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
- Registration Number
- NCT02279862
- Lead Sponsor
- Bristol-Myers Squibb
- 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)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 82
- Prostate cancer with metastases
- Prostate cancer should be castration resistant
- Progression during hormonal therapy
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1: Ipilimumab 3 mg/kg Ipilimumab 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 Arm 2: Ipilimumab 10 mg/kg Ipilimumab 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 Measures
Name Time Method Radiographic Progression-free Survival (rPFS) From date of randomization until disease progression or death (assessed up to December 2016, approximately 24 months) rPFS was defined as the time from the date of randomization until the date of disease progression based on radiographic evidence and/or death from any cause, whichever occurs first. Radiographic disease progression is defined as: Confirmed bone disease progression according to criteria adapted from the Prostate Cancer Clinical Trials Working Group 2 (PCWG2), OR Non-bone disease progression according to the modified Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. After termination of the study, collection of tumor assessments and other data to support the efficacy analyses was no longer required in patients who discontinued study treatment. As a result, the presented efficacy results are based on limited data. The number of participants with reported radiographic progression is shown.
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) From randomization to death from any cause (assessed up to December 2016, approximately 24 months) OS was defined as the time from the date of randomization until the date of death. For those participants who have not died, OS was censored at the last date the participant was known to be alive. After termination of the study, collection of tumor assessments and other data to support the efficacy analyses was no longer required in patients who discontinued study treatment. As a result, the presented efficacy results are based on limited data. The total number of reported deaths is shown.
Prostate Specific Antigen Progression-free Survival (PSA PFS) From randomization to the earliest date of PSA progression or death, whichever comes earlier (assessed up to December 2016, approximately 24 months) Prostate specific antigen progression-free survival (PSA PFS) was defined as the time from randomization to the earliest date of PSA progression or death, whichever occurs earlier. Participants who did not progress or die were censored at the last PSA assessment date. After termination of the study, collection of tumor assessments and other data to support the efficacy analyses was no longer required in patients who discontinued study treatment. As a result, the presented efficacy results are based on limited data. The number of participants with reported PSA progression is shown.
Number of Participants Who Experienced Immune-related Adverse Events (irAEs) From first dose of ipilimumab to last dose plus 90 days The total number of participants with immune-related adverse events of any grade is reported for each arm.
Time to Pain Progression From randomization until pain progression (assessed up to December 2016, approximately 24 months) Pain progression was defined as an increase in BPI-SF pain Item #3 score of \>= 2 point from baseline maintained over 2 consecutive periods. After termination of the study, collection of tumor assessments and other data to support the efficacy analyses was no longer required in patients who discontinued study treatment, and presented efficacy results are based on limited data. The number of participants with reported pain progression is shown.
Prostate Specific Antigen Response Rate From baseline to PSA response (assessed up to December 2016, approximately 48 months) PSA response rate was defined as the proportion of participants with a 50% or greater decrease from baseline to the lowest post-baseline PSA result (confirmed 3 weeks later) for each randomized arm. After termination of the study, collection of tumor assessments and other data to support the efficacy analyses was no longer required in patients who discontinued study treatment. As a result, the presented efficacy results are based on limited data. The number of participants showing PSA response is shown.
Trial Locations
- Locations (22)
Istituto Nazionale Tumori Fondazione Pascale
🇮🇹Napoli, Italy
Universitaetsklinikum Aachen
🇩🇪Aachen, Germany
Nebraska Cancer Specialists
🇺🇸Omaha, Nebraska, United States
Uniklinik Heidelberg
🇩🇪Heidelberg, Germany
San Francisco Oncology Associates
🇺🇸San Francisco, California, United States
Baptist Cancer Institute
🇺🇸Jacksonville, Florida, United States
Cancer Center Of Kansas
🇺🇸Wichita, Kansas, United States
Dgu Urologie
🇩🇪Wuppertal, Germany
George Washington University Medical Center
🇺🇸Washington, District of Columbia, United States
North Mississippi Med Center
🇺🇸Tupelo, Mississippi, United States
Northwest Cancer Specialists, Pc
🇺🇸Tualatin, Oregon, United States
Texas Oncology
🇺🇸Houston, Texas, United States
University of Pittsburgh Cancer Institute Cancer Services
🇺🇸Pittsburgh, Pennsylvania, United States
Providence Portland Medical Center
🇺🇸Portland, Oregon, United States
Local Institution
🇬🇧Guildford, Surrey, United Kingdom
Universitaetsklinikum Jena
🇩🇪Jena, Germany
Universitaetsklinikum Magdeburg
🇩🇪Magdeburg, Germany
Universitaetsklinikum Mannheim
🇩🇪Mannheim, Germany
Klinikum rechts der Isar der TU
🇩🇪Muenchen, Germany
Urologische Gemeinschaftspraxis Dres Stammel U. Garcia
🇩🇪Wesel, Germany
Urologische Praxis
🇩🇪Rostock, Germany
Virginia Cancer Institute
🇺🇸Richmond, Virginia, United States