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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02279862
• Other study ID #: CA184-437
• Secondary ID: 2014-002987-34
• Status: Completed
• Phase: Phase 2
• Start date: December 2, 2014
• Est. completion date: December 15, 2016

Study information

• Verified date: August 2019
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Prostate Cancer Clinical Trials Working Group 2 (PCWG2)

Response Evaluation Criteria In Solid Tumors (RECIST)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: December 15, 2016
• Est. primary completion date: December 15, 2016
• 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:

• 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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Ipilimumab

Locations

Country	Name	City	State
Australia	Local Institution	Parkville	Victoria
Australia	Local Institution	St Leonards	New South Wales
Australia	Local Institution	Wahroonga	New South Wales
Chile	Local Institution	Recoleta	Santiago DE Chile
Chile	Local Institution	Santiago	Metropolitana
Chile	Local Institution	Vina Del Mar	Valparaiso
France	Local Institution	Clermont Ferrand cedex 01
France	Local Institution	Marseille Cedex 9
France	Local Institution	Poitiers
France	Local Institution	Rennes Cedex
France	Local Institution	Saint Herblain
France	Local Institution	Villejuif
Germany	Universitaetsklinikum Aachen	Aachen
Germany	Uniklinik Heidelberg	Heidelberg
Germany	Universitaetsklinikum Jena	Jena
Germany	Universitaetsklinikum Magdeburg	Magdeburg
Germany	Universitaetsklinikum Mannheim	Mannheim
Germany	Local Institution	Marktredwitz
Germany	Klinikum rechts der Isar der TU	Muenchen
Germany	Urologische Praxis	Rostock
Germany	Urologische Gemeinschaftspraxis Dres Stammel U. Garcia	Wesel
Germany	Dgu Urologie	Wuppertal
Italy	Local Institution	Milano
Italy	Istituto Nazionale Tumori Fondazione Pascale	Napoli
Netherlands	Local Institution	Amsterdam
Spain	Local Institution	Barcelona
Spain	Local Institution	Hospitalet de Llobregat - Barcelona
Spain	Local Institution	Sevilla
Spain	Local Institution	Valencia
United Kingdom	Local Institution	Glasgow	Lanarkshire
United Kingdom	Local Institution	Guildford	Surrey
United Kingdom	Local Institution	Nottingham	Nottinghamshire
United States	Texas Oncology	Houston	Texas
United States	Baptist Cancer Institute	Jacksonville	Florida
United States	Nebraska Cancer Specialists	Omaha	Nebraska
United States	University of Pittsburgh Cancer Institute Cancer Services	Pittsburgh	Pennsylvania
United States	Providence Portland Medical Center	Portland	Oregon
United States	Virginia Cancer Institute	Richmond	Virginia
United States	San Francisco Oncology Associates	San Francisco	California
United States	Northwest Cancer Specialists, Pc	Tualatin	Oregon
United States	North Mississippi Med Center	Tupelo	Mississippi
United States	George Washington University Medical Center	Washington	District of Columbia
United States	Cancer Center Of Kansas	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Australia,  Chile,  France,  Germany,  Italy,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiographic Progression-free Survival (rPFS)	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	Number of Participants Who Experienced Immune-related Adverse Events (irAEs)	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
Secondary	Overall Survival (OS)	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)
Secondary	Prostate Specific Antigen Progression-free Survival (PSA PFS)	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)
Secondary	Time to Pain Progression	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)
Secondary	Prostate Specific Antigen Response Rate	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)

External Links

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