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

Part of paid clinical trials in San Francisco, California.

Sponsor
Bristol-Myers Squibb
Study ID
NCT02279862
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Dec 2, 2014
Status verified
Aug 2019
Primary completion
Dec 15, 2016
Completion
Dec 15, 2016

Study Design

Enrollment
82 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: Ipilimumab 3 mg/kg
    Ipilimumab 3 mg/kg injection intravenously every 3 weeks for 4 doses in Induction phase. Subjects that are eligible to receive Ipilimumab in the Maintenance phase will be dosed every 12 weeks for a maximum of 3 years since the first induction dose
  • Experimental: Arm 2: Ipilimumab 10 mg/kg
    Ipilimumab 10 mg/kg injection intravenously every 3 weeks for 4 doses in Induction phase. Subjects that are eligible to receive Ipilimumab in the Maintenance phase will be dosed every 12 weeks for a maximum of 3 years since the first induction dose

Primary Outcome Measure

Radiographic Progression-free Survival (rPFS) [ Time Frame: From date of randomization until disease progression or death (assessed up to December 2016, approximately 24 months) ]

Locations (11)

FacilityCityStateZIPSite coordinators
San Francisco Oncology AssociatesSan FranciscoCalifornia94115-
George Washington University Medical CenterWashington D.C.District of Columbia20037-
Baptist Cancer InstituteJacksonvilleFlorida32207-
Cancer Center Of KansasWichitaKansas67214-
North Mississippi Med CenterTupeloMississippi38801-
Nebraska Cancer SpecialistsOmahaNebraska68130-
Providence Portland Medical CenterPortlandOregon97213-
Northwest Cancer Specialists, PcTualatinOregon97062-
University of Pittsburgh Cancer Institute Cancer ServicesPittsburghPennsylvania15232-1305-
Texas OncologyHoustonTexas77024-
Virginia Cancer InstituteRichmondVirginia23230-

Find similar trials in San Francisco, CA

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
San Francisco Oncology Associates· San Francisco, CAGeorge Washington University Medical Center· Washington D.C., DCBaptist Cancer Institute· Jacksonville, FLCancer Center Of Kansas· Wichita, KSNorth Mississippi Med Center· Tupelo, MSNebraska Cancer Specialists· Omaha, NE

Related Studies