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

August 14, 2019 updated by: Bristol-Myers Squibb

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Prostate Cancer Clinical Trials Working Group 2 (PCWG2)

Response Evaluation Criteria In Solid Tumors (RECIST)

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • St Leonards, New South Wales, Australia, 2065
        • Local Institution
      • Wahroonga, New South Wales, Australia, 2076
        • Local Institution
    • Victoria
      • Parkville, Victoria, Australia, 3050
        • Local Institution
  • Chile
    • Metropolitana
      • Santiago, Metropolitana, Chile
        • Local Institution
    • Santiago DE Chile
      • Recoleta, Santiago DE Chile, Chile
        • Local Institution
    • Valparaiso
      • Vina Del Mar, Valparaiso, Chile, 2540364
        • Local Institution
  • France
      • Clermont Ferrand cedex 01, France, 63011
        • Local Institution
      • Marseille Cedex 9, France, 13273
        • Local Institution
      • Poitiers, France
        • Local Institution
      • Rennes Cedex, France, 35042
        • Local Institution
      • Saint Herblain, France, 44805
        • Local Institution
      • Villejuif, France, 94805
        • Local Institution
  • Germany
      • Aachen, Germany, 52074
        • Universitaetsklinikum Aachen
      • Heidelberg, Germany, 69120
        • Uniklinik Heidelberg
      • Jena, Germany, 07743
        • Universitaetsklinikum Jena
      • Magdeburg, Germany, 39120
        • Universitaetsklinikum Magdeburg
      • Mannheim, Germany, 68167
        • Universitaetsklinikum Mannheim
      • Marktredwitz, Germany, 95615
        • Local Institution
      • Muenchen, Germany, 81675
        • Klinikum rechts der Isar der TU
      • Rostock, Germany, 18107
        • Urologische Praxis
      • Wesel, Germany, 46483
        • Urologische Gemeinschaftspraxis Dres Stammel U. Garcia
      • Wuppertal, Germany, 42103
        • Dgu Urologie
  • Italy
      • Milano, Italy, 20133
        • Local Institution
      • Napoli, Italy, 80131
        • Istituto Nazionale Tumori Fondazione Pascale
  • Netherlands
      • Amsterdam, Netherlands, 1081 HV
        • Local Institution
  • Spain
      • Barcelona, Spain, 08035
        • Local Institution
      • Hospitalet de Llobregat - Barcelona, Spain, 08908
        • Local Institution
      • Sevilla, Spain, 41009
        • Local Institution
      • Valencia, Spain, 46009
        • Local Institution
  • United Kingdom
    • Lanarkshire
      • Glasgow, Lanarkshire, United Kingdom, G12 0YN
        • Local Institution
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
        • Local Institution
    • Surrey
      • Guildford, Surrey, United Kingdom, GU2 7XX
        • Local Institution
  • United States
    • California
      • San Francisco, California, United States, 94115
        • San Francisco Oncology Associates
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • George Washington University Medical Center
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Baptist Cancer Institute
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Cancer Center of Kansas
    • Mississippi
      • Tupelo, Mississippi, United States, 38801
        • North Mississippi Med Center
    • Nebraska
      • Omaha, Nebraska, United States, 68130
        • Nebraska Cancer Specialists
    • Oregon
      • Portland, Oregon, United States, 97213
        • Providence Portland Medical Center
      • Tualatin, Oregon, United States, 97062
        • Northwest Cancer Specialists, PC
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232-1305
        • University of Pittsburgh Cancer Institute Cancer Services
    • Texas
      • Houston, Texas, United States, 77024
        • Texas Oncology
    • Virginia
      • Richmond, Virginia, United States, 23230
        • Virginia Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Drug: Ipilimumab
Other Names:
  • Yervoy™
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
Drug: Ipilimumab
Other Names:
  • Yervoy™

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Experienced Immune-related Adverse Events (irAEs)
Time Frame: 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.
From first dose of ipilimumab to last dose plus 90 days
Overall Survival (OS)
Time Frame: 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.
From randomization to death from any cause (assessed up to December 2016, approximately 24 months)
Prostate Specific Antigen Progression-free Survival (PSA PFS)
Time Frame: 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.
From randomization to the earliest date of PSA progression or death, whichever comes earlier (assessed up to December 2016, approximately 24 months)
Time to Pain Progression
Time Frame: 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.
From randomization until pain progression (assessed up to December 2016, approximately 24 months)
Prostate Specific Antigen Response Rate
Time Frame: 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.
From baseline to PSA response (assessed up to December 2016, approximately 48 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 2, 2014

Primary Completion (Actual)

December 15, 2016

Study Completion (Actual)

December 15, 2016

Study Registration Dates

First Submitted

October 29, 2014

First Submitted That Met QC Criteria

October 29, 2014

First Posted (Estimate)

October 31, 2014

Study Record Updates

Last Update Posted (Actual)

August 28, 2019

Last Update Submitted That Met QC Criteria

August 14, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA184-437
  • 2014-002987-34 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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