (assessed up to December 2016, approximately 24 months)
Secondary outcomes:
measure: Number of Participants Who Experienced Immune-related Adverse Events (irAEs)
timeFrame: From first dose of ipilimumab to last dose plus 90 days
measure: Overall Survival (OS)
timeFrame: From randomization to death from any cause (assessed up to December 2016, approximately 24 months)
measure: Prostate Specific Antigen Progression-free Survival (PSA PFS)
timeFrame: From randomization to the earliest date of PSA progression or death, whichever comes earlier (assessed up to December 2016, approximately 24 months)
measure: Time to Pain Progression
timeFrame: From randomization until pain progression (assessed up to December 2016, approximately 24 months)
measure: Prostate Specific Antigen Response Rate
timeFrame: From baseline to PSA response (assessed up to December 2016, approximately 48 months)
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco Oncology Associates
state: California
city: Washington
country: United States
facility: George Washington University Medical Center
state: District of Columbia
city: Jacksonville
country: United States
facility: Baptist Cancer Institute
state: Florida
city: Wichita
country: United States
facility: Cancer Center Of Kansas
state: Kansas
city: Tupelo
country: United States
facility: North Mississippi Med Center
state: Mississippi
city: Omaha
country: United States
facility: Nebraska Cancer Specialists
state: Nebraska
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Tualatin
country: United States
facility: Northwest Cancer Specialists, Pc
state: Oregon
city: Pittsburgh
country: United States
facility: University of Pittsburgh Cancer Institute Cancer Services
state: Pennsylvania
city: Houston
country: United States
facility: Texas Oncology
state: Texas
city: Richmond
country: United States
facility: Virginia Cancer Institute
state: Virginia
city: St Leonards
country: Australia
facility: Local Institution
state: New South Wales
city: Wahroonga
country: Australia
facility: Local Institution
state: New South Wales
city: Parkville
country: Australia
facility: Local Institution
state: Victoria
city: Santiago
country: Chile
facility: Local Institution
state: Metropolitana
city: Recoleta
country: Chile
facility: Local Institution
state: Santiago DE Chile
city: Vina Del Mar
country: Chile
facility: Local Institution
state: Valparaiso
city: Clermont Ferrand cedex 01
country: France
facility: Local Institution
city: Marseille Cedex 9
country: France
facility: Local Institution
city: Poitiers
country: France
facility: Local Institution
city: Rennes Cedex
country: France
facility: Local Institution
city: Saint Herblain
country: France
facility: Local Institution
city: Villejuif
country: France
facility: Local Institution
city: Aachen
country: Germany
facility: Universitaetsklinikum Aachen
city: Heidelberg
country: Germany
facility: Uniklinik Heidelberg
city: Jena
country: Germany
facility: Universitaetsklinikum Jena
city: Magdeburg
country: Germany
facility: Universitaetsklinikum Magdeburg
city: Mannheim
country: Germany
facility: Universitaetsklinikum Mannheim
city: Marktredwitz
country: Germany
facility: Local Institution
city: Muenchen
country: Germany
facility: Klinikum rechts der Isar der TU
city: Rostock
country: Germany
facility: Urologische Praxis
city: Wesel
country: Germany
facility: Urologische Gemeinschaftspraxis Dres Stammel U. Garcia
city: Wuppertal
country: Germany
facility: Dgu Urologie
city: Milano
country: Italy
facility: Local Institution
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori Fondazione Pascale
city: Amsterdam
country: Netherlands
facility: Local Institution
city: Barcelona
country: Spain
facility: Local Institution
city: Hospitalet de Llobregat - Barcelona
country: Spain
facility: Local Institution
city: Sevilla
country: Spain
facility: Local Institution
city: Valencia
country: Spain
facility: Local Institution
city: Glasgow
country: United Kingdom
facility: Local Institution
state: Lanarkshire
city: Nottingham
country: United Kingdom
facility: Local Institution
state: Nottinghamshire
city: Guildford
country: United Kingdom
facility: Local Institution
state: Surrey
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: